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CTRI Number  CTRI/2022/10/046898 [Registered on: 28/10/2022] Trial Registered Prospectively
Last Modified On: 26/09/2023
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Biological 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Comparison between Standard medical therapy plus intravenous albumin vs standard medical therapy alone in patients with variceal upper gastrointestinal bleed. 
Scientific Title of Study   Standard medical therapy plus intravenous albumin vs standard medical therapy alone in patients with variceal upper gastrointestinal bleed: A randomized controlled trial 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Shalimar 
Designation  Additional Professor 
Affiliation  All India Institute of Medical Sciences 
Address  Room No. 127, first floor, Department of Gastroenterology and Human Nutrition unit
All Indian Institute of medical sciences, Ansari Nagar
South West
DELHI
110029
India 
Phone  9868397211  
Fax    
Email  drshalimar@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Shubam Mehta 
Designation  Senior Resident 
Affiliation  All India Institute of Medical Sciences 
Address  Department of Gastroenterology and Human Nutrition unit
All Indian Institute of medical sciences, Ansari Nagar
South West
DELHI
110029
India 
Phone  9871037814  
Fax    
Email  mehta.shubham1493@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Shubam Mehta 
Designation  Senior Resident 
Affiliation  All India Institute of Medical Sciences 
Address  Department of Gastroenterology and Human Nutrition unit
All Indian Institute of medical sciences, Ansari Nagar

DELHI
110029
India 
Phone    
Fax    
Email  mehta.shubham1493@gmail.com  
 
Source of Monetary or Material Support  
All India Institute of Medical Sciences 
 
Primary Sponsor  
Name  All India Institute of Medical Sciences 
Address  Department of Gastroenterology and Human Nutrition Unit, AIIMS, Ansari Nagar 
Type of Sponsor  Research institution and 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 Shalimar  All India Institute of Medical Sciences  Department of Gastroenterology and human Nutrition Unit, AIIMS,Ansari Nagar
South West
DELHI 		 9868397211

drshalimar@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institute Ethics Committee   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K746||Other and unspecified cirrhosis ofliver,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Standard Medical Therapy arm  All patients will receive volume resuscitation with crystalloids, antibiotic prophylaxis (inj ceftriaxone) and vasoactive drugs (Terlipressin, Somatostatin or Octreotide). A hemoglobin level of less than 7 g/dl will be the threshold for PRBC transfusion, which will be transfused to maintain a hemoglobin between 7-9 g/dl. 
Intervention  Standard medical therapy Plus albumin   In the SMT plus albumin group, intravenous albumin (100 ml, 20%, given at the rate of 10 ml/hr) would be started after measurement of HVPG of the endoscopic therapy. Albumin will be given at a cumulative dose of 2g/kg divided over 3 consecutive days. Human albumin, 20% 100ml solution, (FLEXBUMIN 20%, BAXALTA US Inc, IL, USA), each will be transfused at the rate of 10 ml per hour. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1. Patients with cirrhosis and variceal bleed presenting within 24 hours of bleed
2. Age 18-65 years
3. Willing to participate in the study
 
 
ExclusionCriteria 
Details  1. Patients with Child A cirrhosis
2. Patients with normal serum albumin
3. Patients undergoing pre-emptive TIPS
4. Patients with acute on chronic liver failure (diagnosed based on the EASL-CLIF criteria15) at presentation
5. Pregnancy
6. Hypersensitivity to albumin
7. Patients with hepatocellular cancer
8. Patients on anti-platelets or anticoagulants
9. Patients with other co-morbidities such as coronary artery disease, chronic obstructive pulmonary disease, chronic kidney disease and neuromuscular disorders
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Composite outcome of new-onset SBP, AKI, hepatic encephalopathy and all-cause mortality at 42 days in patients with cirrhosis and variceal bleed in the SMT vs SMT plus albumin group  42 days 
 
Secondary Outcome  
Outcome  TimePoints 
1. 5-day treatment failure rate
2. Need for salvage therapy [additional endoscopic therapy, transjugular intrahepatic portosystemic shunt (TIPS) or balloon retrograde transvenous occlusion (BRTO)]
3. Duration of hospital/ICU stay
4. Requirement of blood transfusion
5. Change in levels of tumour necrosis factor alpha (TNF-), interleukin-6 (IL-6), and endotoxin levels at day 3 in comparison to day 1
6. Change in HVPG at day 3 in comparison to day 1
 		 1. 5 days
3. Duration of the hospital stay
4. requirement of blood transfusion
5. day 3
6. day 3 
 
Target Sample Size   Total Sample Size="136"
Sample Size from India="136" 
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)   01/11/2022 
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="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Yet Recruiting 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details    
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary   Variceal bleed is the second most common decompensation in cirrhosis after ascites and is associated with an overall mortality of 15-25% at 6 weeks.1 Up to 42% and 72% patients with Child A and Child B/C patients respectively have varices on screening endoscopy.2 Varices develop at the rate of 7-8%/year, and progress from small to large varices at up to 22% at 1 year in patients with Child B/C cirrhosis.3 Elevated portal pressure correlates with the formation of varices, variceal rupture and the severity of the variceal bleed. Hepatic venous portal gradient (HVPG), the most reliable surrogate measure for portal pressure correlates linearly with the development of varices, variceal bleeding and uncontrolled bleeding, developing at an HVPG of 10, 12, and 20mm Hg, respectively.

Albumin, the most abundant serum protein, is synthesized by the hepatocytes and is responsible for 75% of the plasma oncotic pressure.10 Its pleiotropic non-oncotic properties have enabled its use in the management of SBP, acute kidney injury-hepatorenal syndrome, and long-term treatment of decompensated cirrhosis.11 Albumin infusion is associated with a significant reduction in the levels of inflammatory cytokines without changes in the portal hemodynamics.12 In addition to its anti-oxidant and anti-inflammatory effects, albumin acts a potent scavenger of toxic metabolites.13 In principle, albumin infusion should decrease the inflammatory mediators and bacteremia associated with variceal bleed, irrespective of its effects on portal pressures. Previous studies have also shown no effect of albumin infusion on portal pressures, as estimated by the changes in HVPG.12,14 However, the role of albumin in the management of variceal bleed is still unclear. We hypothesize that standard medical therapy (SMT) plus intravenous albumin in patients with cirrhosis and variceal bleeding is associated with a reduction in the composite outcome of secondary bacterial peritonitis (SBP), acute kidney injury (AKI), hepatic encephalopathy (HE) and all-cause mortality at 6 weeks, in comparison to SMT alone.


 
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