Goal of Open Lung Ventilation in Donors

Not Applicable

Terminated

• Conditions: Brain Death; Organ Donation; Organ Transplant Failure or Rejection
• Interventions: Other: Conventional ventilation; Other: Open lung protective ventilation

• Registration Number: NCT03439995
• Lead Sponsor: Vanderbilt University Medical Center

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.

Basic Information
|
Recruitment & Eligibility
|
Study & Design
|
Trial Locations

Study Timeline

• Study First Submitted: 2018-02-14
• Study First Submitted QC: 2018-02-14
• Study First Posted: 2018-02-20
• Study Start: 2018-07-09
• Primary Completion: 2020-01-01
• Study Completion: 2021-01-01
• Status Verified: 2021-05
• Last Update Submitted: 2021-05-03
• Last Update Posted: 2021-05-06

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 154

Inclusion Criteria

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

Read More

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Conventional 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
Open Lung Protective Ventilation	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

Primary Outcome Measures

Name	Time	Method
Donor lung utilization rate	during donor management period (usually 12-48 hours)	Percent of donor lungs procured and transplanted into recipient

Secondary Outcome Measures

Name	Time	Method
Donor lung utilization in likely donors	during donor management period (usually 12-48 hours)	Percent of donor lungs used from donors with \< 50 pack year smoking, age \< 65, negative serologies, and no underlying chronic lung disease
Donor oxygenation	during donor management period (usually 12-48 hours)	Change in donor arterial oxygen (PaO2) from enrollment to procurement
Donor static compliance of the respiratory system	during donor management period (usually 12-48 hours)	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.
Donor radiographic atelectasis scoring	during donor management period (usually 12-48 hours)	Change in chest radiograph atelectasis score from enrollment to procurement
Recipient primary graft dysfunction	72 hours after transplant	International Society of Heart and Lung Transplantation grade 2 or 3 primary graft dysfunction in lung transplant recipient
Recipient mortality	30 days after transplant	Lung transplant recipient death

Trial Locations

Locations (4)

Stanford University; 🇺🇸 Palo Alto, California, United States

Donor Network West; 🇺🇸 San Ramon, California, United States

University of California San Francisco; 🇺🇸 San Francisco, California, United States

UCLA; 🇺🇸 Los Angeles, California, United States