An observational study in Cardiovascular Diseases, Acute Coronary Syndrome and Heart Failure, sponsored by Indonesia University. Completed at 9 sites in Indonesia. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-02-20.
Sponsored by Indonesia University · Observational
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.
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.
3,840 studies on the registry are indexed under Kidney Diseases; 500 are open to participants now.
This study's enrollment of 12,950 is above the median of 192 across 1,033 observational studies indexed under Kidney Diseases.
Browse Kidney Diseases studies →Indonesia University is the lead sponsor of 448 studies on the registry; 56 are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 1 (17%) have results posted.
Counted across the registry records on this site, refreshed daily.
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.
Exclusion Criteria:
The cohort was observed receiving all the necessary treatment in the ICCU.
Alive
Patient alive after being treated in ICCU.
Time frame: 1 to 30 days
Death
Patient death after being treated in ICCU.
Time frame: 1 to 30 days
Readmitted to ICCU
If a patient is readmitted to the ICCU after being transferred to a regular ward.
Time frame: 1 to 30 days
Rehospitalization
Readmission to the hospital within 30 days of discharge after treatment.
Time frame: 1 to 30 days
Plan to share: No
This study is completed, as verified in Feb 2024. You cannot join it, but the record below documents what was studied.
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Indonesia University