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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  
INHS Kalyani 
NIL 
 
Primary Sponsor  
Name  INHS Kalyani 
Address  Malkapuram, Visakhapatnam, 530005 
Type of Sponsor  Other [Government hospital] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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.

 
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