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

February 17, 2024 updated by: Dafsah A. Juzar, MD, Indonesia University
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.

Study Overview

Status

Completed

Conditions

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.

Study Type

Observational

Enrollment (Actual)

12950

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
One ICCU Registry
The cohort was observed receiving all the necessary treatment in the ICCU.

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Indonesia University

Investigators

  • Principal Investigator: Dafsah Juzar, MD, Indonesia University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 23, 2021

Primary Completion (Actual)

September 6, 2023

Study Completion (Actual)

September 23, 2023

Study Registration Dates

First Submitted

February 10, 2024

First Submitted That Met QC Criteria

February 10, 2024

First Posted (Actual)

February 20, 2024

Study Record Updates

Last Update Posted (Actual)

February 20, 2024

Last Update Submitted That Met QC Criteria

February 17, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LB.02.01/VII/005/KEP005/2022

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Cardiovascular Diseases

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in United States

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe