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Remote Ischemic Preconditioning in Neurological Death Organ Donors (RIPNOD)

This study has been completed.
Sponsor:
Collaborators:
Health Resources and Services Administration (HRSA)
The University of Texas Health Science Center at San Antonio
Information provided by (Responsible Party):
Rutgers, The State University of New Jersey
ClinicalTrials.gov Identifier:
NCT01515072
First received: October 28, 2011
Last updated: April 6, 2017
Last verified: April 2016
  Purpose

The purpose of this study is to determine whether application of lower limb remote ischemic preconditioning (RIPC) after determination of brain death improves donor stability, organ quality, organ yield, and early post transplant clinical outcomes.

Neurological death donors will be stratified into standard and extended criteria donors (SCD/ECD) and randomized in a 1:1 fashion to RIPC or No intervention. The primary outcome is the number of organs recovered per donor. Secondary outcomes include donor hemodynamic state, donor organ-specific function parameters, pulsatile perfusion parameters, number of organs transplanted per donor, recipient hospital free survival and delayed graft function of kidneys. The sample size is powered to detect a difference of 0.44 organs recovered.


Condition Intervention
Organ Transplantation Other: RIPC (Remote Ischemic Preconditioning)

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Remote Ischemic Preconditioning in Neurological Death Organ Donors

Further study details as provided by Rutgers, The State University of New Jersey:

Primary Outcome Measures:
  • Number of Organs Recovered Per Donor [ Time Frame: At time of organ recovery, up to 1 day ]
    Number of organs recovered per organ donor


Secondary Outcome Measures:
  • Number of Organs Transplanted Per Donor [ Time Frame: Within 24 hours of organ recovery ]
    Number of organs transplanted from each organ donor

  • Change in Vasopressor Score [ Time Frame: Vasopressor score was determined before aortic cross clamp minus the value prior to the first intervention, an average of 19 hours ]

    Changes in the following: Vasopressor usage, serum Lactate, Creatinine clearance, arterial oxygen pressure:fraction of inspired oxygen (P:F) ratios, Lung Compliance, Cardiac biomarkers, ejection fraction (EF) from 2-dimensional Echocardiogram.

    Here we will present data for the change in vasopressor use evaluated using a vasopressor score.

    A numerical score calculated for number and dose of Vasopressors in use. The score is calculated using the following formula (from Zuppa AF et. al.CRIT CARE MED 2004 Vol. 32 p 2318-2322):

    Vasopressor Score= (dopamine dose[y=ug/kg/min x 1]) + (dobutamine dose [ug/kg/min] x 1) + (epinephrine dose [ug/kg/min] x100) + (norepinephrine dose [ug/kg/min] x 100) + (phenylephrine dose [ug/kg/min] x 100).

    The range for our study was 0-4900 with higher doses indicating higher vasopressor use in the donor.


  • Change in Serum Lactate [ Time Frame: Subjects will be followed from admission to explantation, an average of 4.5 days ]
    Change in serum lactate levels (mg/dL) from before intervention to the final value

  • Change in Creatinine Clearance [ Time Frame: Subjects will be followed from admission to explantation, an average of 4.5 days ]
    Change in creatinine clearance (mL/min by Cockcroft-Gault method) from before intervention to terminal value

  • Change in P:F Ratio [ Time Frame: Subjects will be followed from admission to explantation, an average of 4.5 days ]
    Change in ratio of arterial oxygen pressure:fraction inspired oxygen ratio from before intervention to terminal value

  • Change in Dynamic Compliance [ Time Frame: Subjects will be followed from admission to explantation, an average of 4.5 days ]

    Change in dynamic compliance of the lung from before intervention to terminal value

    Cdyn = Dynamic compliance; Vt = tidal volume; PIP = Peak inspiratory pressure (the maximum pressure during inspiration); PEEP = Positive End Expiratory Pressure:

    Cdyn= Vt/PIP - PEEP


  • Change in Troponins [ Time Frame: Subjects will be followed from admission to explantation, an average of 4.5 days ]
    Change in serum troponin I (ng/mL) from before intervention to terminal value

  • Pulsatile Perfusion Flow [ Time Frame: Up to 24 hours of machine perfusion ]
    Perfusate flow (mL/min) in machine perfused kidneys.

  • Six Month Hospital Free Survival of All Organ Recipients [ Time Frame: 6 months post-transplant ]
    Six month hospital-free survival was defined as the number of days recipients survived following the initial discharge after the transplant.

  • Delayed Graft Function (DGF) of Kidney Recipients. [ Time Frame: 7 days post-transplant ]
    DGF is defined as the need for dialysis within the first week post transplantation.

  • Pulsatile Perfusion Parameters [ Time Frame: Up to 24 hours of machine perfusion ]
    Perfusate resistance (mm Hg/mL/min) in machine perfused kidneys.


Enrollment: 321
Study Start Date: July 2011
Study Completion Date: April 2015
Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: No Remote Ischemic Preconditioning
The donors assigned to this group will receive standard of care of management of brain death donors in each organ procurement organization.
Experimental: Remote Ischemic Preconditioning
The donors assigned to this group would receive two RIPC interventions. The first one would occur immediately after brain death declaration and consent for organ donation. The second one would occur immediately before commencement of organ recovery. At each occasion RIPC would be induced by 4 cycles of mid-thigh inflation of tourniquet for 5 min followed by deflation for 5 minutes.
Other: RIPC (Remote Ischemic Preconditioning)
Remote Ischemic Preconditioning (RIPC) by Inflation of Pneumatic Tourniquet. The intervention will consist of tourniquet inflation on the mid-thigh for 5 minutes, followed by a deflation period of 5 minutes for a total of 4 cycles. The intervention will take place at two time points: First, after determination of brain death and consent for organ donation and again upon incision for organ recovery. The second intervention will occur in a manner identical to the first intervention but in the opposite limb.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   6 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Neurological death donors in whom brain death determination is imminent
  2. First person consent or next of kin consent for research
  3. Donors >=6 years of age
  4. Organ recovery not expected within 6 hours of consent.
  5. Both sexes and ethnicities.

Exclusion Criteria:

  1. Donation after cardiac death donors (DCD)
  2. Live organ donors
  3. No first person consent and next of kin decline research consent
  4. Donor Age < 6 years
  5. Lower extremity trauma or recent amputation
  6. Tissue only donors
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01515072

Locations
United States, New Jersey
Rutgers, The State University of New Jersey
Newark, New Jersey, United States, 07101
United States, Texas
University of Texas Health Science Center at San Antonio
San Antonio, Texas, United States, 78229
Sponsors and Collaborators
Rutgers, The State University of New Jersey
Health Resources and Services Administration (HRSA)
The University of Texas Health Science Center at San Antonio
Investigators
Principal Investigator: Baburao Koneru, MD University of Medicine and Dentistry New Jersey-Newark
Principal Investigator: William K Washburn, MD University of Texas Health Sciences at San Antonio
  More Information

Responsible Party: Rutgers, The State University of New Jersey
ClinicalTrials.gov Identifier: NCT01515072     History of Changes
Other Study ID Numbers: 0120110125
Study First Received: October 28, 2011
Results First Received: April 28, 2016
Last Updated: April 6, 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Rutgers, The State University of New Jersey:
Remote Ischemic Preconditioning
Brain death organ donors
Delayed graft function
Donor management
Pulsatile perfusion

ClinicalTrials.gov processed this record on September 21, 2017