Goal of Open Lung Ventilation in Donors (GOLD)

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.

Study Overview

• Status: Terminated
• Conditions: Brain Death; Organ Donation; Organ Transplant Failure or Rejection
• Intervention / Treatment: Other: Open lung protective ventilation; Other: Conventional ventilation

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 Type: Interventional
• Enrollment (Actual): 154
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90095
      • UCLA
    • Palo Alto, California, United States, 94305
      • Stanford University
    • San Francisco, California, United States, 94143
      • University of California San Francisco
    • San Ramon, California, United States, 94583
      • Donor Network West

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 13 years and older (ADULT, OLDER_ADULT, CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Vanderbilt University Medical Center
• Collaborators: University of California, Los Angeles; University of California, San Francisco; Stanford University; Donor Network West
• Investigators: Principal Investigator: Lorraine B Ware, MD, Vanderbilt University Medical Center

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): July 9, 2018
• Primary Completion (ACTUAL): January 1, 2020
• Study Completion (ACTUAL): January 1, 2021

Study Registration Dates

• First Submitted: February 14, 2018
• First Submitted That Met QC Criteria: February 14, 2018
• First Posted (ACTUAL): February 20, 2018

Study Record Updates

• Last Update Posted (ACTUAL): May 6, 2021
• Last Update Submitted That Met QC Criteria: May 3, 2021
• Last Verified: May 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Neurobehavioral Manifestations; Death; Unconsciousness; Consciousness Disorders; Coma; Brain Death
• Other Study ID Numbers: R01HL126176 (NIH)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No