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CTRI Number  CTRI/2025/06/088527 [Registered on: 10/06/2025] Trial Registered Prospectively
Last Modified On: 10/06/2025
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Follow Up Study 
Study Design  Single Arm Study 
Public Title of Study   Impact of high belly pressure in adults undergoing liver transplant surgery 
Scientific Title of Study   Incidence of intraabdominal hypertension (IAH) and its impact on postoperative outcomes in adults undergoing living donor liver transplantation (LDLT) 
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 Anil Yadav 
Designation  Assistant Professor 
Affiliation  Institute of Liver and Biliary Sciences 
Address  Department of Anaesthesiology, 3rd floor phase 2, ILBS hospital
Department of anaesthesiology, 3rd floor phase 2, ILBS hospital
New Delhi
DELHI
110070
India 
Phone  8447180304  
Fax    
Email  doc.anilyadav@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Mousumi Saha 
Designation  Senior resident 
Affiliation  Institute of Liver and Biliary Sciences 
Address  Department of Anaesthesiology, 3rd floor phase 2, ILBS hospital, Vasant Kunj
ILBS hospital, Vasant Kunj, New Delhi 110070, India
New Delhi
DELHI
110070
India 
Phone  08447180304  
Fax    
Email  saha.mousumi2006@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Anil Yadav 
Designation  Assistant Professor 
Affiliation  Institute of Liver and Biliary Sciences 
Address  Department of Anaesthesiology, 3rd floor phase 2, ILBS hospital.
Department of anaesthesiology, 3rd floor phase 2, ILBS hospital
New Delhi
DELHI
110070
India 
Phone  8447180304  
Fax    
Email  doc.anilyadav@gmail.com  
 
Source of Monetary or Material Support  
Institute of Liver and Biliary Sciences 
 
Primary Sponsor  
Name  Dr Mousumi Saha 
Address  ILBS hospital, Vasant Kunj, New Delhi 110070, India 
Type of Sponsor  Other [self] 
 
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 Anil Yadav  Institute of Liver and Biliary Sciences  Department of Anaesthesiology, 3rd floor phase 2,ILBS hospital
New Delhi
DELHI 
8447180304

doc.anilyadav@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee (IEC) ILBS  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 
Intervention  NIL  NIL 
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  Adults aged between 18-70 years undergoing LDLT  
 
ExclusionCriteria 
Details  Preoperative renal dysfunction (AKI within 6 weeks, CKD)
Presence of cardiac comorbidity (CAD, severe valvular heart disease, cardiomyopathy, arrhythmias)
Reoperation/retransplant surgery
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Incidence of intraabdominal hypertension (IAH) in adults undergoing LDLT   From day of surgery to till postoperative ICU stay 
 
Secondary Outcome  
Outcome  TimePoints 
The effects of IAH on postoperative outcome after LDLT in terms of -
Incidence of postoperative renal dysfunction
Incidence of postoperative graft dysfunction
Portal vein blood flow
Total duration of mechanical ventilation
Total vasoactive days and cumulative dose
ICU length of stay
ICU outcome (alive / dead)
 
From day of surgery to till postoperative ICU stay 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
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)   21/06/2025 
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="0"
Months="4"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
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  

Monitoring the effects of intra-abdominal hypertension (IAH) has been in practice in a variety of clinical situations, including postsurgical patients and critically ill patients, since its invention in the nineteenth century. The World Society of Abdominal Compartment Syndrome (WSACS) has defined IAH as an intraabdominal pressure (IAP) > 12 mmHg. They also classified IAH into 4 grades: Grade I: IAH of 12–15 mmHg; Grade II: IAH of 16–20 mmHg; Grade III: IAH of 21–25 mmHg; and Grade IV: IAH of >25 mmHg. Abdominal compartment syndrome (ACS) is defined as an IAP > 20 mmHg with evidence of organ failure. Previous studies have documented the adverse physiological effects of IAH on respiratory, hemodynamic, renal, and other visceral functions, thereby affecting postoperative outcome and increasing morbidity and mortality. Patients undergoing living donor liver transplantation (LDLT) are also at risk of IAH due to their preoperative chronic liver disease state, frequent association with tense ascites, the complex nature of the transplant procedure, including the risk of intraperitoneal haemorrhages (surgical bleeding or coagulopathy-related), the use of perihepatic or retroperitoneal packs to control bleeding, bowel congestion due to portal hypertension, massive fluid and blood product administration, Therefore, it is important to monitor IAP in post-LDLT patients. Only 2-3 previous studies were found which showed an association between IAH and a complicated postoperative course after liver transplant in adults irrespective of type of donor. However, to the best of our knowledge, the effects of IAH have not been previously investigated in adult LDLT patients, particularly in Indian population. Through this prospective observational study, we aim to evaluate the incidence of IAH and its impact on postoperative outcome in adult LDLT patients. We will also investigate the possible adverse effects of IAH on renal, respiratory, cardiac, and graft function.

 
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