CTRI Number |
CTRI/2025/06/088973 [Registered on: 17/06/2025] Trial Registered Prospectively |
Last Modified On: |
16/06/2025 |
Post Graduate Thesis |
No |
Type of Trial |
Interventional |
Type of Study
|
Diagnostic Screening |
Study Design |
Randomized, Parallel Group Trial |
Public Title of Study
|
Ultrasound guided management of renal failure in Cirrhosis |
Scientific Title of Study
|
VExUS Assisted Management of Acute Kidney injury in Cirrhosis (VAMAS Study) |
Trial Acronym |
VAMAS |
Secondary IDs if Any
|
Secondary ID |
Identifier |
NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
Vineet Behera |
Designation |
Professor Medicine & Nephrologist |
Affiliation |
INHS Kalyani |
Address |
INHS Kalyani
Visakhapatnam ANDHRA PRADESH 430005 India |
Phone |
9673470724 |
Fax |
|
Email |
vineetbeheraaiims@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
Vineet Behera |
Designation |
Professor Medicine & Nephrologist |
Affiliation |
INHS Kalyani |
Address |
INHS Kalyani
ANDHRA PRADESH 430005 India |
Phone |
9673470724 |
Fax |
|
Email |
vineetbeheraaiims@gmail.com |
|
Details of Contact Person Public Query
|
Name |
Vineet Behera |
Designation |
Professor Medicine & Nephrologist |
Affiliation |
INHS Kalyani |
Address |
INHS Kalyani
ANDHRA PRADESH 430005 India |
Phone |
9673470724 |
Fax |
|
Email |
vineetbeheraaiims@gmail.com |
|
Source of Monetary or Material Support
|
|
Primary Sponsor
|
Name |
INHS Kalyani |
Address |
Malkapuram, Visakhapatnam, 530005 |
Type of Sponsor |
Other [Government 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 Vineet Behera |
Dept of Nephrology and Dialysis, INHS Kalyani |
Malkapuram Visakhapatnam ANDHRA PRADESH |
9673470724
vineetbeheraaiims@gmail.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
Institute of Naval Medicine, INHS |
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 |
Comparator Agent |
Conventional therapy |
Conventional fluid and hemodynamic management based on clinical judgement -
Standard clinical evaluation guides therapy without additional tools.
•Fluid resuscitation, diuretics, or vasopressors based on clinical judgement and response to therapy as assessed by clinician
|
Intervention |
POCUS Assisted Therapy |
POCUS Protocol Done for Volume characterization and congestion assessment (VeXUS)
i. Inferior Vena Cava (IVC): Measure diameter and collapsibility index to assess volume status.
ii. Lung Ultrasound (LUS): Evaluate B-lines for pulmonary congestion, pleural effusion by using abbreviated 8-zone protocol
iii. Venous Excess Ultrasound: Assess IVC and if IVC is plethoric then check femoral vein and internal jugular vein
iv. Focused Cardiac Ultrasound (FoCUS): Assess left ventricular systolic function.
v. IJV cross-sectional area and collapsibility measurement
vi. Kidney Ultrasound- To rule out obstruction, chronic kidney disease
|
|
Inclusion Criteria
|
Age From |
18.00 Year(s) |
Age To |
80.00 Year(s) |
Gender |
Both |
Details |
All patients of chronic liver disease (diagnosed by clinical, biochemical, imaging criteria) presenting with Acute kidney injury per KDIGO criteria |
|
ExclusionCriteria |
Details |
1.Established chronic kidney disease (as per KDIGO criteria) stage 3-5
2.Patients on dialysis
3.Patients on mechanical ventilator
4.Conditions in whom technically POCUS could not be done
5.Non Cooperative patient
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
Blinding/Masking
|
Open Label |
Primary Outcome
|
Outcome |
TimePoints |
1.Recovery of AKI (?20 % decrease ( partial recovery) in serum creatinine or return to baseline) by day 7
2.Duration in days to attain renal recovery ( return of creatinine level to partial or complete recovery)
|
7 days |
|
Secondary Outcome
|
Outcome |
TimePoints |
1.30-day mortality
2.Therapy adjustments (e.g., fluids, use of diuretic, Inj albumin, day of hospitalization terlipressin use) compared between groups
3.Length of hospitalization
|
Onset, 7 days, 30 days |
|
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
|
Phase 2/ Phase 3 |
Date of First Enrollment (India)
|
10/07/2025 |
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 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) in patients with cirrhosis
is commonly multifactorial. Both diagnosis and management in such cases can be
challenging. In many patients, a definitive diagnosis cannot be established
through patient history, physical examination, or standard laboratory tests,
especially when AKI has a hemodynamic origin, such as hepatorenal syndrome.
Current guidelines offer broad recommendations, including stopping diuretics
and administering albumin for 48 hours to expand plasma volume. However, these
approaches can sometimes be ineffective or even harmful, potentially leading to
complications like fluid overload and acute cardiogenic pulmonary edema. Given
these limitations, newer diagnostic tools like hemodynamic point-of-care
ultrasound (PoCUS) provide a more precise assessment of a patient’s volume
status. This technology enables a rapid, noninvasive, and personalized approach
to guiding medical treatment. |