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

Study Overview
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Brief Summary
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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.

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

Conditions
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Complication, Postoperative, Regeneration Liver

Intervention / Treatment
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* Drug: Potassium Phosphate Injection


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention Arm - potassium phosphate injection<br> | Drug: Potassium Phosphate Injection<br>* 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<br>|
| No Intervention: Control Arm<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Post operative complications | Outcome of phosphate supplementation in reducing the occurrence of postoperative complications assessed by Clavien Dindo grading | 1 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Trend of serum phosphorous levels | Serum phosphorous levels will be done daily and its trend will be compared in both the groups | 1 week | 
| 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 | 
| 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 |