Back to resultsRandomized Controlled Trial to Study the Outcome of Intravenous Phosphate Supplementation in Live Donors Undergoing Hepatectomy for Living Donor Liver Transplantation (LDLT)
Primary Purpose
Complication, Postoperative, Regeneration Liver
Status
Completed
Phase
Phase 4
Locations
India
Study Type
Interventional
Intervention
Potassium Phosphate Injection
Sponsored by
About this trial
This is an interventional supportive care trial for Complication, Postoperative
Eligibility Criteria
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
Sites / Locations
- Institute of Liver and Biliary Sciences
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Intervention Arm - potassium phosphate injection
Control Arm
Arm Description
Outcomes
Primary Outcome Measures
Post operative complications
Outcome of phosphate supplementation in reducing the occurrence of postoperative complications assessed by Clavien Dindo grading
Secondary Outcome Measures
Trend of serum phosphorous levels
Serum phosphorous levels will be done daily and its trend will be compared in both the groups
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
Duration of hospital, ICU stay
ICU stay and total hospital stay in the group will be assessed
Full Information
NCT ID
NCT04026438
First Posted
July 11, 2019
Last Updated
October 26, 2021
Sponsor
Institute of Liver and Biliary Sciences, India
1. Study Identification
Unique Protocol Identification Number
NCT04026438
Brief Title
Randomized Controlled Trial to Study the Outcome of Intravenous Phosphate Supplementation in Live Donors Undergoing Hepatectomy for Living Donor Liver Transplantation (LDLT)
Official Title
Randomized Controlled Trial to Study the Outcome of Intravenous Phosphate Supplementation in Live Donors Undergoing Hepatectomy for Living Donor Liver Transplantation (LDLT)
Study Type
Interventional
2. Study Status
Record Verification Date
October 2021
Overall Recruitment Status
Completed
Study Start Date
January 21, 2019 (Actual)
Primary Completion Date
February 24, 2021 (Actual)
Study Completion Date
February 24, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Institute of Liver and Biliary Sciences, India
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Complication, Postoperative, Regeneration Liver
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
130 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intervention Arm - potassium phosphate injection
Arm Type
Experimental
Arm Title
Control Arm
Arm Type
No Intervention
Intervention Type
Drug
Intervention Name(s)
Potassium Phosphate Injection
Intervention Description
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 Outcome Measure Information:
Title
Post operative complications
Description
Outcome of phosphate supplementation in reducing the occurrence of postoperative complications assessed by Clavien Dindo grading
Time Frame
1 month
Secondary Outcome Measure Information:
Title
Trend of serum phosphorous levels
Description
Serum phosphorous levels will be done daily and its trend will be compared in both the groups
Time Frame
1 week
Title
Trends in post-operative liver function tests
Description
Liver function tests will be done in both groups and its correlation with serum phosphate levels will be correlated
Time Frame
1 week
Title
Duration of hospital, ICU stay
Description
ICU stay and total hospital stay in the group will be assessed
Time Frame
Till patient is discharged on an average of 10 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Viniyendra Pamecha, Professor
Organizational Affiliation
Professor and Head, Department of HPB surgery and Liver transplantation, ILBS, New Delhi.
Official's Role
Study Chair
Facility Information:
Facility Name
Institute of Liver and Biliary Sciences
City
New Delhi
ZIP/Postal Code
110070
Country
India
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Randomized Controlled Trial to Study the Outcome of Intravenous Phosphate Supplementation in Live Donors Undergoing Hepatectomy for Living Donor Liver Transplantation (LDLT)
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