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Protective Ventilatory Strategy in Potential Organ Donors

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00260676
Recruitment Status : Unknown
Verified June 2009 by University of Turin, Italy.
Recruitment status was:  Recruiting
First Posted : December 1, 2005
Last Update Posted : June 17, 2009
Sponsor:
Collaborator:
Ministry of Health, Italy
Information provided by:
University of Turin, Italy

Tracking Information
First Submitted Date  ICMJE November 29, 2005
First Posted Date  ICMJE December 1, 2005
Last Update Posted Date June 17, 2009
Study Start Date  ICMJE September 2004
Estimated Primary Completion Date September 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 5, 2009)
To increase the number of lungs that meet the eligibility criteria for transplantation [ Time Frame: end of brain death diagnosis observation period ]
Original Primary Outcome Measures  ICMJE
 (submitted: November 29, 2005)
To increase the number of lungs that meet the eligibility criteria for transplantation
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 16, 2009)
  • To increase the number of lungs really transplanted [ Time Frame: end of brain death diagnosis observation period ]
  • Interim analysis at 100 subjects enrolled will be considered [ Time Frame: six months after transplant ]
Original Secondary Outcome Measures  ICMJE
 (submitted: November 29, 2005)
To increase the number of lungs really transplanted
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Protective Ventilatory Strategy in Potential Organ Donors
Official Title  ICMJE a Randomised Control Trial on Protective Ventilatory Strategy in Potential Organ Donors
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Mechanical Ventilation
Intervention  ICMJE Procedure: change ventilation
reduction of tidal volume, increase of PEEP, recruiting maneuver, apnea test during CPAP
Study Arms  ICMJE conventional ventilation, protective ventilation
Intervention: Procedure: change ventilation
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: November 29, 2005)
200
Original Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE January 2010
Estimated Primary Completion Date September 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Italy
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00260676
Other Study ID Numbers  ICMJE 396
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Luciana Mascia, University of Turin, Italy
Study Sponsor  ICMJE University of Turin, Italy
Collaborators  ICMJE Ministry of Health, Italy
Investigators  ICMJE
Principal Investigator: luciana mascia, MD PhD University of Turin, Italy
Study Director: marco ranieri, MD University of Turin, Italy
PRS Account University of Turin, Italy
Verification Date June 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP