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CTRI Number  CTRI/2025/12/099606 [Registered on: 22/12/2025] Trial Registered Prospectively
Last Modified On: 19/12/2025
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Cohort Study 
Study Design  Other 
Public Title of Study   Apache 2 vs Apache 4 study 
Scientific Title of Study   Comparison of Apache II and Apache IV scores in predicting ICU mortality and clinical outcomes: A one-year prospective cohort study 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Karthavya Sasuveghatta Lingappa 
Designation  Consultant 
Affiliation  Prakriya hospitals 
Address  Metro Pillar No 500, 8th Mile, Tumkur road Service road Nagasandra, Havanur Layout, Bagalakunte, Bengaluru, Karnataka

Bangalore
KARNATAKA
560073
India 
Phone  919972800191  
Fax    
Email  karthavyapractise@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Karthavya Sasuveghatta Lingappa 
Designation  Consultant 
Affiliation  Prakriya hospitals 
Address  Metro Pillar No 500, 8th Mile, Tumkur road Service road Nagasandra, Havanur Layout, Bagalakunte, Bengaluru, Karnataka


KARNATAKA
560073
India 
Phone  919972800191  
Fax    
Email  karthavyapractise@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Karthavya Sasuveghatta Lingappa 
Designation  Consultant 
Affiliation  Prakriya hospitals 
Address  Metro Pillar No 500, 8th Mile, Tumkur road Service road Nagasandra, Havanur Layout, Bagalakunte, Bengaluru, Karnataka


KARNATAKA
560073
India 
Phone  919972800191  
Fax    
Email  karthavyapractise@gmail.com  
 
Source of Monetary or Material Support  
Prakriya Hospitals, Metro Pillar No 500, 8th Mile, Tumkur road Service road Nagasandra, Havanur Layout, Bagalakunte, Bengaluru, Karnataka 560073 
 
Primary Sponsor  
Name  PRAKRIYA HOSPITALS 
Address  Metro Pillar No 500, 8th Mile, Tumkur road Service road Nagasandra, Havanur Layout, Bagalakunte, Bengaluru, Karnataka 560073 
Type of Sponsor  Private hospital/clinic 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Karthavya Sasuveghatta Lingappa  Prakriya hospitals  Metro Pillar No 500, 8th Mile, Tumkur road Service road Nagasandra, Havanur Layout, Bagalakunte, Bengaluru, Karnataka 560073
Bangalore
KARNATAKA 
919972800191

karthavyapractise@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
PRAKRIYA HOSPITALS INSTITUTIONAL ETHICS COMMITTEE  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: R652||Severe sepsis,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nil  Nil 
Comparator Agent  Nil  Nil 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  1. Age more or equal to 18 years.
2. All ICU admissions during the study period.
3. Availability of clinical/physiological data within the first 24 hours of ICU admission to calculate APACHE II and APACHE IV.
 
 
ExclusionCriteria 
Details  1. Admissions for palliative or comfort only care at entry (active DNAR with comfort only orders).
2. Refusal/withdrawal of consent (if consent model requires explicit consent).
3. Major data gaps rendering APACHE computation impossible despite prospective capture (e.g., more than 20 percent critical variables missing).
4. Extreme outliers (e.g., ICU stay more than 60 days) for sensitivity analyses; primary analysis will retain all unless clearly erroneous.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
ICU mortality  1 year 
 
Secondary Outcome  
Outcome  TimePoints 
length of ICU stay (days), duration of mechanical ventilation (hours), vasopressor use (yes/no, duration), renal replacement therapy (yes/no)  1 year 
 
Target Sample Size   Total Sample Size="1200"
Sample Size from India="1200" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   01/01/2026 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

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.

 
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