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

Institute of Liver and Biliary Sciences, India

Status and phase: Completed; Phase 4

Conditions: Regeneration Liver; Complication, Postoperative

Treatments: Drug: Potassium Phosphate Injection

Study type: Interventional

Funder types: Other

Identifiers

NCT04026438

ILBS-livertransplant

Details and patient eligibility

About

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.

Enrollment: 130 patients

Sex: All

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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130 participants in 2 patient groups

Intervention Arm - potassium phosphate injection

Experimental group

Treatment:

Drug: Potassium Phosphate Injection

Control Arm

No Intervention group