Clinical trial NCT06265714: The IndONEsia ICCU Registry: a Multicenter Cohort of Intensive Cardiovascular Care Units Patients in Indonesia
Official title: The IndONEsia ICCU Registry: a Multicenter Cohort of Intensive Cardiovascular Care Units Patients in Indonesia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cardiovascular Diseases
Acute Coronary Syndrome
Heart Failure
Heart Disease, Coronary
Infections
Sepsis
Stroke
Shock
Chronic Kidney Diseases
Lead sponsor: Indonesia University
Sponsor class: OTHER
First posted: 2024-02-20
Enrollment: 12950
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The inclusion criteria of this study include patients aged ≥ 18 years old who consent to participate in the study. We exclude admissions solely for postoperative management following cardiac surgery. Patients willing to participate in this study are followed up on their day three and five of in-ICCU care, their hospital discharge time, and day 30 following the day of their hospital discharge. Patients who were admitted to the ICCU and meet the inclusion criteria will be informed regarding the details of this study. In cases where patients cannot express their consent to participate in this study (e.g., those with loss of consciousness), informed consent may be obtained from the patients' guardians on their behalf.

Brief summary: Patients in the Intensive Cardiovascular Care Unit (ICCU) often present with cardiovascular disease (CVD) issues accompanied by various non-cardiovascular conditions. However, a widely applicable scoring system to predict patient outcomes in the ICCU is lacking. Therefore, developing and validating scores for predicting ICCU patient outcomes are warranted. The aims of the IndONEsia ICCU (One ICCU) registry include developing an epidemiological registry of ICCU patients and establishing a multicentre research network to analyse patient outcomes.This nationwide multicenter cohort will capture data from patients receiving cardiovascular critical care treatment in 10 Indonesian hospitals with ICCU facilities. Recorded data will encompass demographic characteristics, physical examination findings at hospital and ICCU admission, diagnoses at ICCU admission, therapy, intervention, complications on days 3 and 5 of in-ICCU care, in-hospital outcomes, and 30-day outcomes. The One ICCU is a large, prospective registry describing the care process and advancing clinical knowledge in ICCU patients. It will serve as an investigational platform for predicting the mortality of ICCU patients.

Detailed description: This prospective cohort registry study protocol comprised all consecutive primary medical ICCU admissions across one speciality hospital and nine general hospitals in Indonesia. The participating hospitals include the specialized National Cardiovascular Center Harapan Kita in Jakarta and nine general hospitals: Dr. Sardjito General Hospital in Yogyakarta, Dr. Wahidin Sudirohusodo General Hospital in Makassar, H. Adam Malik General Hospital in Medan, Dr. Saiful Anwar General Hospital in Malang, Dr. M. Djamil General Hospital in Padang, Dr. Iskak General Hospital in Tulungagung, Prof. Ngoerah General Hospital in Denpasar, Prof. Dr. R. D. Kandou General Hospital Manado, and Dr. Kariadi General Hospital Semarang. Each participating hospital will contribute data for all consecutive medical ICCU admissions for a period of 2 years, from 2021 to 2023. The participating hospitals were carefully selected to represent all regions of Indonesia.

Eligibility criteria: Inclusion Criteria:

* Patients admitted to the ICCU
* Aged 18 years or older
* Provide consent to participate in the study

Exclusion Criteria:

- Postoperative management following cardiac surgery

Primary outcomes:
measure: Alive
timeFrame: 1 to 30 days
measure: Death
timeFrame: 1 to 30 days
measure: Readmitted to ICCU
timeFrame: 1 to 30 days
measure: Rehospitalization
timeFrame: 1 to 30 days
Secondary outcomes:
Other outcomes:
Locations:
city: Denpasar
country: Indonesia
facility: Prof. dr. I.G.N.G. Ngoerah General Hospital
state: Bali
city: Semarang
country: Indonesia
facility: Dr. Kariadi General Hospital
state: Central Java
city: Malang
country: Indonesia
facility: Dr. Saiful Anwar General Hospital
state: East Java
city: Tulung Agung
country: Indonesia
facility: Dr. Iskak General Hospital
state: East Java
city: Manado
country: Indonesia
facility: Prof. Dr. R. D. Kandou Manado General Hospital
state: North Sulawesi
city: Makassar
country: Indonesia
facility: Dr. Wahidin Sudirohusodo General Hospital
state: South Sulawesi
city: Padang
country: Indonesia
facility: Dr. M. Djamil Padang General Hospital
state: West Sumatra
city: Jakarta
country: Indonesia
facility: National Cardiovacular Center Harapan Kita
city: Yogyakarta
country: Indonesia
facility: Sardjito General Hospital
Study officials:
affiliation: Indonesia University
name: Dafsah Juzar, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Metkus TS, Baird-Zars VM, Alfonso CE, Alviar CL, Barnett CF, Barsness GW, Berg DD, Bertic M, Bohula EA, Burke J, Burstein B, Chaudhry SP, Cooper HA, Daniels LB, Fordyce CB, Ghafghazi S, Goldfarb M, Katz JN, Keeley EC, Keller NM, Kenigsberg B, Kontos MC, Kwon Y, Lawler PR, Leibner E, Liu S, Menon V, Miller PE, Newby LK, O'Brien CG, Papolos AI, Pierce MJ, Prasad R, Pisani B, Potter BJ, Roswell RO, Sinha SS, Shah KS, Smith TD, Snell RJ, So D, Solomon MA, Ternus BW, Teuteberg JJ, van Diepen S, Zakaria S, Morrow DA. Critical Care Cardiology Trials Network (CCCTN): a cohort profile. Eur Heart J Qual Care Clin Outcomes. 2022 Oct 26;8(7):703-708. doi: 10.1093/ehjqcco/qcac055.