跳至主要内容
临床试验/CTRI/2025/12/099606
CTRI/2025/12/099606尚未招募不适用

Comparison of Apache II and Apache IV scores in predicting ICU mortality and clinical outcomes: A one-year prospective cohort study

PRAKRIYA HOSPITALS1 个研究点 分布在 1 个国家目标入组 1,200 人开始时间: 2026年1月1日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
1,200
试验地点
1

研究概览

简要总结

This study is a one year prospective observational cohort study designed to compare the performance of APACHE II and APACHE IV severity scoring systems in predicting ICU mortality and key clinical outcomes in adult critically ill patients. Accurate risk stratification is central to ICU benchmarking, prognostication, and resource allocation, yet the applicability of widely used scoring systems varies across populations and healthcare settings. While APACHE II remains extensively used due to its simplicity, APACHE IV incorporates updated physiological variables, diagnostic categories, and predictions for both mortality and ICU length of stay, potentially offering improved prognostic accuracy. However, evidence from Indian ICUs has shown inconsistent calibration and discrimination of these models, underscoring the need for local validation.

All consecutive adult patients (equal or more than 18 years) admitted to the adult intensive care unit of a tertiary care hospital over a 12 month period will be enrolled. Demographic data, comorbidities, admission characteristics, and physiological and laboratory parameters required to calculate APACHE II and APACHE IV scores will be prospectively collected within the first 24 hours of ICU admission using standardized case report forms. Patients admitted solely for comfort-focused or end of life care at entry will be excluded.

The primary outcome is ICU mortality. Secondary outcomes include ICU length of stay, requirement and duration of mechanical ventilation, vasopressor support, and renal replacement therapy. The predictive performance of APACHE II and APACHE IV will be evaluated using measures of discrimination (area under the receiver operating characteristic curve) and calibration (calibration plots, calibration-in-the-large, and goodness of fit testing). Comparative analyses between the two models will be performed using appropriate statistical methods for paired prognostic scores.

As a non-interventional study using routinely collected clinical data, this study poses minimal risk to participants and does not alter standard clinical care. The findings are expected to provide context specific evidence regarding the utility and limitations of APACHE II and APACHE IV in an Indian ICU setting, thereby informing clinical practice, quality benchmarking, and future model recalibration efforts.

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 99.00 Year(s)(—)
性别
All

入选标准

  • Age more or equal to 18 years.
  • All ICU admissions during the study period.
  • Availability of clinical/physiological data within the first 24 hours of ICU admission to calculate APACHE II and APACHE IV.

排除标准

  • Admissions for palliative or comfort only care at entry (active DNAR with comfort only orders).
  • Refusal/withdrawal of consent (if consent model requires explicit consent).
  • Major data gaps rendering APACHE computation impossible despite prospective capture (e.g., more than 20 percent critical variables missing).
  • Extreme outliers (e.g., ICU stay more than 60 days) for sensitivity analyses; primary analysis will retain all unless clearly erroneous.

研究者

发起方
PRAKRIYA HOSPITALS
申办方类型
Private hospital/clinic
责任方
Principal Investigator
主要研究者

Dr Karthavya Sasuveghatta Lingappa

Prakriya hospitals

研究点 (1)

Loading locations...

相似试验