Goal of Open Lung Ventilation in Donors

Therapuetic Areas:Neurology
Age Range:13 - Any
Start Date:July 9, 2018
End Date:December 2021
Contact:Lorraine B Ware, MD
Phone:615 322 3412

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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.

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

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
We found this trial at
Palo Alto, California 94304
Phone: 650-723-6381
Palo Alto, CA
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Los Angeles, California 90095
(310) 825-4321
UCLA UCLA's primary purpose as a public research university is the creation, dissemination, preservation and...
Los Angeles, CA
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San Francisco, California 94143
Phone: 415-353-1210
San Francisco, CA
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San Ramon, California 94583
Phone: 510-529-9458
San Ramon, CA
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