Delayed Renal Allograft Function and Furosemide Treatment

NCT02312115 | Withdrawn Phase 2 DMC

• 1 other identifier: 5140378
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

This study will be a randomized prospective double-blind placebo-controlled clinical pilot trial. This will be a single center project that will take place at Loma Linda University Medical Center. All adult kidney recipients will be informed of the study prior to operation. The Nephrology fellows or attending physicians will attempt to obtain informed consent from all eligible patients, pre-transplant. Those patients who consent will be screened post operation for enrollment. Patients who do not meet all eligibility criteria and/or who meet some exclusion criteria will be deemed ineligible for the trial, and will be excluded. The Nephrology and Transplant teams will be blinded of patient assignment and only the pharmacy will know the patient's assignment.

Conditions

Delayed Graft Function

Keywords

Renal transplant; Kidney transplant; DGF

Outcome Measures

Primary Outcomes (1)

• The percent of participants receiving a deceased donor kidney that develop Delayed Graft Function (DGF), defined as the need to undergo Renal Replacement Therapy (RRT) within the first seven days after renal transplant.

  7 Days

Secondary Outcomes (7)

• 30-day, 90-day and 12-month creatinine levels and estimated Glomerular Filtration Rate (eGFR)

  30 days, 90 days and 12 months post-transplant

• The need for Renal Replacement Therapy (RRT) 30 days, 90 days and 12 months post-transplant

  30 days, 90 days and 12 months post-transplant

• The time from transplant to Delayed Graft Function (DGF) development

  24 hours

• The incidence of Delayed Graft Function (DGF)

  24 Hours

• The incidence of primary graft non-function

  12 months

Study Arms (2)

Furosemide

ACTIVE COMPARATOR

Patients assigned to the furosemide infusion group will receive furosemide infusions, as outlined in figure 2. This has been adapted from Ostermann et al. (2007) and the SPARK study protocol (Bagshaw et al. 2010). Furosemide will be prepared in bags that contain 1000 mg of furosemide per 250 mL of saline reaching a concentration of 4 mg/mL. All medication and placebo bags will have no identifiers that show what type of drug is being administered, for blinding purposes. Medication and placebo bags will have randomly generated study identifier numbers. The protocol in figure 2 will be followed to achieve a total urine output of 1mL/kg/h. The furosemide infusion rate will not exceed 4mg/min IV as this is the maximum set by the manufacturer.

Drug: Furosemide

Saline

PLACEBO COMPARATOR

All patients assigned to the saline group will receive saline that is equal in volume as compared to the treatment group. The amount of saline given to the patients in the placebo arm is so small that its effect on these patients is negligible. All other aspects of care for the enrolled patient will be managed per primary team and any consultants.

Drug: Placebo

Interventions

Furosemide DRUG

Diuretic

Also known as: Lasix

Furosemide

Placebo DRUG

Saline

Also known as: Saline placebo

Saline

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 years
• Patient with ESRD who has been on RRT (Hemodialysis or Peritoneal dialysis)
• Recipient of deceased donor kidney transplant
• Urine output less than 0.5 mL/kg/h before transplant
• Patient consents to the study
• Patient is not allergic to furosemide or sulfa
• English or Spanish speaking patient
• Patient is oliguric (urine output less than 0.5mL/kg/h, as per AKIN criteria) or anuric (urine output less than 10 mL in 6 hours post-transplant or 2 mL/h) in the first 6 hours post kidney transplant

You may not qualify if:

• Recipients of a living donor kidney transplant
• Patients who do not consent for the study
• Patients age \<18 years
• Patients who are allergic to furosemide or sulfa containing medications
• Non-oliguric patients
• Patients who require immediate dialysis within 6 hours of the transplant (before enrollment)
• Patients with renal ischemia due to vascular compromise that has been confirmed with Doppler Ultrasound right after transplant as per standard of care
• Patients who return to the operating room due to complications within 24 hours
• Simultaneous multi-organ transplant recipients
• Hypotensive patients with BP \<90/60 or MAP \<60 mmHg
• Patients who are on vasopressors at any time during study period
• Non-English or Spanish speaking patient

Sponsors & Collaborators

• Loma Linda University: lead

Study Sites (1)

Loma Linda University Medical Center

Loma Linda, California, 92354, United States

Location

MeSH Terms

Conditions

Delayed Graft Function

Interventions

Furosemide

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Sulfanilamides; Sulfonamides; Amides; Organic Chemicals; Aniline Compounds; Amines; Sulfones; Sulfur Compounds

Study Officials

• Amir Abdipour, MD

  Attending Nephrologist, Loma Linda University Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 25, 2014
• First Posted: December 9, 2014
• Study Start: September 1, 2016
• Primary Completion: October 1, 2016
• Study Completion: October 1, 2016
• Last Updated: November 25, 2016

Record last verified: 2016-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)