| 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
|
|
|
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
|
|
|
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. |