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Trial record 10 of 41 for:    Recruiting, Not yet recruiting, Available Studies | "Living Donors"

Remote Ischemic Preconditioning Living Donor Renal Transplant Protocol

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ClinicalTrials.gov Identifier: NCT03084666
Recruitment Status : Recruiting
First Posted : March 21, 2017
Last Update Posted : April 30, 2018
Sponsor:
Information provided by (Responsible Party):
Mali Mathru, University of Alabama at Birmingham

Brief Summary:
In this study, patients undergoing live donor kidney transplantation will be allocated to the control group or remote ischemic preconditioning group (RIPC). RIPC is the utilization of short periods of ischemia to provide protection of the myocardium or other organ (i.e. kidney) from a subsequent ischemic event. Before allograft implantation, RIPC will be accomplished in the recipient and donor by inducing intermittent extremity ischemia through intermittent inflation of an extremity tourniquet three times for five-minute intervals with five minutes of deflation between inflation periods. The monitored clinical end points will include total urine output following kidney reperfusion over five days, plasma creatinine declination over five days, initiation of dialysis, and development of graft injury. Magnitude of graft injury is the primary endpoint and will be measured using biochemical markers, such as, plasma and urinary concentration of neutrophil gelatinase associated lipocalin (NGAL), IL-18, and KIM-1. The sample size calculation is based on a projected difference of NGAL levels between the two study arms. Hall et al reported a mean NGAL level of 49 mg/mL (SD = 37 mg/mL) for a group of patients that had immediate graph function and a mean NGAL level of 248 mg/mL in a group of patients with slow graft function. (which Hall reference is this) Based on these data, a conservative estimate of a mean difference between study groups will be considered 35 mg/mL NGAL. Using these assumptions, an alpha level of 0.05 and 80% power, a sample size of n= 19 per study group will be calculated. By rejecting our null hypothesis, RIPC may serve as a safe, cost-effective protective strategy to prevent allograft injury in the clinical setting of live donor kidney transplantation.

Condition or disease Intervention/treatment Phase
Renal Disease Device: Zimmer ATS tourniquet system Not Applicable

Detailed Description:
All female patients of childbearing age that qualify for this study will receive a urinary pregnancy test prior to enrollment. Application of a tourniquet will occur after induction of anesthesia and intubation with minimal possibility of causing discomfort as the patient will be anesthetized. The tourniquet will be applied preferably to a leg but an arm will be used if a leg is unavailable. The tourniquet will be inflated for three 5 minute intervals over a 30 minute period of time using the Zimmer A.T.S. 2000 Tourniquet System. Patients will be randomly allocated to one of two groups. The experimental group will have the tourniquet inflated on the leg or arm to 200 mmHg. The control group will have the tourniquet inflated on the leg or arm to only 20 mmHg. An audible timer will be used to help alert investigators that the tourniquet is in need of deflation after each 5-minute interval. The tourniquet will be removed after the needed 30 minutes of inflation/deflation to prevent inadvertent inflation of the tourniquet. Blood and Urine specimens will be labeled with patient name and medical record number. Urine samples will be taken in the operating room and at 6,12,24,48 hours postoperatively to test for urinary biomarkers at the O'Brien Clinical Research Center. Blood samples for calculation of serum blood urea nitrogen and creatinine will be collected/processed/distributed/stored according to current UAB main laboratory guidelines as this test is routinely ordered on renal transplant patients. Urinary biomarker laboratory testing samples will be obtained by a bedside nurse placed in a routine urine sample container and a co-investigator will then bring samples to the laboratory where the samples will be tested for NGAL, KIM-1, and IL-18. Blood samples will be taken daily for the first 5 days. A blood sample will be taken from the patient at 1 month to determine the serum blood urea nitrogen level and the creatinine level. The degree of allograft injury will be assessed by the levels of urinary biomarkers NGAL, IL-18, and KIM-1. Incidence of allograft or transplanted kidney primary malfunction will be based on urine output during the first three days after transplantation, the one month serum creatinine concentration, one month estimated glomerular filtration rate calculated according to diet modification. Additional secondary endpoints include 90-day mortality, length of ICU stay, and length of hospital stay. There is a low probability of tourniquet postoperative pain secondary to time of tourniquet inflation being both intermittent and for a short period of time. Inconvenience includes phone discussions with researchers/coordinators and preoperative discussions addressing risks and benefits of the study. Tourniquets will not be placed on extremities with preexisting arteriovenous fistulas or grafts utilized for hemodialysis. In addition, tourniquets will be placed after oscillometric blood pressure cuff placement for intraoperative anesthesia/surgical monitoring to provide adequate patient blood pressure assessment. The tourniquet will not be placed on the same extremity as the oscillometric blood pressure cuff. The primary investigator or a co-investigator will be present during times of tourniquet inflation. The patient will be assessed for complications immediately after tourniquet removal, in the PACU, and in the ICU/or step down unit. Finally, patient complication assessment will occur on the transplant floor after effects of anesthesia have completely resolved within 24 hours of tourniquet application. The extremity will also be assessed for injury at the 1-month follow up visit.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: In this study, patients undergoing live donor kidney transplantation will be allocated to the control group or remote ischemic preconditioning group (RIPC). RIPC is the utilization of short periods of ischemia to provide protection of the myocardium or other organ (i.e. kidney) from a subsequent ischemic event.
Masking: Single (Participant)
Primary Purpose: Prevention
Official Title: Remote Ischemic Preconditioning Living Donor Renal Transplant Protocol
Actual Study Start Date : July 2, 2014
Estimated Primary Completion Date : June 13, 2018
Estimated Study Completion Date : June 30, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Treatment Group
The treatment will receive 200 mmHg of pressure from a Zimmer ATS tourniquet system for three 5 minute intervals.
Device: Zimmer ATS tourniquet system
The tourniquet is the same kind that is used in orthopedic surgeries to limit blood loss in arm or leg surgery. It can be inflated to a set pressure for a set amount of time.

Experimental: Control Group
Our control group will receive 20 mmHg of pressure from a Zimmer ATS tourniquet system for three 5 minute intervals.
Device: Zimmer ATS tourniquet system
The tourniquet is the same kind that is used in orthopedic surgeries to limit blood loss in arm or leg surgery. It can be inflated to a set pressure for a set amount of time.




Primary Outcome Measures :
  1. Remote Ischemic Preconditioning (RIPC) [ Time Frame: 30 minutes ]
    RIPC may serve as a safe, cost-effective protective strategy to prevent allograft injury in the clinical setting of live donor kidney transplantation.



Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • > OR = 19 years of age receiving a living donor renal transplant and their donors

Exclusion Criteria:

  • < 19 years of age
  • No safe extremity to place tourniquet
  • Patients with previous muscle, vascular, or nerve injury to an extremity,
  • Patients with only one available extremity that has an arteriovenous fistula
  • Patients who are hemodialysis dependent who have not received hemodialysis in the past 4 days
  • Paraplegic/quadriplegic patients
  • Active pathologic cutaneous lesions on extremities
  • Patients with a history of tourniquet pain or CRPS
  • Pregnant patients

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): NCT03084666


Contacts
Contact: Betty Herard, MBA, MA 205-934-0045 bherard@uabmc.edu
Contact: Ayesha Bryant, MSPH, MD 205-996-7383

Locations
United States, Alabama
UAB Department of Anesthesiology and Perioperative Medicine Recruiting
Birmingham, Alabama, United States, 35249
Contact: Betty Herard, MBA, MA    205-934-0045    bherard@uabmc.edu   
Contact: Ayesha Bryant, MSPH, MD    205-996-7383    asbryant@uabmc.edu   
Principal Investigator: Mali Mathru, MD         
Sponsors and Collaborators
University of Alabama at Birmingham
Investigators
Principal Investigator: Mali Mathru, MD UAB Department of Anesthesiology and Perioperative Medicine

Responsible Party: Mali Mathru, Principal Investigator, University of Alabama at Birmingham
ClinicalTrials.gov Identifier: NCT03084666     History of Changes
Other Study ID Numbers: F130312023
First Posted: March 21, 2017    Key Record Dates
Last Update Posted: April 30, 2018
Last Verified: April 2018
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: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: Yes