| CTRI Number |
CTRI/2024/12/078273 [Registered on: 18/12/2024] Trial Registered Prospectively |
| Last Modified On: |
21/10/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Using simple Calculations to predict Kidney Damage in Seriously Ill ICU Patients |
|
Scientific Title of Study
|
A Prospective Observational Study To Analyse The Efficacy Of RENAL ANGINA INDEX In Predicting The Course Of ACUTE KIDNEY INJURY In Critically Ill Adult 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 |
Dr Preethi Rajsri Anandhan |
| Designation |
DrNB Resident |
| Affiliation |
Meenakshi Mission Hospital & Research Centre |
| Address |
Department of Critical Care Medicine and Toxicology , Meenakshi Mission Hospital & Research Centre , Lake Area , Melur Road , Madurai
Madurai
TAMIL NADU
625107
India |
| Phone |
09943720201 |
| Fax |
|
| Email |
g5preeths@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr K S Anand |
| Designation |
Head Of Department |
| Affiliation |
Meenakshi Mission Hospital & Research Centre |
| Address |
Department of Critical Care Medicine and Toxicology , Meenakshi Mission Hospital & Research Centre , Lake Area , Melur Road , Madurai
Madurai
TAMIL NADU
625107
India |
| Phone |
9943720201 |
| Fax |
|
| Email |
anand2000xx@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr K S Anand |
| Designation |
Head Of Department |
| Affiliation |
Meenakshi Mission Hospital & Research Centre |
| Address |
Department of Critical Care Medicine and Toxicology , Meenakshi Mission Hospital & Research Centre , Lake Area , Melur Road , Madurai
Madurai
TAMIL NADU
625107
India |
| Phone |
9943720201 |
| Fax |
|
| Email |
anand2000xx@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Critical Care Medicine and Toxicology , Meenakshi Mission Hospital & Research Centre , Lake Area , Melur Road , Madurai |
|
|
Primary Sponsor
|
| Name |
MEENAKSHI MISSION HOSPITAL AND RESEARCH CENTRE |
| Address |
LAKE AREA , MELUR ROAD , MADURAI 625107 |
| 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 Preethi Rajsri Anandhan |
Meenakshi Mission Hospital & Research Centre |
Department of Critical Care Medicine and Toxicology , Meenakshi Mission Hospital & Research Centre , Lake Area , Melur Road , Madurai
Madurai
TAMIL NADU |
9943720201
g5preeths@GMAIL.COM |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE , MEENAKSHI MISSION HOSPITAL AND RESEARCH CENTRE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N179||Acute kidney failure, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
Patient admitted to ICU for more than 24 hours |
|
| ExclusionCriteria |
| Details |
Presence of AKI on admission
Serum Creatinine more than 2.5mg/dl on admission
Patients already on Renal Replacement Therapy
Chronic Kidney Disease
History of Kidney Transplantation
Pregnant patient
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Use of Renal Angina Index to predict the course of Acute Kidney Injury |
Day 0,1,3,7 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Analysing the Role of Renal Angina Index in predicting progression to Acute Kidney Disease and requirement of Renal Replacement Therapy
To study the correlation between Renal Angina Index Value and stage of AKI as per KDIGO guidelines |
Day 0,1,3,7 |
|
|
Target Sample Size
|
Total Sample Size="120"
Sample Size from India="120"
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)
|
01/01/2025 |
| 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="1"
Months="2"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
AKI can increase the risk of Chronic Kidney Disease
through a number of mechanisms that lead to tubulointerstitial damage and
fibrosis. Hence Timely Diagnosis and Timely management can save the
nephrons from going for a irreversible injury leading to Chronic Kidney Disease. Recently,
the Renal angina index (RAI), which is determined based on changes in renal
function, was proposed to risk stratify critically ill children at high risk of
AKI.The concept of renal angina has come into use to highlight the
characteristics of renal injury as an analogy to the concept of angina
pectoris, which is used to increase the suspicion of acute coronary syndrome in
cardiology. The RAI is assumed to serve as a potential biomarker
for detecting early signs of persistent AKI for 1 week. The RAI in
adults was proposed.In our study
we want to analyse the efficacy of Renal Angina Index in early prediction of
AKI , so that Nephroprotective measures can be initiated early to prevent the
further Renal injury. In our Study , we have hypothesized that Renal Angina
Index more than 8 does not correlate with Acute Kidney Injury in critically ill
adult patients. |