Furosemide Stress Test Predicting Early Graft Function in Kidney Transplantation

Kidney Transplant; Complications Clinical Trial

— FOSTIK  

Official title:

Furosemide Stress Test as a Marker of Postoperative Kidney Allograft Function

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03071536
• Other study ID #: IRB 317/59
• Status: Recruiting
• Phase: N/A
• Start date: November 25, 2016
• Est. completion date: May 2027

Study information

• Verified date: January 2024
• Source: King Chulalongkorn Memorial Hospital
• Contact: Suwasin udomkarnjananun, M.D.
• Phone: 66899679885
• Email: suwasin.u[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 180
• Est. completion date: May 2027
• Est. primary completion date: May 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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)

Related Conditions & MeSH terms

• Delayed Graft Function
• Kidney Function
• Kidney Transplant; Complications

Intervention

Drug:
• Furosemide Injection
Furosemide 1.5 mg/kg intravenously at 3 hours post-reperfusion of kidney allograft

Locations

Country	Name	City	State
Thailand	King Chulalongkorn Memorial Hospital	Bangkok

Sponsors (1)

Lead Sponsor	Collaborator
King Chulalongkorn Memorial Hospital

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Urine output	Urine output per hour (milliliters/hour) after furosemide injection	6 hours
Secondary	Delayed graft function	Delayed graft function is defined by the necessity of dialysis within the first week after kidney transplantation. (yes/no)	7 days
Secondary	Creatinine reduction ratio	Ratio of serum creatinine at postoperative day 7 and 14 to day-zero creatinine	At postoperative day 0,7 and 14