Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Protective Ventilatory Strategy in Potential Organ Donors

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2009 by University of Turin, Italy.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Ministry of Health, Italy
Information provided by:
University of Turin, Italy
ClinicalTrials.gov Identifier:
NCT00260676
First received: November 29, 2005
Last updated: June 16, 2009
Last verified: June 2009
  Purpose

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.


Condition Intervention Phase
Mechanical Ventilation
Procedure: change ventilation
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: a Randomised Control Trial on Protective Ventilatory Strategy in Potential Organ Donors

Further study details as provided by University of Turin, Italy:

Primary Outcome Measures:
  • To increase the number of lungs that meet the eligibility criteria for transplantation [ Time Frame: end of brain death diagnosis observation period ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To increase the number of lungs really transplanted [ Time Frame: end of brain death diagnosis observation period ] [ Designated as safety issue: No ]
  • Interim analysis at 100 subjects enrolled will be considered [ Time Frame: six months after transplant ] [ Designated as safety issue: No ]

Estimated Enrollment: 200
Study Start Date: September 2004
Estimated Study Completion Date: January 2010
Estimated Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
conventional ventilation, protective ventilation Procedure: change ventilation
reduction of tidal volume, increase of PEEP, recruiting maneuver, apnea test during CPAP

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

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00260676

Contacts
Contact: luciana mascia, MD PhD 390116335600 luciana.mascia@unito.it
Contact: daniela pasero, MD 390116334002 dpasero@molinette.piemonte.it

Locations
Italy
University of Turin, Department of Anesthesia and Intensive Care Medicine Recruiting
Turin, Italy, 10126
Principal Investigator: Luciana Mascia, MD PhD         
Sponsors and Collaborators
University of Turin, Italy
Ministry of Health, Italy
Investigators
Principal Investigator: luciana mascia, MD PhD University of Turin
Study Director: marco ranieri, MD University of Turin
  More Information

No publications provided by University of Turin, Italy

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Luciana Mascia, University of Turin, Italy
ClinicalTrials.gov Identifier: NCT00260676     History of Changes
Other Study ID Numbers: 396
Study First Received: November 29, 2005
Last Updated: June 16, 2009
Health Authority: Italy: Ministry of Health

Keywords provided by University of Turin, Italy:
brain death
lung transplantation
organ donors
potential organ donors

ClinicalTrials.gov processed this record on November 20, 2014