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Goal of Open Lung Ventilation in Donors (GOLD)

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ClinicalTrials.gov Identifier: NCT03439995
Recruitment Status : Terminated (Trial no longer feasible)
First Posted : February 20, 2018
Last Update Posted : May 6, 2021
Sponsor:
Collaborators:
University of California, San Francisco
University of California, Los Angeles
Stanford University
Donor Network West
Information provided by (Responsible Party):
Lorraine B. Ware, Vanderbilt University Medical Center

Brief Summary:
The primary goal of this study is to assess whether ventilation of deceased organ donors with an open lung protective ventilatory strategy will improve donor lung utilization rates and donor oxygenation compared to a conventional ventilatory strategy.

Condition or disease Intervention/treatment Phase
Brain Death Organ Donation Organ Transplant Failure or Rejection Other: Open lung protective ventilation Other: Conventional ventilation Not Applicable

Detailed Description:

Deceased organ donors are maintained on life support including mechanical ventilation during the time between brain death and organ procurement. The optimal mode of mechanical ventilation for deceased organ donors has not been definitively established. Since deceased organ donors may develop atelectasis leading to impaired oxygenation, an open lung protective ventilatory strategy with higher positive end expiratory pressure (PEEP), lower tidal volume and recruitment maneuvers has been hypothesized to be beneficial. Favorable outcomes were observed in a European clinical trial comparing open lung protective ventilation (OLPV) to a conventional ventilatory strategy in terms of donor oxygenation and lung utilization for transplantation (Mascia L et al, Journal of the American Medical Association 2010). However, donor management procedures in Europe are much shorter in duration compared to the US and it is not clear that these findings are generalizable to the US donor management environment.

The GOLD trial will test the effect of an OLPV strategy compared to conventional ventilation (CV) in the US donor management environment. This multi center trial will enroll 400 brain dead organ donors randomized into 1 of 2 treatment arms. After randomization, mechanical ventilation will be protocolized according to treatment arm with one arm receiving control ventilation (CV) utilizing standard Donor Network West (DNW) protocols and the other arm receiving the OLPV strategy with higher positive end expiratory pressure (PEEP) and lower tidal volume compared to CV. The primary outcomes is donor lung utilization for transplantation.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 154 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Enrolled donors will be randomly assigned to two different modes of mechanical ventilation for the duration of donor management
Masking: Single (Outcomes Assessor)
Masking Description: Outcomes in donors and lung transplant recipients will be done by assessors who are blinded to ventilator treatment assignment
Primary Purpose: Treatment
Official Title: Goal of Open Lung Ventilation in Donors
Actual Study Start Date : July 9, 2018
Actual Primary Completion Date : January 1, 2020
Actual Study Completion Date : January 1, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Organ Donation

Arm Intervention/treatment
Experimental: Open Lung Protective Ventilation
Volume cycled assist control ventilation with tidal volume 8 cc/kg predicted body weight, PEEP 10 cm water (H2O), recruitment maneuvers every 8 hours and after any ventilator disconnect
Other: Open lung protective ventilation
Higher PEEP, lower tidal volume mechanical ventilation

Active Comparator: Conventional Ventilation
Volume cycled assist control ventilation with tidal volume 10 cc/kg predicted body weight, PEEP 5 cm H2O, recruitment maneuvers after any ventilator disconnect
Other: Conventional ventilation
Lower PEEP, standard tidal volume mechanical ventilation




Primary Outcome Measures :
  1. Donor lung utilization rate [ Time Frame: during donor management period (usually 12-48 hours) ]
    Percent of donor lungs procured and transplanted into recipient


Secondary Outcome Measures :
  1. Donor lung utilization in likely donors [ Time Frame: during donor management period (usually 12-48 hours) ]
    Percent of donor lungs used from donors with < 50 pack year smoking, age < 65, negative serologies, and no underlying chronic lung disease

  2. Donor oxygenation [ Time Frame: during donor management period (usually 12-48 hours) ]
    Change in donor arterial oxygen (PaO2) from enrollment to procurement

  3. Donor static compliance of the respiratory system [ Time Frame: during donor management period (usually 12-48 hours) ]
    Change in compliance of the respiratory system (in ml/cm H2O) from enrollment to procurement. Static compliance (Cstat) is calculated as Cstat = ΔV / Pplat - PEEP where V is the volume delivered by the ventilator, Pplat is the end-inspiratory plateau pressure and PEEP is the level of positive end expiratory pressure.

  4. Donor radiographic atelectasis scoring [ Time Frame: during donor management period (usually 12-48 hours) ]
    Change in chest radiograph atelectasis score from enrollment to procurement

  5. Recipient primary graft dysfunction [ Time Frame: 72 hours after transplant ]
    International Society of Heart and Lung Transplantation grade 2 or 3 primary graft dysfunction in lung transplant recipient

  6. Recipient mortality [ Time Frame: 30 days after transplant ]
    Lung transplant recipient death



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Ages Eligible for Study:   13 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Brain death
  • Authorization for research
  • ≥13 years of age

Exclusion Criteria:

  • Arterial/Inspired oxygen ratio (PaO2/FiO2) ≤ 150 mmHg
  • PaO2/FiO2 ≥ 400 mmHg
  • BMI > 40
  • Hepatitis B surface antigen positive
  • Hepatitis C positive
  • Failure to complete donation process
  • Hemodynamic instability

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): NCT03439995


Locations
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United States, California
UCLA
Los Angeles, California, United States, 90095
Stanford University
Palo Alto, California, United States, 94305
University of California San Francisco
San Francisco, California, United States, 94143
Donor Network West
San Ramon, California, United States, 94583
Sponsors and Collaborators
Vanderbilt University Medical Center
University of California, San Francisco
University of California, Los Angeles
Stanford University
Donor Network West
Investigators
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Principal Investigator: Lorraine B Ware, MD Vanderbilt University Medical Center
Publications:
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Responsible Party: Lorraine B. Ware, Professor of Medicine, Vanderbilt University Medical Center
ClinicalTrials.gov Identifier: NCT03439995    
Other Study ID Numbers: R01HL126176 ( U.S. NIH Grant/Contract )
First Posted: February 20, 2018    Key Record Dates
Last Update Posted: May 6, 2021
Last Verified: May 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Brain Death
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Coma
Unconsciousness
Consciousness Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Death
Pathologic Processes