Brain Death, Organ Donation, Organ Transplant Failure or Rejection
Conditions
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.
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.
Interventions
OTHEROpen lung protective ventilation
Higher PEEP, lower tidal volume mechanical ventilation
Lower PEEP, standard tidal volume mechanical ventilation
Sponsors
University of California, San Francisco
University of California, Los Angeles
Stanford University
Donor Network West
Vanderbilt University Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
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
Intervention model description
Enrolled donors will be randomly assigned to two different modes of mechanical ventilation for the duration of donor management
Eligibility
Sex/Gender
ALL
Age
13 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Donor lung utilization rate | during donor management period (usually 12-48 hours) | Percent of donor lungs procured and transplanted into recipient |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Donor oxygenation | during donor management period (usually 12-48 hours) | Change in donor arterial oxygen (PaO2) from enrollment to procurement |
| Donor static compliance of the respiratory system | 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. |
| Donor lung utilization in likely donors | 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 |
| Recipient primary graft dysfunction | 72 hours after transplant | International Society of Heart and Lung Transplantation grade 2 or 3 primary graft dysfunction in lung transplant recipient |
| Recipient mortality | 30 days after transplant | Lung transplant recipient death |
| Donor radiographic atelectasis scoring | during donor management period (usually 12-48 hours) | Change in chest radiograph atelectasis score from enrollment to procurement |
Countries
United States
Outcome results
None listed