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

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ClinicalTrials.gov Identifier: NCT03071536
Recruitment Status : Recruiting
First Posted : March 7, 2017
Last Update Posted : October 24, 2017
Sponsor:
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

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
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 : February 2018
Estimated Study Completion Date : May 2018

Resource links provided by the National Library of Medicine

Drug Information available for: Furosemide
U.S. FDA Resources

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



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

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 ClinicalTrials.gov identifier (NCT number): NCT03071536


Contacts
Contact: Suwasin udomkarnjananun, M.D. 66899679885 suwasin.u@gmail.com

Locations
Thailand
King Chulalongkorn Memorial Hospital Recruiting
Bangkok, Thailand, 10330
Contact: Suwasin Udomkarnjananun, M.D.    66899679885    suwasin.u@gmail.com   
Sponsors and Collaborators
King Chulalongkorn Memorial Hospital
Investigators
Principal Investigator: suwasin udomkarnjananun, M.D. King Chulalongkorn Memorial Hospital and Chulalongkorn University

Responsible Party: Suwasin Udomkarnjananun, Suwasin Udomkarnjananun, M.D., King Chulalongkorn Memorial Hospital
ClinicalTrials.gov Identifier: NCT03071536     History of Changes
Other Study ID Numbers: IRB 317/59
First Posted: March 7, 2017    Key Record Dates
Last Update Posted: October 24, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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
perioperation
delayed graft function

Additional relevant MeSH terms:
Delayed Graft Function
Pathologic Processes
Furosemide
Diuretics
Natriuretic Agents
Physiological Effects of Drugs
Sodium Potassium Chloride Symporter Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action