FOSTIK: Furosemide Stress Test Predicting Early Graft Function in Kidney Transplantation

Sponsor

King Chulalongkorn Memorial Hospital (Other)

Overall Status

Recruiting

CT.gov ID

NCT03071536

Collaborator

(none)

180

Enrollment

Location

Arm

77.1

Anticipated Duration (Months)

2.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Furosemide is an old drug that has been used frequently in the postoperative period of kidney transplantation, aiming to achieve adequate urine output. There is no previous study that directly evaluate the urine response to standardized dose of furosemide in the postoperative period. The objective is to measure the urine output after standardized dose of furosemide is delivered, as a biomarker to predict the graft function in perioperative period.

Condition or Disease	Intervention/Treatment	Phase
Kidney Function Kidney Transplant; Complications Delayed Graft Function	Drug: Furosemide Injection	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

180 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

Official Title:

Furosemide Stress Test as a Marker of Postoperative Kidney Allograft Function

Actual Study Start Date :

Nov 25, 2016

Anticipated Primary Completion Date :

May 1, 2022

Anticipated Study Completion Date :

May 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Furosemide Single dose of furosemide 1.5 mg/kg intravenously will be given to all participants at 3 hours post-reperfusion of kidney allograft. Urine output will be recorded hourly for 6 hours.	Drug: Furosemide Injection Furosemide 1.5 mg/kg intravenously at 3 hours post-reperfusion of kidney allograft

Arm

Intervention/Treatment

Experimental: Furosemide

Single dose of furosemide 1.5 mg/kg intravenously will be given to all participants at 3 hours post-reperfusion of kidney allograft. Urine output will be recorded hourly for 6 hours.

Drug: Furosemide Injection

Furosemide 1.5 mg/kg intravenously at 3 hours post-reperfusion of kidney allograft

Outcome Measures

Primary Outcome Measures

Urine output [6 hours]
Urine output per hour (milliliters/hour) after furosemide injection

Secondary Outcome Measures

Delayed graft function [7 days]
Delayed graft function is defined by the necessity of dialysis within the first week after kidney transplantation. (yes/no)
Creatinine reduction ratio [At postoperative day 0,7 and 14]
Ratio of serum creatinine at postoperative day 7 and 14 to day-zero creatinine

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Deceased donor kidney transplantation at KCMH
informed consent is accepted

Exclusion Criteria:

Known allergy to furosemide
Surgical complication of allograft
Urgently needed for dialysis (refractory hypervolemia, uremic symptoms, and hyperkalemia)