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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)

NCT ID: NCT04026438

Last Updated: 2021-11-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

130 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-01-21

Study Completion Date

2021-02-24

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.

Detailed Description

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Conditions

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Complication, Postoperative Regeneration Liver

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Intervention Arm - potassium phosphate injection

Group Type EXPERIMENTAL

Potassium Phosphate Injection

Intervention Type 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

Control Arm

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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

Intervention Type DRUG

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Institute of Liver and Biliary Sciences, India

OTHER

Sponsor Role lead

Responsible Party

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Vivek Rajendran

Senior Resident, Department of HPB surgery and liver transplantation

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Viniyendra Pamecha, Professor

Role: STUDY_CHAIR

Professor and Head, Department of HPB surgery and Liver transplantation, ILBS, New Delhi.

Locations

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Institute of Liver and Biliary Sciences

New Delhi, , India

Site Status

Countries

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India

Other Identifiers

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ILBS-livertransplant

Identifier Type: -

Identifier Source: org_study_id