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

NCT ID: NCT06265714

Last Updated: 2024-02-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

12950 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-07-23

Study Completion Date

2023-09-23

Brief Summary

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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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Detailed Description

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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.

Conditions

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

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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One ICCU Registry

The cohort was observed receiving all the necessary treatment in the ICCU.

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Indonesia University

OTHER

Sponsor Role lead

Responsible Party

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Dafsah A. Juzar, MD

MD, PhD, FIHA, FAsCC, FESC, FAPSIC, FSCAI

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Dafsah Juzar, MD

Role: PRINCIPAL_INVESTIGATOR

Indonesia University

Locations

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Prof. dr. I.G.N.G. Ngoerah General Hospital

Denpasar, Bali, Indonesia

Site Status

Dr. Kariadi General Hospital

Semarang, Central Java, Indonesia

Site Status

Dr. Saiful Anwar General Hospital

Malang, East Java, Indonesia

Site Status

Dr. Iskak General Hospital

Tulungagung, East Java, Indonesia

Site Status

Prof. Dr. R. D. Kandou Manado General Hospital

Manado, North Sulawesi, Indonesia

Site Status

Dr. Wahidin Sudirohusodo General Hospital

Makassar, South Sulawesi, Indonesia

Site Status

Dr. M. Djamil Padang General Hospital

Padang, West Sumatra, Indonesia

Site Status

National Cardiovacular Center Harapan Kita

Jakarta, , Indonesia

Site Status

Sardjito General Hospital

Yogyakarta, , Indonesia

Site Status

Countries

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Indonesia

References

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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.

Reference Type BACKGROUND
PMID: 36029517 (View on PubMed)

Other Identifiers

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LB.02.01/VII/005/KEP005/2022

Identifier Type: -

Identifier Source: org_study_id

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