search
Back to results

Furosemide Stress Test Predicting Early Graft Function in Kidney Transplantation (FOSTIK)

Primary Purpose

Kidney Function, Kidney Transplant; Complications, Delayed Graft Function

Status
Recruiting
Phase
Not Applicable
Locations
Thailand
Study Type
Interventional
Intervention
Furosemide Injection
Sponsored by
King Chulalongkorn Memorial Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Kidney Function focused on measuring furosemide stress test, kidney transplantation, urine output, perioperation, delayed graft function

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept 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)

Sites / Locations

  • King Chulalongkorn Memorial HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Furosemide

Arm Description

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.

Outcomes

Primary Outcome Measures

Urine output
Urine output per hour (milliliters/hour) after furosemide injection

Secondary Outcome Measures

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

Full Information

First Posted
February 20, 2017
Last Updated
November 10, 2022
Sponsor
King Chulalongkorn Memorial Hospital
search

1. Study Identification

Unique Protocol Identification Number
NCT03071536
Brief Title
Furosemide Stress Test Predicting Early Graft Function in Kidney Transplantation
Acronym
FOSTIK
Official Title
Furosemide Stress Test as a Marker of Postoperative Kidney Allograft Function
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Recruiting
Study Start Date
November 25, 2016 (Actual)
Primary Completion Date
May 2024 (Anticipated)
Study Completion Date
May 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
King Chulalongkorn Memorial Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Kidney Function, Kidney Transplant; Complications, Delayed Graft Function
Keywords
furosemide stress test, kidney transplantation, urine output, perioperation, delayed graft function

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
180 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Furosemide
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Furosemide Injection
Intervention Description
Furosemide 1.5 mg/kg intravenously at 3 hours post-reperfusion of kidney allograft
Primary Outcome Measure Information:
Title
Urine output
Description
Urine output per hour (milliliters/hour) after furosemide injection
Time Frame
6 hours
Secondary Outcome Measure Information:
Title
Delayed graft function
Description
Delayed graft function is defined by the necessity of dialysis within the first week after kidney transplantation. (yes/no)
Time Frame
7 days
Title
Creatinine reduction ratio
Description
Ratio of serum creatinine at postoperative day 7 and 14 to day-zero creatinine
Time Frame
At postoperative day 0,7 and 14

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Suwasin udomkarnjananun, M.D.
Phone
66899679885
Email
suwasin.u@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
suwasin udomkarnjananun, M.D.
Organizational Affiliation
King Chulalongkorn Memorial Hospital and Chulalongkorn University
Official's Role
Principal Investigator
Facility Information:
Facility Name
King Chulalongkorn Memorial Hospital
City
Bangkok
ZIP/Postal Code
10330
Country
Thailand
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Suwasin Udomkarnjananun, M.D.
Phone
66899679885
Email
suwasin.u@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
30636249
Citation
Udomkarnjananun S, Townamchai N, Iampenkhae K, Petchlorlian A, Srisawat N, Katavetin P, Sutherasan M, Santingamkun A, Praditpornsilpa K, Eiam-Ong S, Avihingsanon Y. Furosemide Stress Test as a Predicting Biomarker for Delayed Graft Function in Kidney Transplantation. Nephron. 2019;141(4):236-248. doi: 10.1159/000495765. Epub 2019 Jan 11.
Results Reference
derived

Learn more about this trial

Furosemide Stress Test Predicting Early Graft Function in Kidney Transplantation

We'll reach out to this number within 24 hrs