Role of Perioperative Pentoxifylline on Liver Regeneration in Living Donor Liver Transplantation
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 75
- Locations
- 1
- Primary Endpoint
- the liver regeneration at POD 8 which will measured by non-contrast three-dimensional computed tomography/magnetic resonance imaging
Study Overview
Brief Summary
After written informed consent, a pilot study will be conducted with 10 patients to assess for feasibility and drug safety following which the double-blinded randomized control trial (DB- RCT) will be carried out. For the DB- RCT, the patients will be randomized using computer generated randomization charts in to two groups: the Pentox group (Group I) and the Placebo group (Group C). The randomization and drug delivery will be done by independent personnel (Third party - not related to the study). The patients in the Pentox arm will receive Oral pentoxifylline 24 hours before LDLT at doses upto 15mg/kg in three divided doses and then continued till 7 days postoperatively. The control group will receive color-matched multivitamin tablets as placebo. Monitoring for drug related adverse events described according to the product monograph will be closely carried out. These include: cardiovascular system: Arrhythmias, unexplained tachycardia; Central nervous system: Dizziness, headache, somnolence; Gastrointestinal symptoms: Nausea, vomiting, heartburn, constipation.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Masking
- Participant, Investigator and Outcome Assessor Blinded
Eligibility Criteria
- Ages
- 18.00 Year(s) to 80.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •all Living donor liver transplant recipients with an expected graft recipient weight ratio less than 0.8.
Exclusion Criteria
- •Unwilling for participation, acute liver failure and acute on chronic liver failure, MELD score more than 30, chronic kidney disease, cardiac dysfunction such as arrhythmia, heart blocks and coronary artery disease.
Outcomes
Primary Outcomes
the liver regeneration at POD 8 which will measured by non-contrast three-dimensional computed tomography/magnetic resonance imaging
Time Frame: till 8 th postoperative day
Secondary Outcomes
- 1. Assessment of the incidence of small for size syndrome(2. Assessment of degree of postoperative liver injury by daily measurement of postoperative serum transaminases, bilirubin and prothrombin time (PT)/international normalized ratio (INR) until POD 7)
Investigators
Susan Paulin
Dr Rela Institute And Medical Centre