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

• Sponsor: Institute of Liver and Biliary Sciences, India (Other)
• Overall Status: Completed
• CT.gov ID: NCT04026438
• Collaborator: (none)
• Enrollment: 130
• Location: 1
• Arms: 2
• Actual Duration (Months): 25.1
• Patients Per Site Per Month: 5.2

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Complication, Postoperative; Regeneration Liver	Drug: Potassium Phosphate Injection	Phase 4

Study Design

• Study Type: Interventional
• Actual Enrollment: 130 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Supportive Care
• Official Title: Randomized Controlled Trial to Study the Outcome of Intravenous Phosphate Supplementation in Live Donors Undergoing Hepatectomy for Living Donor Liver Transplantation (LDLT)
• Actual Study Start Date: Jan 21, 2019
• Actual Primary Completion Date: Feb 24, 2021
• Actual Study Completion Date: Feb 24, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Intervention Arm - potassium phosphate injection	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
No Intervention: Control Arm

Outcome Measures

Primary Outcome Measures

1. Post operative complications [1 month]

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

Secondary Outcome Measures

1. Trend of serum phosphorous levels [1 week]

   Serum phosphorous levels will be done daily and its trend will be compared in both the groups

2. 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

3. 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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 50 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Institute of Liver and Biliary Sciences	New Delhi		India	110070

Sponsors and Collaborators

• Institute of Liver and Biliary Sciences, India

Investigators

• Study Chair: Viniyendra Pamecha, Professor, Professor and Head, Department of HPB surgery and Liver transplantation, ILBS, New Delhi.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Vivek Rajendran, Senior Resident, Department of HPB surgery and liver transplantation, Institute of Liver and Biliary Sciences, India
• ClinicalTrials.gov Identifier: NCT04026438
• Other Study ID Numbers: ILBS-livertransplant
• First Posted: Jul 19, 2019
• Last Update Posted: Nov 2, 2021
• Last Verified: Oct 1, 2021

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Postoperative Complications; Potassium phosphate

Study Results

No Results Posted as of Nov 2, 2021