Randomized Controlled Trial to Study the Outcome of Intravenous Phosphate Supplementation in Live Donors Undergoing Hepatectomy for Living Donor Liver Transplantation (LDLT)

Phase 4

Completed

• Conditions: Regeneration Liver; Complication, Postoperative
• Interventions: Drug: Potassium Phosphate Injection

• Registration Number: NCT04026438
• Lead Sponsor: Institute of Liver and Biliary Sciences, India

Brief Summary

In this study, we aim to analyse the effect of phosphate supplementation on donors undergoing partial hepatectomy for LDLT. In Group A, we are going to supplement phosphate in donors postoperatively from day 1 to day 5. We will analyse the trend of serum phosphate levels in donors postoperatively, its correlation with occurrence of postoperative complications and status of liver regeneration by CT volumetry on Day 7. Group B will constitute the controls for the study and hence attempt to find out the effect of phosphate supplementation in all donors postoperatively. We will analyse the data and elucidate the value of phosphate supplementation in reducing the occurrence of complications and effect on liver regeneration in donors in LDLT.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-01-21
• Study First Submitted: 2019-07-11
• Study First Submitted QC: 2019-07-17
• Study First Posted: 2019-07-19
• Primary Completion: 2021-02-24
• Study Completion: 2021-02-24
• Status Verified: 2021-10
• Last Update Submitted: 2021-10-26
• Last Update Posted: 2021-11-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 130

Inclusion Criteria

• All donors evaluated as per institutional protocol for donor hepatectomy and found fit
• Those who consent.

Exclusion Criteria

• Patients refusing to consent for inclusion in the study.
• Minor hepatectomy
• Those who develop profound hypophosphatemia in the control group

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention Arm - potassium phosphate injection	Potassium Phosphate Injection	-

Primary Outcome Measures

Name	Time	Method
Post operative complications	1 month	Outcome of phosphate supplementation in reducing the occurrence of postoperative complications assessed by Clavien Dindo grading

Secondary Outcome Measures

Name	Time	Method
Trend of serum phosphorous levels	1 week	Serum phosphorous levels will be done daily and its trend will be compared in both the groups
Duration of hospital, ICU stay	Till patient is discharged on an average of 10 days	ICU stay and total hospital stay in the group will be assessed
Trends in post-operative liver function tests	1 week	Liver function tests will be done in both groups and its correlation with serum phosphate levels will be correlated

Trial Locations

Locations (1)

Institute of Liver and Biliary Sciences; 🇮🇳 New Delhi, India