The IndONEsia ICCU Registry: a Multicenter Cohort of Intensive Cardiovascular Care Units Patients in Indonesia

Stroke Clinical Trial

Official title:

The IndONEsia ICCU Registry: a Multicenter Cohort of Intensive Cardiovascular Care Units Patients in Indonesia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06265714
• Other study ID #: LB.02.01/VII/005/KEP005/2022
• Status: Completed
• Start date: July 23, 2021
• Est. completion date: September 23, 2023

Study information

• Verified date: February 2024
• Source: Indonesia University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12950
• Est. completion date: September 23, 2023
• Est. primary completion date: September 6, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Coronary Syndrome
• Cardiovascular Diseases
• Chronic Kidney Diseases
• Coronary Disease
• Heart Disease, Coronary
• Heart Diseases
• Heart Failure
• Infections
• Kidney Diseases
• Renal Insufficiency, Chronic
• Sepsis
• Shock
• Stroke

Locations

Country	Name	City	State
Indonesia	Prof. dr. I.G.N.G. Ngoerah General Hospital	Denpasar	Bali
Indonesia	National Cardiovacular Center Harapan Kita	Jakarta
Indonesia	Dr. Wahidin Sudirohusodo General Hospital	Makassar	South Sulawesi
Indonesia	Dr. Saiful Anwar General Hospital	Malang	East Java
Indonesia	Prof. Dr. R. D. Kandou Manado General Hospital	Manado	North Sulawesi
Indonesia	Dr. M. Djamil Padang General Hospital	Padang	West Sumatra
Indonesia	Dr. Kariadi General Hospital	Semarang	Central Java
Indonesia	Dr. Iskak General Hospital	Tulung Agung	East Java
Indonesia	Sardjito General Hospital	Yogyakarta

Sponsors (1)

Lead Sponsor	Collaborator
Indonesia University

Country where clinical trial is conducted

Indonesia, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Alive	Patient alive after being treated in ICCU.	1 to 30 days
Primary	Death	Patient death after being treated in ICCU.	1 to 30 days
Primary	Readmitted to ICCU	If a patient is readmitted to the ICCU after being transferred to a regular ward.	1 to 30 days
Primary	Rehospitalization	Readmission to the hospital within 30 days of discharge after treatment.	1 to 30 days