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NCT Number: NCT04026438

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

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.

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Key information

Conditions

Complication, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Regeneration Liver

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Institute of Liver and Biliary Sciences

New Delhi, 110070, India

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Primary outcomes

  1. Post operative complications

    Time frame: 1 month

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

Secondary outcomes

  1. Trend of serum phosphorous levels

    Time frame: 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

    Time frame: 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

    Time frame: Till patient is discharged on an average of 10 days

    ICU stay and total hospital stay in the group will be assessed

Sponsors and collaborators

Lead sponsor

Institute of Liver and Biliary Sciences, India

Other

Registry information

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Jul 19, 2019
Registry last updated
Nov 2, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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