An interventional study of Open lung protective ventilation and Conventional ventilation in Brain Death, Organ Donation and Organ Transplant Failure or Rejection, sponsored by Vanderbilt University Medical Center. Terminated at 4 sites in United States. Open to participants aged 13 Years and older. Per ClinicalTrials.gov, last updated 2021-05-06.
Sponsored by Vanderbilt University Medical Center · Not applicable, Interventional, and Treatment
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 transplantation.
Exclusion Criteria:
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
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
Higher PEEP, lower tidal volume mechanical ventilation
Lower PEEP, standard tidal volume mechanical ventilation
Donor lung utilization rate
Percent of donor lungs procured and transplanted into recipient
Time frame: during donor management period (usually 12-48 hours)
Donor lung utilization in likely donors
Percent of donor lungs used from donors with \< 50 pack year smoking, age \< 65, negative serologies, and no underlying chronic lung disease
Time frame: during donor management period (usually 12-48 hours)
Donor oxygenation
Change in donor arterial oxygen (PaO2) from enrollment to procurement
Time frame: during donor management period (usually 12-48 hours)
Donor static compliance of the respiratory system
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.
Time frame: during donor management period (usually 12-48 hours)
Donor radiographic atelectasis scoring
Change in chest radiograph atelectasis score from enrollment to procurement
Time frame: during donor management period (usually 12-48 hours)
Recipient primary graft dysfunction
International Society of Heart and Lung Transplantation grade 2 or 3 primary graft dysfunction in lung transplant recipient
Time frame: 72 hours after transplant
Recipient mortality
Lung transplant recipient death
Time frame: 30 days after transplant
Plan to share: No
This study is terminated, as verified in May 2021. You cannot join it, but the record below documents what was studied.
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Vanderbilt University Medical Center