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

Complication, Postoperative Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04026438
• Other study ID #: ILBS-livertransplant
• Status: Completed
• Phase: Phase 4
• Start date: January 21, 2019
• Est. completion date: February 24, 2021

Study information

• Verified date: October 2021
• Source: Institute of Liver and Biliary Sciences, India
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 130
• Est. completion date: February 24, 2021
• Est. primary completion date: February 24, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Complication, Postoperative
• Postoperative Complications
• Regeneration Liver

Intervention

Drug:
• Potassium Phosphate Injection
One ml of the preparation contains 3 mmol of phosphorous which when equated with RDA 10ml ie 30 mmol of preparation will be supplemented. The preparation is given slowly, intravenously over 4 hours diluted in 500 ml normal saline

Locations

Country	Name	City	State
India	Institute of Liver and Biliary Sciences	New Delhi

Sponsors (1)

Lead Sponsor	Collaborator
Institute of Liver and Biliary Sciences, India

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Post operative complications	Outcome of phosphate supplementation in reducing the occurrence of postoperative complications assessed by Clavien Dindo grading	1 month
Secondary	Trend of serum phosphorous levels	Serum phosphorous levels will be done daily and its trend will be compared in both the groups	1 week
Secondary	Trends in post-operative liver function tests	Liver function tests will be done in both groups and its correlation with serum phosphate levels will be correlated	1 week
Secondary	Duration of hospital, ICU stay	ICU stay and total hospital stay in the group will be assessed	Till patient is discharged on an average of 10 days