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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03071536
Recruitment Status : Recruiting
First Posted : March 7, 2017
Last Update Posted : March 10, 2020
Information provided by (Responsible Party):
Suwasin Udomkarnjananun, King Chulalongkorn Memorial Hospital

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 Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated 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 : November 25, 2016
Estimated Primary Completion Date : May 2022
Estimated Study Completion Date : May 2023

Resource links provided by the National Library of Medicine

Drug Information available for: Furosemide

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

Primary Outcome Measures :
  1. Urine output [ Time Frame: 6 hours ]
    Urine output per hour (milliliters/hour) after furosemide injection

Secondary Outcome Measures :
  1. 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)

  2. 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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03071536

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Contact: Suwasin udomkarnjananun, M.D. 66899679885

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King Chulalongkorn Memorial Hospital Recruiting
Bangkok, Thailand, 10330
Contact: Suwasin Udomkarnjananun, M.D.    66899679885   
Sponsors and Collaborators
King Chulalongkorn Memorial Hospital
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Principal Investigator: suwasin udomkarnjananun, M.D. King Chulalongkorn Memorial Hospital and Chulalongkorn University
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Suwasin Udomkarnjananun, Suwasin Udomkarnjananun, M.D., King Chulalongkorn Memorial Hospital Identifier: NCT03071536    
Other Study ID Numbers: IRB 317/59
First Posted: March 7, 2017    Key Record Dates
Last Update Posted: March 10, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Suwasin Udomkarnjananun, King Chulalongkorn Memorial Hospital:
furosemide stress test
kidney transplantation
urine output
delayed graft function
Additional relevant MeSH terms:
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Delayed Graft Function
Pathologic Processes
Natriuretic Agents
Physiological Effects of Drugs
Sodium Potassium Chloride Symporter Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action