Skip to main content

Summary

for people ages 13 years and up (full criteria)
study started
estimated completion:

Description

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.

Details

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.

Keywords

Brain Death Organ Donation Organ Transplant Failure or Rejection

Eligibility

You can join if…

Open to people ages 13 years and up

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

You CAN'T join if...

  • 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

Details

Status
not yet accepting patients
Start Date
Completion Date
(estimated)
Sponsor
Vanderbilt University Medical Center
ID
NCT03439995
Study Type
Interventional
Last Updated
February 24, 2018
I’m interested in this study!