| CTRI Number |
CTRI/2024/11/077234 [Registered on: 22/11/2024] Trial Registered Prospectively |
| Last Modified On: |
22/11/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Prospective |
| Study Design |
Other |
|
Public Title of Study
|
The reliability of the measurement of how well blood flows through the kidneys to predict acute kidney injury in a population of ICU patients |
|
Scientific Title of Study
|
Renal resistive index as an early predictor of acute kidney injury in a general ICU cohort: A prospective observational study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Version 4.0 dated 30/04/2024 |
Other |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sasidhar Datla |
| Designation |
DrNB Critical Care Medicine Resident |
| Affiliation |
Narayana Health |
| Address |
Mazumdar Shaw Medical Centre, Medical Intensive Care Unit, 2nd Floor, Narayana Health City, Bommasandra
Bangalore
KARNATAKA
560099
India |
| Phone |
9866766987 |
| Fax |
|
| Email |
drsasidhardatla@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Arjun Alva |
| Designation |
Senior Consultant, Critical Care Medicine |
| Affiliation |
Narayana Health |
| Address |
Mazumdar Shaw Medical Centre, Medical Intensive Care Unit, 2nd Floor, Narayana Health City, Bommasandra, Bengaluru.
Bangalore
KARNATAKA
560099
India |
| Phone |
9108026001 |
| Fax |
|
| Email |
arjun.alva.dr@narayanahealth.org |
|
Details of Contact Person
Public Query
|
| Name |
Dr Arjun Alva |
| Designation |
Senior Consultant, Critical Care Medicine |
| Affiliation |
Narayana Health |
| Address |
Mazumdar Shaw Medical Centre, Medical Intensive Care Unit, 2nd Floor, Narayana Health City, Bommasandra, Bengaluru.
Bangalore
KARNATAKA
560099
India |
| Phone |
9108026001 |
| Fax |
|
| Email |
arjun.alva.dr@narayanahealth.org |
|
|
Source of Monetary or Material Support
|
| Mazumdar Shaw Medical Centre, Medical Intensive Care Unit, 2nd Floor, Narayana Health City, Bommasandra, Bengaluru ,India , 560099 |
|
|
Primary Sponsor
|
| Name |
Dr Sasidhar Datla |
| Address |
Mazumdar Shaw Medical Centre, Medical Intensive Care Unit, 2nd Floor, Narayana Health City, Bommasandra, Bengaluru ,India , 560099 |
| Type of Sponsor |
Other [Self] |
|
|
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 Sasidhar Datla |
Mazumdar Shaw Medical Centre |
Medical Intensive Care Unit, 2nd Floor, Dept of Critical Care,Narayana Health City, Bommasandra
Bangalore
KARNATAKA |
9866766987
drsasidhardatla@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Narayana Health Academic Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: R69||Illness, unspecified, |
|
|
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. Critically ill patients aged 18 years or older admitted to the ICU with a predicted length of stay exceeding 24 hours and no baseline AKI. |
|
| ExclusionCriteria |
| Details |
1. Pre-existing chronic kidney disease, known renal artery stenosis, pregnancy.
2. Post cardiac arrest resuscitated patients. poor abdominal echogenicity, severe acute or chronic renal insufficiency defined as eGFR less than 30 ml/min/ 1.73m2, dialysis dependency, renal transplantation, mono-kidney, kidney tumour, anatomic kidney abnormalities.
3. Discharged within 24hrs. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To derive an association between RENAL RESISTIVITY INDEX and incidence of AKI |
Day 0 (Baseline), Day 1 (24-48 hours), Day 2 (48-72 hours) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To Evaluate the predictive performance of RRI compared to conventional AKI diagnostic methods (serum creatinine, urine output). |
Day 0 (Baseline), Day 1 (24-48 hours), Day 2 (48-72 hours) |
| To Identify the optimal cut-off value of RRI for AKI prediction. |
Day 0 (Baseline), Day 1 (24-48 hours), Day 2 (48-72 hours) |
| To Assess the relationship between RRI & AKI severity & mortality. |
Day 0 (Baseline), Day 1 (24-48 hours), Day 2 (48-72 hours) |
|
|
Target Sample Size
|
Total Sample Size="76"
Sample Size from India="76"
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)
|
06/12/2024 |
| 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 Yet Recruiting |
| 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
|
Acute kidney injury (AKI) occurs in 30 to 57% of critically ill intensive care patients. In its severe form, AKI requires renal replacement therapy, which is applied in 5–13% of ICU patients. Since AKI increases morbidity and mortality, early detection and prevention are crucial to improve the patient outcomes. However, early detection of AKI requires markers of early kidney injury that are sensitive and easily applicable in clinical practice. The diagnosis of AKI is routinely based on increased serum creatinine (SCr) and urea, as well as functional parameters, such as oliguria.
Renal vasoconstriction is an early manifestation of AKI. Determination of the renal resistive index (RRI) by Doppler sonography has also been suggested as a means of diagnosing AKI. Renal Doppler ultrasound can measure the renal resistive index (RRI), a sonographic index that reflects alterations in blood flow profile of the intrarenal arcuate or interlobar arteries.
This prospective study is aimed to analyse Renal resistivity index as an early predictor of AKI in our ICU cohort.
|