Clinical Trial: The Use of Surfactant in Lung Transplantation: A Randomized Control Pilot Study
Study Status: Recruiting
Recruit Status: Unknown status
Study Type: Interventional
Official Title: The Use of Surfactant in Lung Transplantation: A Randomized Control Pilot Study
Brief Summary:
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Working Hypothesis:
The purpose of the trial is to study the effect of exogenous calf surfactant (calfactant) on the prevention of primary graft failure due to ischemic-reperfusion lung injury in lung transplant patients.
- Aims of the Study:
The purpose of the trial is to study the effect of exogenous calf surfactant (calfactant) on the prevention of primary graft failure due to ischemic-reperfusion lung injury in lung transplant patients.
Detailed Summary:
Background: Lung transplantation induces surfactant dysfunction that may be a contributing factor for primary graft dysfunction (PGD) and graft failure. Animal studies and limited human reports suggest that surfactant administration may prevent primary graft dysfunction.
Working hypothesis and aims:
The purpose of the trial is to study the effect of exogenous calf surfactant (calfactant) on the prevention of primary graft failure due to ischemic-reperfusion lung injury in lung transplant patients.
Methods: The trial is an open randomized controlled prospective study. Patient population: 42 patients eligible for lung transplant according to hospital criteria.
Study medication: Calfactant intratracheal suspension -an extract of natural surfactant from calf lungs, which includes phospholipids, neutral lipids and surfactant-associated proteins B and C (SP-B and SP-C).
Study design: Patients randomized to receive calfactant will have the drug administered through a fiberoptic bronchoscope distributing the drug evenly across the lung immediately after connection. The other patient will not have any administration to avoid any excessive flushing. When 2 lungs will be used from the same donor for 2 recipients one patient receiving one lung will be treated with calfactant while the other patient receiving the other lung will not be treated and serve as the control. Otherwise lungs will be treated with surfactant in every other case.
Expected results: We expect surfactant instillation during lung transplantation to improve oxygenation, prevent primary graft dysfunction, make intubation time shorter and to enhance early post transplantat
Sponsor: Rabin Medical Center
Current Primary Outcome: Effect of intraoperative exogenous surfactant treatment on oxygenation and primary graft dysfunction (PGD) prevention (primary outcome) [ Time Frame: 3 days post operation ]
Original Primary Outcome: Same as current
Current Secondary Outcome: Recovery-Extubation ;Seating time; Icu stay; Hospital stay; Lung function [ Time Frame: 1 month ]
Original Secondary Outcome: Same as current
Information By: Rabin Medical Center
Dates:
Date Received: July 15, 2007
Date Started: January 2005
Date Completion: December 2008
Last Updated: July 23, 2007
Last Verified: July 2007
