Goal of Open Lung Ventilation in Donors

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

154 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-07-09

Study Completion Date

2021-01-01

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Brain Death Organ Donation Organ Transplant Failure or Rejection

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Enrolled donors will be randomly assigned to two different modes of mechanical ventilation for the duration of donor management

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Outcomes in donors and lung transplant recipients will be done by assessors who are blinded to ventilator treatment assignment

Study Groups

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Open Lung Protective Ventilation

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

Group Type EXPERIMENTAL

Open lung protective ventilation

Intervention Type OTHER

Higher PEEP, lower tidal volume mechanical ventilation

Conventional 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

Group Type ACTIVE_COMPARATOR

Conventional ventilation

Intervention Type OTHER

Lower PEEP, standard tidal volume mechanical ventilation

Interventions

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Open lung protective ventilation

Higher PEEP, lower tidal volume mechanical ventilation

Intervention Type OTHER

Conventional ventilation

Lower PEEP, standard tidal volume mechanical ventilation

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

13 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No