GOLD: Goal of Open Lung Ventilation in Donors

• Sponsor: Vanderbilt University Medical Center (Other)
• Overall Status: Terminated
• CT.gov ID: NCT03439995
• Collaborator: University of California, San Francisco (Other), University of California, Los Angeles (Other), Stanford University (Other), Donor Network West (Other)
• Enrollment: 154
• Locations: 4
• Arms: 2
• Actual Duration (Months): 29.8
• Patients Per Site: 38.5
• Patients Per Site Per Month: 1.3

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Brain Death; Organ Donation; Organ Transplant Failure or Rejection	Other: Open lung protective ventilation; Other: Conventional ventilation	N/A

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 154 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Enrolled donors will be randomly assigned to two different modes of mechanical ventilation for the duration of donor managementEnrolled donors will be randomly assigned to two different modes of mechanical ventilation for the duration of donor management
• Masking: Single (Outcomes Assessor)
• Masking Description: Outcomes in donors and lung transplant recipients will be done by assessors who are blinded to ventilator treatment assignment
• Primary Purpose: Treatment
• Official Title: Goal of Open Lung Ventilation in Donors
• Actual Study Start Date: Jul 9, 2018
• Actual Primary Completion Date: Jan 1, 2020
• Actual Study Completion Date: Jan 1, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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	Other: Open lung protective ventilation; Higher PEEP, lower tidal volume mechanical ventilation
Active Comparator: 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	Other: Conventional ventilation; Lower PEEP, standard tidal volume mechanical ventilation

Outcome Measures

Primary Outcome Measures

1. Donor lung utilization rate [during donor management period (usually 12-48 hours)]

   Percent of donor lungs procured and transplanted into recipient

Secondary Outcome Measures

1. 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

2. Donor oxygenation [during donor management period (usually 12-48 hours)]

   Change in donor arterial oxygen (PaO2) from enrollment to procurement

3. 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.

4. Donor radiographic atelectasis scoring [during donor management period (usually 12-48 hours)]

   Change in chest radiograph atelectasis score from enrollment to procurement

5. 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

6. Recipient mortality [30 days after transplant]

   Lung transplant recipient death

Eligibility Criteria

Criteria

• Ages Eligible for Study: 13 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	UCLA	Los Angeles	California	United States	90095
2	Stanford University	Palo Alto	California	United States	94305
3	University of California San Francisco	San Francisco	California	United States	94143
4	Donor Network West	San Ramon	California	United States	94583

Sponsors and Collaborators

• Vanderbilt University Medical Center
• University of California, San Francisco
• University of California, Los Angeles
• Stanford University
• Donor Network West

Investigators

• Principal Investigator: Lorraine B Ware, MD, Vanderbilt University Medical Center

Study Documents (Full-Text)

None provided.

More Information

Publications

• 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.

• Responsible Party: Lorraine B. Ware, Professor of Medicine, Vanderbilt University Medical Center
• ClinicalTrials.gov Identifier: NCT03439995
• Other Study ID Numbers: R01HL126176
• First Posted: Feb 20, 2018
• Last Update Posted: May 6, 2021
• Last Verified: May 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Brain Death

Study Results

No Results Posted as of May 6, 2021