Goal of Open Lung Ventilation in Donors

Brain Death Clinical Trial

— GOLD  

Official title:

Goal of Open Lung Ventilation in Donors

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03439995
• Other study ID #: R01HL126176
• Status: Terminated
• Phase: N/A
• Start date: July 9, 2018
• Est. completion date: January 1, 2021

Study information

• Verified date: May 2021
• Source: Vanderbilt University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 154
• Est. completion date: January 1, 2021
• Est. primary completion date: January 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 13 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Brain Death
• Organ Donation
• Organ Transplant Failure or Rejection

Intervention

Other:
• Open lung protective ventilation
Higher PEEP, lower tidal volume mechanical ventilation
• Conventional ventilation
Lower PEEP, standard tidal volume mechanical ventilation

Locations

Country	Name	City	State
United States	UCLA	Los Angeles	California
United States	Stanford University	Palo Alto	California
United States	University of California San Francisco	San Francisco	California
United States	Donor Network West	San Ramon	California

Sponsors (5)

Lead Sponsor	Collaborator
Vanderbilt University Medical Center	Donor Network West, Stanford University, University of California, Los Angeles, University of California, San Francisco

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Donor lung utilization rate	Percent of donor lungs procured and transplanted into recipient	during donor management period (usually 12-48 hours)
Secondary	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)
Secondary	Donor oxygenation	Change in donor arterial oxygen (PaO2) from enrollment to procurement	during donor management period (usually 12-48 hours)
Secondary	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 = ?V / 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)
Secondary	Donor radiographic atelectasis scoring	Change in chest radiograph atelectasis score from enrollment to procurement	during donor management period (usually 12-48 hours)
Secondary	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
Secondary	Recipient mortality	Lung transplant recipient death	30 days after transplant