NCT03071536

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
180

participants targeted

Target at P75+ for not_applicable

Timeline
12mo left

Started Nov 2016

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress91%
Nov 2016May 2027

Study Start

First participant enrolled

November 25, 2016

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

February 20, 2017

Completed
15 days until next milestone

First Posted

Study publicly available on registry

March 7, 2017

Completed
9.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2026

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2027

Expected
Last Updated

January 17, 2024

Status Verified

January 1, 2024

Enrollment Period

9.4 years

First QC Date

February 20, 2017

Last Update Submit

January 15, 2024

Conditions

Keywords

furosemide stress testkidney transplantationurine outputperioperationdelayed graft function

Outcome Measures

Primary Outcomes (1)

  • Urine output

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

    6 hours

Secondary Outcomes (2)

  • Delayed graft function

    7 days

  • Creatinine reduction ratio

    At postoperative day 0,7 and 14

Study Arms (1)

Furosemide

EXPERIMENTAL

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

Interventions

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

Furosemide

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Deceased donor kidney transplantation at KCMH
  • informed consent is accepted

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

King Chulalongkorn Memorial Hospital

Bangkok, 10330, Thailand

RECRUITING

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Delayed Graft Function

Interventions

Furosemide

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

SulfanilamidesSulfonamidesAmidesOrganic ChemicalsAniline CompoundsAminesSulfonesSulfur Compounds

Study Officials

  • suwasin udomkarnjananun, M.D.

    King Chulalongkorn Memorial Hospital and Chulalongkorn University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Suwasin udomkarnjananun, M.D.

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Suwasin Udomkarnjananun, M.D.

Study Record Dates

First Submitted

February 20, 2017

First Posted

March 7, 2017

Study Start

November 25, 2016

Primary Completion

May 1, 2026

Study Completion (Estimated)

May 1, 2027

Last Updated

January 17, 2024

Record last verified: 2024-01

Locations