Clinical trial NCT06516692: Inferior Vena Cava Collapsibility and Distensibility Assessment in Critical Care.
Official title: (IVCIN TRIAL) Outcomes of Patient Admitted to Critical Care Unit with Vs Without Inferior Vena Cava Collapsibility and Distensibility Assessment. a Randomized Clinical Trial in Pakistan.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sepsis
Acute Renal Failure
Acute Gastroenteritis
Diabetic Ketoacidosis
Keywords: Inferior Vena Cava Collapsibility and Distensibility index
Fluid management
Resuscitation
Clinical parameters
Sepsis
Acute gastroenteritis
Acute Renal failure
Diabetic ketoacidosis
Mortality
Cumulative fluid balance
Lactic acid
Sequential Organ Failure Assessment score
Mechanical Ventilation
Critical Care
Lead sponsor: Jinnah Postgraduate Medical Centre
Sponsor class: OTHER_GOV
First posted: 2024-07-24
Enrollment: 180
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: This study will help in determining the impact of assessment of Inferior Vena Cava Collapsibility and Distensibility Index (IVC CI and DI) through Point Of Care Ultra Sound (POCUS), for the fluid management of critically ill patients. This would help in better management of such patients in resource limited countries, where costly equipment for cardiac output monitoring and fluid management are frequently not available.

Moreover this study will help in development of future guidelines for fluid resuscitation in critically ill patients.

Detailed description: The current study is a randomized clinical trial with the aim to explore comparative outcome between IVC CI and DI versus clinical parameters guided fluid management groups in patients of sepsis, Acute renal failure, Acute gastroenteritis and Diabetic ketoacidosis in terms of,

1. Within 24 hours 7 day and 28 day mortality
2. Change in Sequential Organ failure Assessment (ΔSOFA) score from baseline to 24 hours after fluid management.
3. Cumulative fluid balance at 6 hours of fluid management
4. Days on mechanical ventilation
5. Days in Intensive Care Unit (ICU)
6. Change in lactic acid levels in sepsis sub group
7. Change in Blood sugar Random (BSR) in Diabetic ketoacidosis (DKA) sub group
8. Change in Power of Hydrogen (PH) in septic and diabetic ketoacidosis sub group of participant

Eligibility criteria: Inclusion Criteria:

* Patients admitted in critical care with systolic Blood Pressure \< 90 mmHg with any of the diagnosis as per operational definition:
* Sepsis
* Diabetic ketoacidosis
* Acute kidney injury
* Acute gastroenteritis

Exclusion Criteria:

* Known case of right heart disease
* Known case of congestive cardiac failure
* Presence of marked ascites
* IVC could not be identified or diameter could not be measured
* Pregnant females
* Body Mass Index (BMI) \>30 Kg/meter2

Primary outcomes:
measure: Within 24-hours, 7-day and 28 day mortalities
timeFrame: Mortalities will be assessed and recorded within 24hour, then day 7 up to 28th day.
measure: Cumulative fluid balance
timeFrame: At 6 hours of enrolment of participant
measure: Change in Sequential Organ Failure Assessment score(Δ SOFA)
timeFrame: At 24 hours of enrolment
Secondary outcomes:
measure: Days in Intensive Care Unit (ICU)
timeFrame: ICU days up to 28 day
measure: Days on mechanical ventilation
timeFrame: Days in which participant will be on mechanical ventilation up to 28 days
measure: Change in lactic acid levels in septic patient
timeFrame: At 6 hours of enrolment of participant
measure: Change in Blood Sugar random (BSR) levels in patients with diabetic ketoacidosis
timeFrame: At 6 hours of enrolment of participant
measure: Change in Power of hydrogen (PH) in patients with sepsis and diabetic ketoacidosis
timeFrame: At 6 hours of enrolment of participant
Other outcomes:
Locations:
city: Karachi
country: Pakistan
facility: Jinnah Post graduate Medical Centre
state: Sindh
Study officials:
affiliation: Jinnah Post Graduate and Medical Centre
name: Shamim Kausar, EDIC,FCPS
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kashani K, Omer T, Shaw AD. The Intensivist's Perspective of Shock, Volume Management, and Hemodynamic Monitoring. Clin J Am Soc Nephrol. 2022 May;17(5):706-716. doi: 10.2215/CJN.14191021. Epub 2022 Apr 4.
citation: Basmaji J, Arntfield R, Desai K, Lau VI, Lewis K, Rochwerg B, Fiorini K, Honarmand K, Slessarev M, Leligdowicz A, Park B, Prager R, Wong MYS, Jones PM, Ball IM, Orozco N, Meade M, Thabane L, Guyatt G. The Impact of Point-of-Care Ultrasound-Guided Resuscitation on Clinical Outcomes in Patients With Shock: A Systematic Review and Meta-Analysis. Crit Care Med. 2024 Nov 1;52(11):1661-1673. doi: 10.1097/CCM.0000000000006399. Epub 2024 Sep 18.
citation: Musikatavorn K, Plitawanon P, Lumlertgul S, Narajeenron K, Rojanasarntikul D, Tarapan T, Saoraya J. Randomized Controlled Trial of Ultrasound-guided Fluid Resuscitation of Sepsis-Induced Hypoperfusion and Septic Shock. West J Emerg Med. 2021 Feb 10;22(2):369-378. doi: 10.5811/westjem.2020.11.48571.
citation: Spiliotaki E, Saranteas T, Moschovaki N, Panagouli K, Pistioli E, Kitsinelis V, Briasoulis P, Papadimos T. Inferior vena cava ultrasonography in the assessment of intravascular volume status and fluid responsiveness in the emergency department and intensive care unit: A critical analysis review. J Clin Ultrasound. 2022 Jun;50(5):733-744. doi: 10.1002/jcu.23194. Epub 2022 Mar 18.
citation: Kaptein EM, Kaptein MJ. Inferior vena cava ultrasound and other techniques for assessment of intravascular and extravascular volume: an update. Clin Kidney J. 2023 Jun 29;16(11):1861-1877. doi: 10.1093/ckj/sfad156. eCollection 2023 Nov.