| 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
|
|
|
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
|
|
|
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. |