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临床试验/NCT06265714
NCT06265714已完成不适用

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

Indonesia University9 个研究点 分布在 1 个国家目标入组 12,950 人开始时间: 2021年7月23日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
12,950
试验地点
9
主要终点
Alive

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

  • Postoperative management following cardiac surgery

结局指标

主要结局

Alive

时间窗: 1 to 30 days

Patient alive after being treated in ICCU.

Rehospitalization

时间窗: 1 to 30 days

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

Readmitted to ICCU

时间窗: 1 to 30 days

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

Death

时间窗: 1 to 30 days

Patient death after being treated in ICCU.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Dafsah A. Juzar, MD

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

Indonesia University

研究点 (9)

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