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

January 15, 2024 updated by: Suwasin Udomkarnjananun, King Chulalongkorn Memorial Hospital

Furosemide Stress Test as a Marker of Postoperative Kidney Allograft Function

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

180

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Thailand
      • Bangkok, Thailand, 10330
        • Recruiting
        • King Chulalongkorn Memorial Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Urine output
Time Frame: 6 hours
Urine output per hour (milliliters/hour) after furosemide injection
6 hours

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

King Chulalongkorn Memorial Hospital

Investigators

  • Principal Investigator: suwasin udomkarnjananun, M.D., King Chulalongkorn Memorial Hospital and Chulalongkorn University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 25, 2016

Primary Completion (Estimated)

May 1, 2026

Study Completion (Estimated)

May 1, 2027

Study Registration Dates

First Submitted

February 20, 2017

First Submitted That Met QC Criteria

March 1, 2017

First Posted (Actual)

March 7, 2017

Study Record Updates

Last Update Posted (Actual)

January 17, 2024

Last Update Submitted That Met QC Criteria

January 15, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB 317/59

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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