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

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.

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Key information

Conditions

Cardiovascular Diseases Acute Coronary Syndrome Brain Diseases Central Nervous System Diseases Cerebrovascular Disorders Chronic Disease Chronic Kidney Diseases Coronary Disease Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Heart Disease, Coronary Heart Diseases Heart Failure Infections Inflammation Kidney Diseases Male Urogenital Diseases Myocardial Ischemia Nervous System Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Sepsis Shock Stroke Systemic Inflammatory Response Syndrome Urogenital Diseases Urologic Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Prof. dr. I.G.N.G. Ngoerah General Hospital, Denpasar, Bali, Indonesia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

Alive

Time frame: 1 to 30 days

Patient alive after being treated in ICCU.
Death

Time frame: 1 to 30 days

Patient death after being treated in ICCU.
Readmitted to ICCU

Time frame: 1 to 30 days

If a patient is readmitted to the ICCU after being transferred to a regular ward.
Rehospitalization

Time frame: 1 to 30 days

Readmission to the hospital within 30 days of discharge after treatment.

Sponsors and collaborators

Lead sponsor

Indonesia University

Other

Registry information

Important dates

Study start: 2021
Primary completion: 2023
Study completion: 2023
First posted: Feb 20, 2024
Registry last updated: Feb 20, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

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