| CTRI Number |
CTRI/2024/11/077402 [Registered on: 27/11/2024] Trial Registered Prospectively |
| Last Modified On: |
09/11/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Prospective observational |
| Study Design |
Other |
|
Public Title of Study
|
Using APACHE II Score to predict ICU outcome of patient with chronic kidney diseases. |
|
Scientific Title of Study
|
Predicting outcome of intensive care unit patients with chronic kidney diseases using Acute physiology and chronic health evaluation II Score. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sneha Joice Rachel I |
| Designation |
Post Graduate student |
| Affiliation |
Sri Ramachandra Institute of Higher Education and Research |
| Address |
Department of Critical Care Medicine M.SC Critical Care Technology
Sri Ramachandra Institute of Higher Education And Research Porur .
Chennai 600116 .
Thiruvallur
TAMIL NADU
600116
India |
| Phone |
6382767684 |
| Fax |
|
| Email |
joicerachel21@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Hemalatha RV |
| Designation |
Assistant professor |
| Affiliation |
Sri Ramachandra Institute of Higher Education and Research |
| Address |
Department of Critical Care Medicine M.SC Critical Care Technology
Sri Ramachandra Institute of Higher Education And Research Porur .
Chennai 600116 .
Thiruvallur
TAMIL NADU
600116
India |
| Phone |
9552960709 |
| Fax |
|
| Email |
hema.rvasu@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Renuka MK |
| Designation |
Professor and Head of Department |
| Affiliation |
Sri Ramachandra Institute of Higher Education and Research |
| Address |
Department of Critical Care Medicine M.SC Critical Care Technology
Sri Ramachandra Institute of Higher Education And Research Porur .
Chennai 600116 .
Thiruvallur
TAMIL NADU
600116
India |
| Phone |
8056126336 |
| Fax |
|
| Email |
renuka.mk@sriramachandra.edu.in |
|
|
Source of Monetary or Material Support
|
| Sri Ramachandra Institute of Higher Education and Research Department of critical care medicine , porur , chennai, Tamil nadu, India - 600116 |
|
|
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, Tamilnadu,
India - 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 Hemalatha RV |
Sri Ramachandra Institute of Higher Education And Research |
Department of Critical Care Medicine Sri Ramachandra Institute of Higher Education And Research, Porur, Chennai, Tamilnadu, India - 600116
Thiruvallur
TAMIL NADU |
9952960709
hema.rvasu@gmail.com |
|
|
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: N18||Chronic kidney disease (CKD), (2) ICD-10 Condition: N189||Chronic kidney disease, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
All adult chronic kidney disease patients with or without irrespective of dialysis status in intensive care unit.
Patient above 18 years of age admitted to Intensive care unit.
|
|
| ExclusionCriteria |
| Details |
Patient who underwent renal transplantation or nephrectomy admitted to Intensive care unit.
Known case of acute kidney injury patients in Intensive care unit.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The primary outcome is to assess the association of APACHE II score as a predictor of mortality in critically ill Chronic kidney diseases patients. |
six months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To assess the relationship between admission in APACHE II and length of ICU stay in chronic kidney diseases in patient.
To assess the correlation between trend of APACHE II with mortality. |
six months |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
02/12/2024 |
| 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 ( APACHE ) II severity score has shown a good calibration and discriminatory value across a range of diseases processes and remains the most widely used source of prognostic information on the risk for death in patients admitted to intensive care units (ICUs). |