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Trial record 29 of 242 for:    furosemide

Delayed Renal Allograft Function and Furosemide Treatment (DRAFFT)

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ClinicalTrials.gov Identifier: NCT02312115
Recruitment Status : Withdrawn (Lack of funding)
First Posted : December 9, 2014
Last Update Posted : November 25, 2016
Sponsor:
Information provided by (Responsible Party):
Loma Linda University

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.

Condition or disease Intervention/treatment Phase
Delayed Graft Function Drug: Furosemide Drug: Placebo Phase 2

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: DRAFFT Trial: Delayed Renal Allograft Function and Furosemide Treatment: A Randomized Prospective Double-blinded Placebo-controlled Clinical Pilot Trial
Study Start Date : September 2016
Actual Primary Completion Date : October 2016
Actual Study Completion Date : October 2016

Resource links provided by the National Library of Medicine

Drug Information available for: Furosemide

Arm Intervention/treatment
Active Comparator: Furosemide
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
Diuretic
Other Name: Lasix

Placebo Comparator: Saline
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
Saline
Other Name: Saline placebo




Primary Outcome Measures :
  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. [ Time Frame: 7 Days ]

Secondary Outcome Measures :
  1. 30-day, 90-day and 12-month creatinine levels and estimated Glomerular Filtration Rate (eGFR) [ Time Frame: 30 days, 90 days and 12 months post-transplant ]
  2. The need for Renal Replacement Therapy (RRT) 30 days, 90 days and 12 months post-transplant [ Time Frame: 30 days, 90 days and 12 months post-transplant ]
  3. The time from transplant to Delayed Graft Function (DGF) development [ Time Frame: 24 hours ]
  4. The incidence of Delayed Graft Function (DGF) [ Time Frame: 24 Hours ]
  5. The incidence of primary graft non-function [ Time Frame: 12 months ]
  6. Overall hospital length of stay [ Time Frame: 30 days ]
  7. The Kidney Profile Donor Index (KDPI) score in relation to primary graft non-function [ Time Frame: 12 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

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): NCT02312115


Locations
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United States, California
Loma Linda University Medical Center
Loma Linda, California, United States, 92354
Sponsors and Collaborators
Loma Linda University
Investigators
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Principal Investigator: Amir Abdipour, MD Attending Nephrologist, Loma Linda University Medical Center

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Responsible Party: Loma Linda University
ClinicalTrials.gov Identifier: NCT02312115     History of Changes
Other Study ID Numbers: 5140378
First Posted: December 9, 2014    Key Record Dates
Last Update Posted: November 25, 2016
Last Verified: November 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Loma Linda University:
Renal transplant
Kidney transplant
DGF
Additional relevant MeSH terms:
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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