Clinical trial NCT00260676: Protective Ventilatory Strategy in Potential Organ Donors
Official title: a Randomised Control Trial on Protective Ventilatory Strategy in Potential Organ Donors
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Mechanical Ventilation
Keywords: brain death
lung transplantation
organ donors
potential organ donors
Lead sponsor: University of Turin, Italy
Sponsor class: OTHER
Collaborators: name: Ministry of Health, Italy
First posted: 2005-12-01
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of the study is to verify if a "PROTECTIVE" ventilatory strategy (low tidal volume and high PEEP, application of CPAP during the apnea test and recruitment maneuvers), improves lung function and increases the number of lungs eligible for transplantation.

Detailed description: Lung transplantation reduces mortality in patients with severe pulmonary diseases. While 50-70% of kidney, liver and heart are eligible for transplantation, only 20% of the lungs fit the criteria for transplant. More than 30% of the lungs theoretically suitable for donation are not actually collected because following brain death they develop severe hypoxemia and abnormal chest X-ray. Guidelines for critical care management of potential organ donors suggest that after the diagnosis of brain death, treatment priority can be shifted from cerebral protection to a strategy aimed at preserving solid organ perfusion and function. However the ventilatory strategy recommended for potential lung donors is similar to the one proposed for brain injured patients. This ventilatory strategy based on high Vt and low PEEP may induce a further exacerbation of the pulmonary and systemic inflammatory response in patients with acute lung injury/acute respiratory distress syndrome. Moreover, recent data suggest that this strategy may be harmful in "normal lungs" of mechanical ventilated patients. Aim of the study is to verify if a "PROTECTIVE" ventilatory strategy (low tidal volume and high PEEP, application of CPAP during the apnea test and recruitment maneuvers) improves lung function. Primary end point of the study is to increase the number of lungs that meet the eligibility criteria for transplantation. Secondary end point is to increase the number of lungs really transplanted.

Eligibility criteria: Inclusion Criteria:

* Age: 18-65 years
* Chest X-ray: no infiltrates
* Duration of mechanical ventilation from the admission to ICU to the clinical diagnosis of brain death \< 5 days
* No history of Smoking (1 pack/day for 20 years; 1/2 pack/day for 40 years; 2 packs/day for 10 years)
* No history of Asthma
* No history of COPD
* No history of Trauma
* No history of Thoracic surgery

Exclusion Criteria:

* Evidence of aspiration (chest X-ray or bronchoscopy) or sepsis
* Purulent secretions (tracheal suction or bronchoscopy)
* Sputum Gram stain with bacteria, fungus, significant number of WBC

Primary outcomes:
measure: To increase the number of lungs that meet the eligibility criteria for transplantation
timeFrame: end of brain death diagnosis observation period
Secondary outcomes:
measure: To increase the number of lungs really transplanted
timeFrame: end of brain death diagnosis observation period
measure: Interim analysis at 100 subjects enrolled will be considered
timeFrame: six months after transplant
Other outcomes:
Locations:
city: Turin
country: Italy
facility: University of Turin, Department of Anesthesia and Intensive Care Medicine
Study officials:
affiliation: University of Turin, Italy
name: luciana mascia, MD PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Turin, Italy
name: marco ranieri, MD
role: STUDY_DIRECTOR
References:
citation: 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.