Clinical trial NCT04143035: Hemodynamic Resuscitation and Monitoring in Early Sepsis
Official title: Hemodynamic Resuscitation and Monitoring in Early Sepsis
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Septic Shock
Lead sponsor: Tata Memorial Centre
Sponsor class: OTHER
Collaborators: name: Indian Society of Critical Care Medicine
First posted: 2019-10-29
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Adult patients presenting to ICU with suspected sepsis and hypotension

Brief summary: "Hemodynamic Resuscitation and Monitoring in Early Sepsis (HERMES Study)" involves recording of patient's medical data related to that has been collected as part of his/her routine medical care in ICU.

Presently there is no data from Indian ICUs on the way patients in early sepsis are resuscitated and monitored. There may exist a wide variation in clinical practice. The investigators would like to conduct an observational study in various levels of Indian ICUs, to prospectively collect data on adult patients admitted to ICU with early sepsis in a 60-day window period. Investigator would like to study the hemodynamic resuscitation and monitoring performed in these patients. In addition, Investigator would like to identify factors associated with improved outcomes and achieving the goals of the sepsis bundles in one, three and six hours.

The objectives of the study is to capture the patient characteristics and hemodynamic resuscitation and monitoring practices in patients presenting with early sepsis and hypotension to Indian ICUs

Investigator plan to recruit 50 -100 centers nationwide. Each center will be asked to collect data from at least 10 patients in a maximum time window of 60 days. A convenience sample of minimum 500 patients presenting to ICU with suspected sepsis and hypotension will be taken.

Each Centre will guarantee the integrity of data collection and ensure timely completion of the case record forms. Each center will select a 60 day window period for patient recruitment. The start date may be anytime any time between 1st August to 15th October 2019. Therefore, the recruitment window period will end for a respective centre, anytime between 30th September and 14th December 2019, depending on the start date. All consecutive patients in the 60-day period will be screened and those eligible will be enrolled.

This is an ISCCM(Indian Society of Critical Care Medicine) Research Committee funded study. The ISCCM will fund the Principal Investigator for all expenses related software development, website hosting, secretarial assistance and miscellaneous expenses related to the conduct of the study, data analysis and publication. No funding will be given to the investigators from the various participating centers for contributing data.

Detailed description: INTRODUCTION Septic shock is the most commonly occurring of all types of shock.The Third International Consensus Definitions for Sepsis and Septic Shock (Sepsis-3) defines septic shock as a subset of sepsis in which particularly profound circulatory, cellular, and metabolic abnormalities are associated with a greater risk of mortality than with sepsis alone. Patients with septic shock can be clinically identified by a vasopressor requirement to maintain a mean arterial pressure of 65 mm Hg or greater and serum lactate level greater than 2 mmol/L (\>18 mg/dL) in the absence of hypovolemia. This combination is associated with hospital mortality rates greater than 40%.

The "sepsis bundle" has been central to the implementation of the Surviving Sepsis Campaign (SSC) from the first publication of its evidence-based guidelines in 2004 through subsequent editions. Developed separately from the guidelines publication by the SSC, the bundles have been the cornerstone of sepsis quality improvement since 2005. An updated version was published in 2016 "Surviving Sepsis Campaign: International Guidelines for Management of Sepsis and Septic Shock". There is compelling nature of the evidence in the literature which demonstrates an association between compliance with bundles and improved survival in patients with sepsis and septic shock. This has led to the adoption of the SSC measures by the National Quality Forum (NQF) and other departments. The important relationship between the bundles and survival was confirmed in a publication from this initiative.

The Surviving Sepsis Campaign released an updated one-hour sepsis bundle, which combines recommendations listed in the three-hour and six-hour bundles. This includes 5 elements: 1. measuring lactate levels 2. obtaining blood cultures before administering antibiotics 3. administering broad-spectrum antibiotics 4. fluid resuscitation for hypotension or lactate level ≥ 4 mmol/L and 5. use of vasopressors for hypotensive during or after fluid resuscitation to maintain MAP ≥ 65 mm Hg.

Presently there is no data from Indian ICUs on the way patients in early sepsis are resuscitated and monitored. There may exist a wide variation in clinical practice.The Investigator would like to conduct an observational study in various levels of Indian ICUs, to prospectively collect data on adult patients admitted to ICU with early sepsis in a 60-day window period. Investigator would like to study the hemodynamic resuscitation and monitoring performed in these patients. In addition, investigator would like to identify factors associated with improved outcomes and fulfilling the goals of the one hour SSC bundles within one, three and six hours in patients with sepsis and septic shock.

OBJECTIVES

1. To capture the patient characteristics and hemodynamic resuscitation and monitoring practices in patient presenting with early sepsis and hypotension to Indian ICUs
2. To determine various factors associated with improved survival in patients with septic shock
3. To determine factors associated with achieving the 1 hour, 3 hour and 6-hour resuscitation goals of the sepsis bundle in patients with septic shock

METHODS Study design- Prospective observational multi-center national cohort study.

Patient Recruitment

ISCCM members across India will be contacted to register their ICUs in the study, through emails sent from the ISCCM Research committee. Repeated emails will be sent over a two-month period. Hospitals with more than one ICU can enroll each of their ICUs separately. Each ICU will need to contribute a minimum of 10 adult patients with sepsis and hypotension in a 60 day window period.

Each center will designate a maximum of two local coordinators (PI and Co-PI) who will provide scientific and structural leadership in their centers. They will ensure that all local necessary ethical and regulatory approvals are obtained before the start of patient inclusion.

Local coordinators will guarantee the integrity of data collection and ensure timely completion of the case record forms. Each center will select a 60 day window period for patient recruitment. The start date may be anytime any time between 1st August to 15th October 2019. Therefore, the recruitment window period will end for a respective centre, anytime between 30th September and 14th December 2019, depending on the start date. All consecutive patients in the 60-day period will be screened and those eligible will be enrolled.

Data Collection

1. There will be no direct patient contact or intervention. Local coordinators will guarantee the integrity of data collection and ensure timely completion of CRFs (case record forms). Date related to the following will be collected prospectively from the charts:
2. Patient demographic data e.g. age, sex, comorbidities, likely source of sepsis
3. Total number of ICU patients, patients with sepsis and septic shock admitted to the ICU in the 60 days period
4. Patient clinical examination findings and severity of illness
5. Details of hemodynamic monitoring and other systemic monitoring and therapy performed in ICU e.g. fluid bolus, vasopressor agents, monitoring devices used, hemodynamic variables measured, mechanical ventilation, dialysis etc. in the first 3 days of ICU admission
6. Antibiotics administered and details of microbiology examinations
7. Adjunct therapies initiated for sepsis
8. ICU, hospital and 28-day mortality

Sample size The primary endpoint of study was to determine the incidence of ICU mortality in patients with septic shock admitted to Indian ICUs. The sample size calculation was done on the basis of INDICAPS I(Indian Intensive Care Case Mix and Practice Patterns Study-I) Study data (IJCCM April 2016). In this study the ICU mortality incidence was found to be 45% in patients with septic shock. Assuming the incidence rate found in this study, a sample size of 401 produces a two-sided 95% confidence interval with a width equal to 0.100 when the sample proportion is 0.450. Sample size calculation was done using PASS software. To account for attrition, Investigator will take a sample size of at least 450 patients. Investigator plan to recruit 50 -100 centers nationwide. Each center will be asked to collect data from at least 10 patients, hence investigator should be able to meet this target of \>450 patients.

Statistical analysis The primary objective of the study is to determine the patient characteristics and hemodynamic resuscitation and monitoring practices in patient presenting with early sepsis and hypotension to Indian ICUs which will be analyzed using descriptive statistics. To determine various factors associated with improved survival in patients with septic shock investigator will use the Fisher's exact test or Pearson's χ2 test. Univariable and Multivariable logistic regression models will be developed to assess the independent effects on ICU mortality. To determine factors associated with achieving the 1 hour SSC Sepsis resuscitation bundle in 1 hour, 3 hours and 6-hours in patients with sepsis and septic shock will be assessed by Fisher's exact test or Pearson's χ2 test. Univariable and Multivariable logistic regression models will be developed to assess the independent effects on ICU mortality of the 1 hour, 3 hour and 6-hour resuscitation goals of the sepsis bundle in patients with sepsis and septic shock. The overall performance of the internally validated model will be assessed using Nagelkerke's R2 (R squared in logistic regression). The higher Nagelkerke's R2, the greater the strength of the model. The ability of the models to identify ICU mortality will be quantified as the area under the receiver operating characteristic curve (AUC). The AUC ranges from 50% to 100%, indicating no discriminative capacity to perfect discriminative capacity. The agreement between predicted probabilities and observed frequencies of the outcome will be assessed by visually inspecting the calibration plot. Last, the Hosmer and Lemeshow goodness-of-fit statistic will be computed as a quantitative measure of accuracy. A high outcome of this statistic is related to a low p-value, which indicates a poor fit. All analysis will two sided, and significance will set at a p-value of 0.05. Statistical analyses will be performed using SPSS (the statistical package for social sciences) IBM Corp. Released 2017. IBM SPSS Statistics for Windows, Version 25.0. Armonk, New York: IBM Corp and R studio (version 1.2).

INSTITUTIONAL ETHICS COMMITTEE (IEC) APPROVAL The local hospital investigators should ensure that all necessary local ethical and regulatory approvals are obtained if required, before the start of the study in their institution.

CONSENT FOR DATA COLLECTION This is an observational study and involves capture of data from the patient charts. There is no direct patient contact or intervention, hence written, informed consent is not mandatory. However, if required by the institution, consent may be taken from the patients legally accepted representative (LAR). Sample short consent forms for patient data capture will be provided by the PI in English, Hindi and Marathi. This may be translated in various regional languages as required by the local investigator

STUDY FUNDING This is an ISCCM Research Committee funded study. The ISCCM will fund the Principal Investigator institution for all expenses related software development, website hosting, secretarial assistance and miscellaneous expenses related to the conduct of the study, data analysis and publication (against actual bills). No funding will be given to the investigators from the various participating centres for contributing data.

DATA STORAGE AND OWNERSHIP The Principal Investigator will have ownership of the data. The data will be stored in the Principal Investigators department at Tata Memorial Hospital, Mumbai for 10 years.

PUBLICATION AND AUTHORSHIP POLICY The main results of study will be published in a peer-reviewed medical journal. Authorship policy will follow the International Committee of Medical Journal Editors (ICMJE) recommendations. Authorship will be considered based on contributions the study design and protocol development, recruitment of patients, data acquisition and cleaning, analysis and interpretation of the data, manuscript writing and final approval of the version to be published and agreement to be accountable for all aspects of the work, in ensuring that questions related to the accuracy or integrity of any part of the work are appropriately investigated and resolved.

Steering Committee - Members of the Steering Committee will include 7 members from the Principal Investigators center and 8 -10 experts from across the country. They will be involved and provide active guidance from inception till publication of the study.

Writing committee and main author list - Members of the steering committee and Principal Investigator from the top 3 centers with highest number of patient recruitment.

The Principal Investigator and Co-Principal Investigator from each participating ICU will be in the list of study collaborators and their names will be in the publication. The names of all the investigators will be indexed in PubMed depending on the journal policy.

SECONDARY ANALYSES After publication of the primary results, on request, the pooled dataset will be available for investigators for secondary analysis, after judgment and approval of scientific quality and validity by the steering committee. Before submission, the final version of all manuscripts related to the study dataset must be approved by the steering committee. The members of the writing committee will be authors of the publications derived from the study dataset.

Eligibility criteria: Inclusion criteria

1. Adult patients (≥ 18 years old)
2. Presenting to ICU with suspected sepsis
3. Presence of hypotension (Systolic BP ≤ 90 mmHg / Mean arterial pressure (MAP) ≤ 65mmhg or patient with Systolic BP \> 90 mmHg / MAP \>65mmHg on vasopressor.

Exclusion Criteria

1. Patient likely to be in shock due to reason other than sepsis (e.g. cardiogenic or hemorrhagic shock)
2. Decision taken for not intubating / ventilating /aggressive resuscitation prior to ICU admission
3. Patient transferred from another ICU OR another hospital (only if stay \>7 days)

Primary outcomes:
measure: ICU Mortality
timeFrame: throughout ICU stay till discharge (up to 2 months)
measure: Completing the elements of the one hour SSC sepsis bundle in one 1 hour
timeFrame: 1 hour after admission upto 60 days from the study start date in respective study site (60 days)
Secondary outcomes:
measure: Hospital mortality
timeFrame: throughout the hospital stay till discharge in the respective study site (up to 3 months)
measure: 28-day mortality
timeFrame: From ICU admission to 28 days in the respective study site (up to 3 months)
measure: Completing the elements of the one hour SSC sepsis bundle in one, three and six hours
timeFrame: 1 hour, 3 hour and six hour after admission upto 60 days from the study start date in the respective study site (60 days )
Other outcomes:
Locations:
city: Patna
country: India
facility: AIIMS Patna
state: Bihar
city: Patna
country: India
facility: All india institute of medical sciences
state: Bihar
city: Jabalpur
country: India
facility: Anant Institute of Medical Sciences
state: Madhya Pradesh
city: Mumbai
country: India
facility: Breach Candy Hospital Trust
state: Maharashtra
city: Nagpur
country: India
facility: Criticare Hospital and Research Institute
state: Maharashtra
city: Pune
country: India
facility: Galaxy care hospital
state: Maharashtra
city: Pune
country: India
facility: Sanjeevan Hospital
state: Maharashtra
city: Ludhiyana
country: India
facility: Dayanand Medical College and Hospital
state: Panjab
city: Jaipur
country: India
facility: Eternal Hospital
state: Rajasthan
city: Udaipur,
country: India
facility: Kamlesh Kanwar Shekhawat
state: Rajasthan
city: Udaipur
country: India
facility: Pims
state: Rajasthan
city: Faridabad
country: India
facility: Sarvodaya hospital and research centre
state: Uttar Pradesh
city: Kanpur
country: India
facility: Fortune Hospital
state: Uttar Pradesh
city: Varanasi
country: India
facility: Sir Sundar lal Hospital, IMS, BHU, Varanasi
state: Uttar Pradesh
city: Varanasi
country: India
facility: Sir Sunderlal Hospital
state: Uttar Pradesh
city: Agra
country: India
facility: Nayati Hospital - Trauma & Acute Care Centre
city: Agra
country: India
facility: Purushottam das Savitri Devi Cancer center
city: Agra
country: India
facility: Pushpanjali Hospital
city: Agra
country: India
facility: Rainbow Hospitals
city: Ahmedabad
country: India
facility: Narayana Multispeciality Hospital
city: Ahmedabad
country: India
facility: Sterling hospital
city: Ahmedabad
country: India
facility: Zydus Hospitals Ahmedabad
city: Ahmednagar
country: India
facility: Saideep Healthcare and Research Pvt Ltd
city: Alīgarh
country: India
facility: J N Medical College & Hospital
city: Alīgarh
country: India
facility: Ohm Trauma centre and critical care
city: Amritsar
country: India
facility: Emc hospital
city: Amritsar
country: India
facility: Fortis Escorts Hospital Amritsar
city: Aurangabad
country: India
facility: Kamalnayan Bajaj hospital
city: Aurangabad
country: India
facility: Mgm Medical College Hospital and Medical Centre Research Institute(McRi)
city: Aurangabad
country: India
facility: Oriion Citicare Superspeciality Hospital
city: Aurangabad
country: India
facility: Shraddha hospital and critical care center
city: Bangalore
country: India
facility: Bhagwan Mahaveer Jain Hospital
city: Bangalore
country: India
facility: Columbiaasia Referral Hospital, Yeshwantpur
city: Bangalore
country: India
facility: Cytecare Cancer Hospital
city: Bangalore
country: India
facility: Health care Global (HCG)
city: Bangalore
country: India
facility: Shifaa hospital
city: Bareilly
country: India
facility: Shri Ram Murti Smarak Institute of Medical Sciences
city: Barnagar
country: India
facility: Geeta Hospital and research centre
city: Bengaluru
country: India
facility: Aster R V Hospital
city: Bengaluru
country: India
facility: Manipal hospital
city: Bengaluru
country: India
facility: Mazumdar Shaw Medical Center
city: Bengaluru
country: India
facility: Regal Hospital
city: Bengaluru
country: India
facility: St John's Medical College Hospital
city: Bengaluru
country: India
facility: Vydehi Institute of Medical Sciences and Research Centre
city: Bhubaneshwar
country: India
facility: Apollo Hospitals
city: Bhubaneswar
country: India
facility: Amri hospital ICU -1
city: Bhubaneswar
country: India
facility: AMRI Hospitals
city: Bhubaneswar
country: India
facility: Amri Hospital
city: Bhubaneswar
country: India
facility: Apollo Hospitals
city: Bhubaneswar
country: India
facility: Apollo Hospital
city: Bhubaneswar
country: India
facility: BR Life Kalinga Hispital
city: Bhubaneswar
country: India
facility: Care Hospitals
city: Bhubaneswar
country: India
facility: Care Hospital
city: Bidar
country: India
facility: Gudage Hospital
city: Bijapur
country: India
facility: Ayush Hospital
city: Bilaspur
country: India
facility: Apollo Hospital Icu-1
city: Bilaspur
country: India
facility: Apollo Hospital
city: Bokāro
country: India
facility: K.M.Memorial hospital and research centre
city: Chandigarh
country: India
facility: PGIMER
city: Chennai
country: India
facility: Apollo Hospitals Enterprise limited
city: Chennai
country: India
facility: Billroth hospital
city: Chennai
country: India
facility: Dr.Rela Institute and Medical Centre
city: Chennai
country: India
facility: Mgm Healthcare Ltd.
city: Chennai
country: India
facility: Sri Ramachandra Hospital
city: Chennai
country: India
facility: Sri Ramchandra Medical Centre
city: Cochin
country: India
facility: MOSC Medical College
city: Coimbatore
country: India
facility: Kovai Medical Center Hospital and Research
city: Coimbatore
country: India
facility: Royal Care Super Speciality Hospital
city: Cuttack
country: India
facility: Ashwini Hospital
city: Cuttack
country: India
facility: Goodluck Hospital
city: Cuttack
country: India
facility: Scb Medical College and Hospital
city: Cuttack
country: India
facility: SCB Medical College
city: Darbhanga
country: India
facility: Paras Global Hospital
city: Delhi
country: India
facility: Dharmshila Narayana Superspeciality Hospital
city: Delhi
country: India
facility: Dr. Ram Manohar Lohia Hospital ,New Delhi
city: Delhi
country: India
facility: Dr. Ram Manohar Lohia Hospital
city: Delhi
country: India
facility: kailash Hospital and heart Institute
city: Delhi
country: India
facility: Pushpawati Singhania Research Institute
city: Delhi
country: India
facility: Sir Ganga Ram Hospital
city: Dervan
country: India
facility: BKL Walawalkar Hospital
city: Erode
country: India
facility: Muthukrishnan Periasamy
city: Faridabad
country: India
facility: Qrg Healthcity
city: Ghāziābād
country: India
facility: Yashoda super specialty hospital, kaushambi
city: Gorakhpur
country: India
facility: City Hospital
city: Guntur
country: India
facility: Dr.Ramesh Cardiac and Multiplicity PVT LTD
city: Guntur
country: India
facility: GBR super speciality hospitals
city: Guntur
country: India
facility: Lalitha Super Specialities Hospital
city: Guntur
country: India
facility: Samistha Hospital and Research Institute
city: Gurgaon
country: India
facility: Medanta Medicity
city: Gurgaon
country: India
facility: Medanta the medicity hospital
city: Gurgaon
country: India
facility: Medanta the medicity
city: Gurgaon
country: India
facility: Narayana Super Specialty Hospital
city: Gurgaon
country: India
facility: VPS Medeor Hospital
city: Guwahati
country: India
facility: Apollo Hospitals Guwahati
city: Guwahati
country: India
facility: Apollo hospitals
city: Guwahati
country: India
facility: Ayursundra Superspecialty hospital
city: Guwahati
country: India
facility: Dispur Hospitals pvt Ltd
city: Guwahati
country: India
facility: Gnrc Hospitas, Dispur
city: Guwahati
country: India
facility: Health City
city: Guwahati
country: India
facility: Nemcare Hospital
city: Hosur
country: India
facility: Santhi Hospital
city: Hyderabad
country: India
facility: Aig Hospitals, Gachibowli
city: Hyderabad
country: India
facility: Apollo Health City ICU-1
city: Hyderabad
country: India
facility: Apollo health city
city: Hyderabad
country: India
facility: Aware Gleneagles Global Hospital
city: Hyderabad
country: India
facility: Care hospital and institute of medical sciences
city: Hyderabad
country: India
facility: Care hospitals banjara
city: Hyderabad
country: India
facility: CENTURY hospital
city: Hyderabad
country: India
facility: Century Super Speciality Hospital
city: Hyderabad
country: India
facility: Continental Hospitals
city: Hyderabad
country: India
facility: Gleneagles Global Hospital
city: Hyderabad
country: India
facility: Krishna Institute of Medical Sciences
city: Hyderabad
country: India
facility: Rainbow childrnes hospital
city: Hyderabad
country: India
facility: South Central Railway Hospital ICU-1
city: Hyderabad
country: India
facility: South Central Railway Hospital
city: Hyderabad
country: India
facility: Virinchi Hospital
city: Hyderabad
country: India
facility: Yashoda Hospital
city: Indore
country: India
facility: Choithram hospital
city: Jabalpur
country: India
facility: Dodeja Hospital
city: Jaipur
country: India
facility: Apex Hospital
city: Jaipur
country: India
facility: Manipal hospital
city: Jaipur
country: India
facility: Shubh Hospital
city: Jalandhar
country: India
facility: shrimann superspeciality hospital ICU-1
city: Jalandhar
country: India
facility: Shrimann Superspeciality Hospital
city: Jalgaon
country: India
facility: Kripa Critical Care and Trauma Centre
city: Jammu
country: India
facility: Smvd Narayana Superspeciality Hospital
city: Jamshedpur
country: India
facility: Tata Main Hospital
city: Jodhpur
country: India
facility: All India Institute of Medical Sciences, jodhpur
city: Kalyan
country: India
facility: Ved Hospital
city: Kanpur
country: India
facility: Abha superspeciality hospital
city: Kanpur
country: India
facility: Regency hospital ltd tower 1
city: Karamsad
country: India
facility: Shree krishna hospital ICU-1
city: Karamsad
country: India
facility: Shree Krishna Hospital
city: Khammam
country: India
facility: Sankalpa hospital
city: Kochi
country: India
facility: Amrita institute of Medical Sciences
city: Kolkata
country: India
facility: AMRI Hospital Mukundapur
city: Kolkata
country: India
facility: AMRI Hospital, DHAKURIA
city: Kolkata
country: India
facility: Apollo Gleneagles Hospital
city: Kolkata
country: India
facility: Bellevue Clinic
city: Kolkata
country: India
facility: Fortis Hospital Anandapur
city: Kolkata
country: India
facility: Institute of Neurosciences Kolkata
city: Kolkata
country: India
facility: Medica Superspecialty Hospital
city: Kolkata
country: India
facility: Peerless Hospitex Hospital and Research Center Limited
city: Kolkata
country: India
facility: Tata Medical Center
city: Kollam
country: India
facility: Travancore medical college,medicity
city: Kottayam
country: India
facility: Govt.Medical college
city: Lucknow
country: India
facility: King George's Medical University
city: Ludhiana
country: India
facility: Christian Medical College
city: Madurai
country: India
facility: Apollo speciality hospital
city: Manipala
country: India
facility: Kasturba medical college, Manipal
city: Mathura
country: India
facility: Nayati medicity hospital
city: Meerut
country: India
facility: Manglam Hosp
city: Meerut
country: India
facility: Metro Hospital and heart Institute
city: Mohali
country: India
facility: Cheema Medical Complex
city: Mohali
country: India
facility: Fortis Hospital
city: Mohali
country: India
facility: MAX Superspecialty Hospital
city: Mumbai
country: India
facility: Asian Cancer Institute
city: Mumbai
country: India
facility: Bhatia Hospital
city: Mumbai
country: India
facility: Dr L H HIRANANDANI HOSPITAL
city: Mumbai
country: India
facility: Fortis hiranandani hospital
city: Mumbai
country: India
facility: Fortis Hospital Mulund
city: Mumbai
country: India
facility: Fortis hospitals
city: Mumbai
country: India
facility: Global Hospital,Parel
city: Mumbai
country: India
facility: Global Hospital
city: Mumbai
country: India
facility: Holy Family Hospital
city: Mumbai
country: India
facility: Nanavati Hospital Icu-1
city: Mumbai
country: India
facility: Nanavati hospital ICU-2
city: Mumbai
country: India
facility: Nanavati Hospital Icu-3
city: Mumbai
country: India
facility: Nanavati Hospital
city: Mumbai
country: India
facility: Nanavati hosptial
city: Mumbai
country: India
facility: Pd Hinduja National Hospital and Mrc
city: Mumbai
country: India
facility: s.l.Rahej hospital- a fortis associate
city: Mumbai
country: India
facility: Sir H N Reliance Foundation Hospital
city: Mumbai
country: India
facility: Suasth Health Care
city: Mumbai
country: India
facility: Tata Memorial Hospital (FICU)
city: Mumbai
country: India
facility: Tata Memorial Hospital (SICU)
city: Mumbai
country: India
facility: Wockhardt Hopsital South Mumbai
city: Mysore
country: India
facility: Cauvery Heart and multispeciality hospital
city: Mysore
country: India
facility: Jss Hospital
city: Mysuru
country: India
facility: Gopalagowda Shanthaveri Memorial Hospital
city: Nagpur
country: India
facility: Aditya Hospital
city: Nagpur
country: India
facility: Dew medicare and Trinity Hospital
city: Nagpur
country: India
facility: Dr V E Tambe Critical Care
city: Nagpur
country: India
facility: Meditrina Institute Of Medical Scineces
city: Nagpur
country: India
facility: Orange City Hospital And Research Institute
city: Nagpur
country: India
facility: Rahate Surgical Hospital and Iccu
city: Nagpur
country: India
facility: Shree Hospital and Critical Care Centre
city: Nashik
country: India
facility: Apollo Hospitals
city: Navi Mumbai
country: India
facility: National Burns Centre
city: Nellore,
country: India
facility: Simhapuri Hospital
city: Nellore
country: India
facility: Narayana Medical College Icu-1
city: Nellore
country: India
facility: Narayana Medical College
city: New Delhi
country: India
facility: Batra Hospital & Medical Research Center
city: New Delhi
country: India
facility: Batra Hospital
city: New Delhi
country: India
facility: BLK hospital
city: New Delhi
country: India
facility: Blk Superspeciality Hospital
city: New Delhi
country: India
facility: Fortis Escorts Heart Institute
city: New Delhi
country: India
facility: Fortis Hospital, Shalimar Bagh
city: New Delhi
country: India
facility: GB Pant Institute of Post Graduate Medical Education & Research
city: New Delhi
country: India
facility: Indraprastha Apollo Hospitals ICU-1
city: New Delhi
country: India
facility: Indraprastha apollo hospitals
city: New Delhi
country: India
facility: Max Super Specialty Hospital Patparganj
city: New Delhi
country: India
facility: Northern railway central hospital
city: New Delhi
country: India
facility: Sri balaji action medical institute ICU-1
city: New Delhi
country: India
facility: Sri Balaji Action Medical Institute
city: New Delhi
country: India
facility: Venkateshwar Hospital
city: Noida
country: India
facility: Fortis Hospital
city: Noida
country: India
facility: Promhex Multispeciality Hospital
city: Panchkula
country: India
facility: Ojas hospital
city: Patna
country: India
facility: All India Institute of Medical Sciences Patna
city: Patna
country: India
facility: Indira Gandhi Institute of Medical Sciences
city: Patna
country: India
facility: Prabhat Kumar
city: Pune
country: India
facility: Bharati Vidyapeeth Deemed university and Medical College Hospital
city: Pune
country: India
facility: Columbia Asia hospital
city: Pune
country: India
facility: Jupiter Hospital
city: Pune
country: India
facility: Niramaya Hoapital
city: Pune
country: India
facility: Ruby Hall Clinic Icu-1
city: Pune
country: India
facility: Ruby Hall Clinic ICU-2
city: Pune
country: India
facility: Vishwaraj Hospital & Research Centre
city: Pune
country: India
facility: Vishwaraj Hospital& Research Center
city: Raipur
country: India
facility: Om Hospital
city: Raipur
country: India
facility: Pt. J. N. M. Medical College
city: Raipur
country: India
facility: Ramskrishna care hospital
city: Raipur
country: India
facility: Shree Narayana Hospital
city: Rajkot
country: India
facility: Genesis Multispeciality Hospital
city: Rajkot
country: India
facility: Shree Giriraj Multispecialty Hospital
city: Rajkot
country: India
facility: Sterling Hospital, Rajkot (A Division of Sterling Addlife India Private Limited)
city: Rajkot
country: India
facility: Synergy superspeciality hospital
city: Ranchi
country: India
facility: Bhagwan Mahavir Medica Superspecialty Hospital
city: Rājkot
country: India
facility: Shree Giriraj Multispeciality hospital
city: Sagar
country: India
facility: Sagarshree Hospital
city: Srinagar
country: India
facility: Abdul Waheed Mir
city: Srinagar
country: India
facility: Sheri Kashmir Institute of Medical Sciences
city: Surat
country: India
facility: Kiran Hospital
city: Surat
country: India
facility: Shree Sardar Smarak Hospital
city: Sāgar
country: India
facility: Sagarshree Hospital
city: Tiruvalla
country: India
facility: Believers Church Medical College and Hospital
city: Trichinopoly
country: India
facility: Trichy Srm Medical College Hospital & Research Centre
city: Trivandrum
country: India
facility: Kerala Institute of Medical sciences
city: Tumuluru
country: India
facility: Siddaganga hospital and research centre
city: Vadodara
country: India
facility: Sterling Hospitals
city: Varanasi
country: India
facility: Homi Bhaba Cancer Hospital & Pandit Madan Mohan Malviya Cancer Centre,Tata Memorial Centre,Varanasi
city: Varanasi
country: India
facility: S S Hospital BHU VARANASI
city: Vellore
country: India
facility: Christian Medical College
city: Vijayawada
country: India
facility: Nagarjuna hospital
city: Visakhapatnam
country: India
facility: St Ann Hospital
city: Warangal
country: India
facility: Samraksha super speciality
city: Wardha
country: India
facility: Arnam Hospital
Study officials:
affiliation: Tata Memorial Hospital, Parel, Mumbai-12
name: Sheila N Myatra, MD
role: PRINCIPAL_INVESTIGATOR
References:
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