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Clinical Trial Details — Status: Unknown status

Administrative data

NCT number NCT00260676
Other study ID # 396
Secondary ID
Status Unknown status
Phase Phase 3
First received November 29, 2005
Last updated June 16, 2009
Start date September 2004
Est. completion date January 2010

Study information

Verified date June 2009
Source University of Turin, Italy
Contact luciana mascia, MD PhD
Phone 390116335600
Email luciana.mascia@unito.it
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Unknown status
Enrollment 200
Est. completion date January 2010
Est. primary completion date September 2009
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
change ventilation
reduction of tidal volume, increase of PEEP, recruiting maneuver, apnea test during CPAP

Locations

Country Name City State
Italy University of Turin, Department of Anesthesia and Intensive Care Medicine Turin

Sponsors (2)

Lead Sponsor Collaborator
University of Turin, Italy Ministry of Health, Italy

Country where clinical trial is conducted

Italy, 

Outcome

Type Measure Description Time frame Safety issue
Primary To increase the number of lungs that meet the eligibility criteria for transplantation end of brain death diagnosis observation period
Secondary To increase the number of lungs really transplanted end of brain death diagnosis observation period
Secondary Interim analysis at 100 subjects enrolled will be considered six months after transplant
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