| CTRI Number |
CTRI/2025/08/092980 [Registered on: 13/08/2025] Trial Registered Prospectively |
| Last Modified On: |
11/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Difference among measurements taken by different person in renal resistive index {its a noninvasive measurement that assesses the resistance to blood flow in the renal arteries} |
|
Scientific Title of Study
|
Inter and intra-observer variablility of renal resistive index measurements in critically ill patients – a blinded observational study |
| 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 Ramapriya Sukumaran |
| Designation |
Post graduate DrNB critical care |
| Affiliation |
Kauvery hospital, |
| Address |
Critical care department
KAUVERY HOSPITAL
81, TTK Road Junction, CIT Colony, Alwarpet, Chennai, Tamil Nadu
Chennai
TAMIL NADU
600018
India |
| Phone |
04440006000 |
| Fax |
|
| Email |
ramapriyasukumaran@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vetriselvan P |
| Designation |
Consultant Critical Care |
| Affiliation |
Kauvery hospital, |
| Address |
Department of Critical care Kauvery Hospital
81, TTK Road Junction, CIT Colony, Alwarpet, Chennai, Tamil Nadu
Chennai
TAMIL NADU
600018
India |
| Phone |
04440006000 |
| Fax |
|
| Email |
castro.vetri6@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ramapriya Sukumaran |
| Designation |
Post graduate DrNB critical care |
| Affiliation |
Kauvery hospital, |
| Address |
Department of Critical care Medicine
Kauvery Hospital
81, TTK Road Junction, CIT Colony, Alwarpet, Chennai, Tamil Nadu
Chennai
TAMIL NADU
600018
India |
| Phone |
04440006000 |
| Fax |
|
| Email |
ramapriyasukumaran@yahoo.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dr Ramapriya Sukumaran |
| Address |
Department of Critical care Kauvery Hospital Chennai
81, TTK Road Junction, CIT Colony, Alwarpet, Chennai, Tamil Nadu 600018 |
| Type of Sponsor |
Private hospital/clinic |
|
|
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 Ramapriya Sukumaran |
Kauvery hospital |
Department of Critical care Kauvery Hospital
81, TTK Road Junction, CIT Colony, Alwarpet, Chennai, Tamil Nadu 600018
Chennai
TAMIL NADU |
9940987570
ramapriyasukumaran@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kauvery institutional 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 |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
With or without AKI |
|
| ExclusionCriteria |
| Details |
1.Poor abdominal echogenicity,
2.Severe acute or chronic renal insufficiency defined as eGFR lesser than 30 ml/min/ 1.73m2,
3.Dialysis dependency,
4.Renal transplantation,
5.known renal artery stenosis
6.pregnancy,
7.single-kidney, kidney tumor, anatomic kidney abnormalities,
8.Increased intraabdominal pressure, peripheral vascular disease.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare RRI measurements of non-expert sonographers (intensivist and novice) to that of expert (sonographer) for interobserver variability and intra -observer variability. |
To compare RRI measurements of non-expert sonographers (intensivist and novice) to that of expert (sonographer) for interobserver variability and intra -observer variability. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To evaluate whether RRI on day 1 of admission can predict development of AKI in critically ill patients.
To evaluate association of RRI with transient or persistent AKI. |
|
|
|
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)
|
22/08/2025 |
| 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
|
Renal resistive index can be measured using pulsed wave Doppler-USG. It is a rapid and non-invasive tool to detect resistance to arterial blood flow at interlobar and arcuate arteries resulting in renal hypoperfusion. RRI measurements need to be obtained by the clinician present at the bedside who may not always be an US expert. It is important to evaluate accuracy, reliability, interobserver variability, bias and precision. In previous studies, the study population consisted only of volunteers, and results may not necessarily be transferred to all other hospitalized populations such as ICU patients.
|