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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04026438

Enrollment

130

Registered

2019-07-19

Start date

2019-01-21

Completion date

2021-02-24

Last updated

2021-11-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Complication, Postoperative, Regeneration Liver

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.

Interventions

DRUGPotassium 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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

SUPPORTIVE_CARE

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 50 Years

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

Design outcomes

Primary

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

Secondary

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

Countries

India

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026