| CTRI Number |
CTRI/2024/05/068229 [Registered on: 31/05/2024] Trial Registered Prospectively |
| Last Modified On: |
24/05/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Study of the ability of a test measuring the changes in blood flow to the kidneys to predict the recovery of kidney damage in patients in liver ICU |
|
Scientific Title of Study
|
Renal Resistivity Index as a predictor of acute kidney injury recovery in patient in liver ICU: a prospective 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 |
Sharika Sriramanan |
| Designation |
Fellow in Liver Transplant Anaesthesia and Critical Care |
| Affiliation |
Dr Rela Institute and Medical Centre |
| Address |
Department of Liver Transplant Anaesthesia and Critical Care, Third floor, Dr Rela Institute and Medical Centre, No 7, CLC Works Road, Chromepet, Chennai, Tamil Nadu
Chennai
TAMIL NADU
600044
India |
| Phone |
7760413236 |
| Fax |
|
| Email |
sharika.sriramanan@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Sharika Sriramanan |
| Designation |
Fellow in Liver Transplant Anaesthesia and Critical Care |
| Affiliation |
Dr Rela Institute and Medical Centre |
| Address |
Department of Liver Transplant Anaesthesia and Critical Care, Third floor, Dr Rela Institute and Medical Centre, No 7, CLC Works Road, Chromepet, Chennai, Tamil Nadu
Chennai
TAMIL NADU
600044
India |
| Phone |
7760413236 |
| Fax |
|
| Email |
sharika.sriramanan@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Sharika Sriramanan |
| Designation |
Fellow in Liver Transplant Anaesthesia and Critical Care |
| Affiliation |
Dr Rela Institute and Medical Centre |
| Address |
Department of Liver Transplant Anaesthesia and Critical Care, Third floor, Dr Rela Institute and Medical Centre, No 7, CLC Works Road, Chromepet, Chennai, Tamil Nadu
Chennai
TAMIL NADU
600044
India |
| Phone |
7760413236 |
| Fax |
|
| Email |
sharika.sriramanan@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr Rela Institute and Medical Centre
No 7, CLC Works Road, Chromepet, Chennai, Tanil Nadu, India - 600044 |
|
|
Primary Sponsor
|
| Name |
Dr Rela Institute and Medical Centre |
| Address |
No 7, CLC Works Road, Chromepet, Chennai, Tamil Nadu, India- 600044 |
| 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 Akila Rajakumar |
Dr Rela Institute and Medical Centre |
Department of Anaesthesia and Critical Care, Third Floor, Dr Rela Institute and Medical Centre, No 7, CLC Works Road, Chromepet, Chennai
Chennai
TAMIL NADU |
9840136295
drakila.rajakumar@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Dr Rela Institute and Medical Centre |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K74||Fibrosis and cirrhosis of liver, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Patients with cirrhosis admitted to Liver ICU with acute kidney injury
Male and female patients
Age less then 70
Age more than 18 |
|
| ExclusionCriteria |
| Details |
Patients with chronic kidney disease
Patient refusal |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To study the use of renal resistive index to predict the recovery of patients with acute kidney injury in cirrhotic patients in Liver ICU. |
Day of admission
Day 1 to 3 of treatment |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.To study use of NGAL to predict AKI recovery in Liver ICU
2.To study use of volume markers to predict AKI recovery in Liver ICU.
3.To analyse predictive ability of RRI in predicting ICU outcomes like days of mechanical ventilation, need for renal replacement therapy, length of hospital and ICU stay, 30 and 90 day mortality. |
Day of admission
Day 1 to 3 of treatment |
|
|
Target Sample Size
|
Total Sample Size="118"
Sample Size from India="118"
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)
|
16/07/2024 |
| 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
|
This is a prospective single arm observational study designed with 118 patients, of male and female genders, to investigate whether the Renal Resistive Index measured in a patient admitted to Liver ICU with acute kidney injury can predict the recovery of the same through the course of treatment.The Renal Resistive Index or RRI is a value derived from the ultrasound guided imaging of the arteries supplying the kidneys. This value was found to be increased in patients with acute kidney injury with the levels reducing with the recovery of the kidney injury.
In this study, the RRI value will be measured at the time of admission to ICU and the same will be followed up on day 1 through 3 of treatment. Other values and inputs such as the laboratory investigations of creatinine, volume status such as IVC measurement, Vti, biomarker levels such as NGAL will also be followed up during the course of treatment (Day 1 through 3).
Other details such as need for renal replacement therapy, mechanical ventilation, days of ICU and hospital stay, 30 and 90 day mortality will also be followed up. |