| CTRI Number |
CTRI/2025/04/085533 [Registered on: 24/04/2025] Trial Registered Prospectively |
| Last Modified On: |
23/04/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) |
| Study Design |
Other |
|
Public Title of Study
|
Predicting mortality among critically ill patients in adult Intensive care unit using APACHE II and SOFA Scoring |
|
Scientific Title of Study
|
An observational prospective study using digital severity of illness scoring tools for comparing APACHE II and SOFA in adult ICU patients. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Vishwatha D R |
| Designation |
Post graduate student |
| Affiliation |
Sri Ramachandra Institute of Higher Education and Research |
| Address |
Department of Critical Care Medicine, Sri Ramachandra Institute of Higher Education and Research, Porur, Chennai 600116
Thiruvallur
TAMIL NADU
600116
India |
| Phone |
9884872509 |
| Fax |
|
| Email |
vishminnie@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Renuka MK |
| Designation |
Professor and head of the department |
| Affiliation |
Sri Ramachandra institute of higher education and research |
| Address |
Department of Critical Care Medicine, Sri Ramachandra Institute of Higher Education and Research, Porur, Chennai 600116
Thiruvallur
TAMIL NADU
600116
India |
| Phone |
8056126336 |
| Fax |
|
| Email |
renuka.mk@srimachandra.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Renuka MK |
| Designation |
Professor and head of the department |
| Affiliation |
Sri Ramachandra institute of higher education and research |
| Address |
Department of Critical Care Medicine, Sri Ramachandra Institute of Higher Education and Research, Porur, Chennai
Thiruvallur
TAMIL NADU
600116
India |
| Phone |
8056126336 |
| Fax |
|
| Email |
renuka.mk@srimachandra.edu.in |
|
|
Source of Monetary or Material Support
|
| Department of Critical Care Medicine, Sri Ramachandra Institute of Higher Education and Research, Porur, Chennai, Tamil Nadu-600116,India |
|
|
Primary Sponsor
|
| Name |
Sri Ramachandra institute of higher education and research |
| Address |
Department of Critical Care Medicine, Sri Ramachandra Institute of Higher Education and Research, Porur, Chennai 600116 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 MK Renuka |
Sri Ramachandra institute of higher education and research |
Department of Critical Care Medicine, Sri Ramachandra Institute of Higher Education and Research, Porur, Chennai 600116
Thiruvallur
TAMIL NADU |
8056126336
renuka.mk@sriramachandra.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| ETHICS COMMITTEE FOR STUDENTS PROJECTS |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: V00-Y99||External causes of morbidity, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
An Observational Prospective Study Using Digital Severity Of Illness Scoring Tools For Comparing APACHE II And SOFA In Adult ICU Patients. |
Predicting outcome of severity illness using digital scoring tools by Comparing Acute physiology and chronic health evaluation ( APACHE II) score and Sequential organ failure assessment (SOFA) score in adult intensive care unit (ICU). |
| Intervention |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
patients who are all taken for the study in adult intensive care unit (AFTER 48HOURS OF ADMISSION) |
|
| ExclusionCriteria |
| Details |
Patients below the age ground of 20 years
patients admitted in adult intensive care unit with in 48 hours |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Ensure patient safety and predicting their mortality using APACHE II scoring |
6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To assess the patients outcomes , predict mortality , length of stay in hospital |
6 months |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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)
|
04/05/2025 |
| 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="0"
Months="6"
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
|
 The Acute Physiology and chronic health evaluation II (APACHE II ) is a severity of disease scoring system that combines physiological data with information on age and comorbidity as well as diagnosis.The score can help in the assessment of patients to determine the level and degree of diagnostic and therapeutic intervention. Interpretation of Acute Physiology and chronic health evaluation II (APACHE II) minimum 0 and maximum 71 increasing score is associated with an increasing risk of hospital death.The Sequential Organ Failure Assessment (SOFA) score is a scoring system that assesses the performance of several organ systems in the body and assigns a score based on the data obtained in each category. Each organ system received a score ranging from 0 (normal) to 4 (most abnormal),with a minimum SOFA score of 0 and a maximum SOFA score of 24. In this study, comparing Acute physiology and chronic health evaluation (APACHE II) and Sequential organ failure assessment ( SOFA ) in critically ill patients in Intensive care unit ( ICU) to predict the mortality by entering data on admission after 48 hours and compare the details with APACHE II and SOFA scoring . |