Goal of Open Lung Ventilation in Donors (GOLD)

Vanderbilt University Medical Center

Status: Terminated

Conditions: Organ Donation; Organ Transplant Failure or Rejection; Brain Death

Treatments: Other: Conventional ventilation; Other: Open lung protective ventilation

Study type: Interventional

Funder types: Other

Identifiers

NCT03439995

R01HL126176

Details and patient eligibility

About

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.

Full 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.

Enrollment: 154 patients

Sex: All

Ages: 13+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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154 participants in 2 patient groups

Open Lung Protective Ventilation

Experimental group

Description:

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

Treatment:

Other: Open lung protective ventilation

Conventional Ventilation

Active Comparator group

Description:

Volume cycled assist control ventilation with tidal volume 10 cc/kg predicted body weight, PEEP 5 cm H2O, recruitment maneuvers after any ventilator disconnect

Treatment:

Other: Conventional ventilation