Clinical trial NCT03439995: Goal of Open Lung Ventilation in Donors
Official title: Goal of Open Lung Ventilation in Donors
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Brain Death
Organ Donation
Organ Transplant Failure or Rejection
Lead sponsor: Vanderbilt University Medical Center
Sponsor class: OTHER
Collaborators: name: University of California, San Francisco
name: University of California, Los Angeles
name: Stanford University
name: Donor Network West
First posted: 2018-02-20
Enrollment: 154
Sex: ALL
Minimum age (years): 13
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Enrolled donors will be randomly assigned to two different modes of mechanical ventilation for the duration of donor management
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Donor lung utilization rate
timeFrame: during donor management period (usually 12-48 hours)
Secondary outcomes:
measure: Donor lung utilization in likely donors
timeFrame: during donor management period (usually 12-48 hours)
measure: Donor oxygenation
timeFrame: during donor management period (usually 12-48 hours)
measure: Donor static compliance of the respiratory system
timeFrame: during donor management period (usually 12-48 hours)
measure: Donor radiographic atelectasis scoring
timeFrame: during donor management period (usually 12-48 hours)
measure: Recipient primary graft dysfunction
timeFrame: 72 hours after transplant
measure: Recipient mortality
timeFrame: 30 days after transplant
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: UCLA
state: California
city: Palo Alto
country: United States
facility: Stanford University
state: California
city: San Francisco
country: United States
facility: University of California San Francisco
state: California
city: San Ramon
country: United States
facility: Donor Network West
state: California
Study officials:
affiliation: Vanderbilt University Medical Center
name: Lorraine B Ware, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Mascia L, Pasero D, Slutsky AS, Arguis MJ, Berardino M, Grasso S, Munari M, Boifava S, Cornara G, Della Corte F, Vivaldi N, Malacarne P, Del Gaudio P, Livigni S, Zavala E, Filippini C, Martin EL, Donadio PP, Mastromauro I, Ranieri VM. Effect of a lung protective strategy for organ donors on eligibility and availability of lungs for transplantation: a randomized controlled trial. JAMA. 2010 Dec 15;304(23):2620-7. doi: 10.1001/jama.2010.1796.