NCT06265714

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12,950

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2021

Typical duration for all trials

Geographic Reach
1 country

9 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 23, 2021

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 6, 2023

Completed
17 days until next milestone

Study Completion

Last participant's last visit for all outcomes

September 23, 2023

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

February 10, 2024

Completed
10 days until next milestone

First Posted

Study publicly available on registry

February 20, 2024

Completed
Last Updated

February 20, 2024

Status Verified

February 1, 2024

Enrollment Period

2.1 years

First QC Date

February 10, 2024

Last Update Submit

February 17, 2024

Conditions

Outcome Measures

Primary Outcomes (4)

  • Alive

    Patient alive after being treated in ICCU.

    1 to 30 days

  • Death

    Patient death after being treated in ICCU.

    1 to 30 days

  • Readmitted to ICCU

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

    1 to 30 days

  • Rehospitalization

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

    1 to 30 days

Study Arms (1)

One ICCU Registry

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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • Patients admitted to the ICCU
  • Aged 18 years or older
  • Provide consent to participate in the study

You may not qualify if:

  • \- Postoperative management following cardiac surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

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

Denpasar, Bali, Indonesia

Location

Dr. Kariadi General Hospital

Semarang, Central Java, Indonesia

Location

Dr. Saiful Anwar General Hospital

Malang, East Java, Indonesia

Location

Dr. Iskak General Hospital

Tulungagung, East Java, Indonesia

Location

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

Manado, North Sulawesi, Indonesia

Location

Dr. Wahidin Sudirohusodo General Hospital

Makassar, South Sulawesi, Indonesia

Location

Dr. M. Djamil Padang General Hospital

Padang, West Sumatra, Indonesia

Location

National Cardiovacular Center Harapan Kita

Jakarta, Indonesia

Location

Sardjito General Hospital

Yogyakarta, Indonesia

Location

Related 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.

    PMID: 36029517BACKGROUND

MeSH Terms

Conditions

Cardiovascular DiseasesAcute Coronary SyndromeHeart FailureCoronary DiseaseInfectionsSepsisStrokeShockRenal Insufficiency, Chronic

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesVascular DiseasesSystemic Inflammatory Response SyndromeInflammationPathologic ProcessesPathological Conditions, Signs and SymptomsCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesRenal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease Attributes

Study Officials

  • Dafsah Juzar, MD

    Indonesia University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
1 Month
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD, FIHA, FAsCC, FESC, FAPSIC, FSCAI

Study Record Dates

First Submitted

February 10, 2024

First Posted

February 20, 2024

Study Start

July 23, 2021

Primary Completion

September 6, 2023

Study Completion

September 23, 2023

Last Updated

February 20, 2024

Record last verified: 2024-02

Data Sharing

IPD Sharing
Will not share

Locations