| CTRI Number |
CTRI/2025/08/093183 [Registered on: 18/08/2025] Trial Registered Prospectively |
| Last Modified On: |
18/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Other |
|
Public Title of Study
|
Evaluating kidney functions in ICU patients with no kidney disease and its clinical outcomes. |
|
Scientific Title of Study
|
Incidence of augmented renal clearance and its effect on clinical outcomes of critically ill patients admitted in intensive care unit. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Meenakshi |
| Designation |
Junior resident |
| Affiliation |
Postgraduate Institute of Medical Education and Research,Chandigarh |
| Address |
Department of Anaesthesia and Intensive Care, Nehru Hospital,Postgraduate Institute of Medical Education and Research,Chandigarh.
Chandigarh
CHANDIGARH
160012
India |
| Phone |
9805136725 |
| Fax |
|
| Email |
bhatiameenakshi88@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Neeru Sahni |
| Designation |
Additional Professor |
| Affiliation |
Postgraduate Institute of Medical Education and Research,Chandigarh |
| Address |
Department of Anaesthesia and Intensive Care,Nehru Hospital,Postgraduate Institute of Medical Education and Research,Chandigarh.
Chandigarh
CHANDIGARH
160012
India |
| Phone |
9872646106 |
| Fax |
|
| Email |
neerunalin@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Neeru Sahni |
| Designation |
Additional Professor |
| Affiliation |
Postgraduate Institute of Medical Education and Research,Chandigarh |
| Address |
Department of Anaesthesia and Intensive Care,Nehru Hospital,Postgraduate Institute of Medical Education and Research,Chandigarh.
Chandigarh
CHANDIGARH
160012
India |
| Phone |
9872646106 |
| Fax |
|
| Email |
neerunalin@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Department of Anaesthesia,Nehru Hospital ,Level 4,Posgraduate Institute of Medical Education and Research ,Chandigarh ,India,160012 |
|
|
Primary Sponsor
|
| Name |
Postgraduate Institute of Medical Education and ResearchChandigarh |
| Address |
Department of Anaesthesia and Intensive Care,level 4,Nehru Hospital Block A,Chandigarh,160012 |
| 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 |
| Meenakshi |
Main ICU,Nehru Hospital,PGIMER |
Main ICU Nehru hospital Level 4,Postgraduate Institute of Medical Education And Research Chandigarh,India,160012
Chandigarh
CHANDIGARH |
09805136725
bhatiameenakshi88@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| POST GRADUATE INSTITUTE OF MEDICAL EDUCATION AND RESEARCH, CHANDIGARH. |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N08||Glomerular disorders in diseases classified elsewhere, |
|
|
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 |
All adult patients admitted to the Main ICU
1. Without AKI
2. AKI with KDIGO stage 1 or 2 at presentation will be enrolled (as KDIGO 1 and 2 are rapidly reversible forms of AKI).
|
|
| ExclusionCriteria |
| Details |
1. Patients with ICU stay less than 24 hours.
2. Patients with chronic kidney disease, with
or without RRT.
3. Patients with history of prolonged
immobilization, obstetric patients,
patients with evidence of rhabdomyolysis, AKI (KDIGO stage 3), patients who already received RRT prior to ICU admission.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Incidence of early (on admission) or late (5th day) ARC in critically ill adult patients |
On admission and 5th day. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. To correlate the CrCl measured using urine creatinine at 8-hour urine collection & serum creatinine with calculated CrCl using other methods:
Modified Cockgroft Gault formula, 4- variable Modification of Diet in Renal Disease (MDRD-4) equation & Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI).
2. Clinical outcomes in patients with ARC on admission (early) or late ARC (day 5) such as days of mechanical ventilation, requirement of vasopressor/inotrope, length of stay (LOS) in ICU & mortality.
3. Incidence of patients with ARC on admission developing acute kidney injury (AKI) with or without requirement of renal replacement therapy (RRT) during ICU stay, as defined by Kidney Disease: Improving Global Outcome (KDIGO) classification.
4. Factors affecting incidence of ARC.
|
At day 1,day 5 & day of discharge |
|
|
Target Sample Size
|
Total Sample Size="180"
Sample Size from India="180"
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)
|
29/09/2025 |
| 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="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
|
Primary purpose of this study is to evaluate the incidence of augmented renal clearance in critically ill patients admitted in main ICU as incidence of ARC is seen mostly in trauma patients and maximum studies are done in trauma ICU.This study will help to know about the clinical outcomes in patients exhibiting ARC on admission (early) or ARC on fifth day (late) of admission. Apart from this we will study about the factors affecting ARC and multiple outcomes like duration of mechanical ventilation,inotrope requirement, length of stay and mortality in ICU. |