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

NCT04026438 | Completed Phase 4

• 1 other identifier: ILBS-livertransplant
• Study Type: interventional
• Target: 130
• Locations: 1 country
• Sites: 1

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.

Conditions

Complication, Postoperative; Regeneration Liver

Outcome Measures

Primary Outcomes (1)

• Post operative complications

  Outcome of phosphate supplementation in reducing the occurrence of postoperative complications assessed by Clavien Dindo grading

  1 month

Secondary Outcomes (3)

• Trend of serum phosphorous levels

  1 week

• Trends in post-operative liver function tests

  1 week

• Duration of hospital, ICU stay

  Till patient is discharged on an average of 10 days

Study Arms (2)

Intervention Arm - potassium phosphate injection

EXPERIMENTAL

Drug: Potassium Phosphate Injection

Control Arm

NO INTERVENTION

Interventions

Potassium Phosphate Injection DRUG

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

Intervention Arm - potassium phosphate injection

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• Minor hepatectomy
• Those who develop profound hypophosphatemia in the control group

Sponsors & Collaborators

• Institute of Liver and Biliary Sciences, India: lead

Study Sites (1)

Institute of Liver and Biliary Sciences

New Delhi, 110070, India

Location

MeSH Terms

Conditions

Postoperative Complications

Interventions

potassium phosphate

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Viniyendra Pamecha, Professor

  Professor and Head, Department of HPB surgery and Liver transplantation, ILBS, New Delhi.

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Resident, Department of HPB surgery and liver transplantation

Study Record Dates

• First Submitted: July 11, 2019
• First Posted: July 19, 2019
• Study Start: January 21, 2019
• Primary Completion: February 24, 2021
• Study Completion: February 24, 2021
• Last Updated: November 2, 2021

Record last verified: 2021-10

Locations

IN (1)