The Use of Surfactant in Lung Transplantation: A Randomized Control Pilot Study

Lung Transplantation Clinical Trial

Official title:

The Use of Surfactant in Lung Transplantation: A Randomized Control Pilot Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00506532
• Other study ID #: RMC063344ctil
• Status: Recruiting
• Phase: Phase 2/Phase 3
• First received: July 15, 2007
• Last updated: July 23, 2007
• Start date: January 2005
• Est. completion date: December 2008

Study information

• Verified date: July 2007
• Source: Rabin Medical Center
• Contact: Mordechai R Kramer, Prof
• Phone: 972-3-9377121
• Email: kremerm[@]clalit.org.il
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

1. 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.

2. 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.

Description:

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 transplantation recovery. In a pilot study that we already performed results are encouraging.

Importance: PGD could cause substantial morbidity and mortality among transplanted patients. In a pilot study we already found that surfactant instillation during lung transplantation improves oxygenation, prevents primary graft dysfunction, shortens intubation time and ICU stay. We believe that surfactant treatment enhances early post transplantation recovery, and may also be cost effective by shortening expensive ICU stay.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 42
• Est. completion date: December 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 16 Years to 68 Years

Eligibility

Inclusion Criteria:

• Candidates for lung transplantation

Exclusion Criteria:

• Differential diagnosis of PGD

• Pulmonary Edema

• Stenosis or thrombosis of pulmonary artery/vein anastomosis

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Lung Transplantation
• Primary Graft Dysfunction

Intervention

Drug:
• Surfactant (calfactant)

Locations

Country	Name	City	State
Israel	Pulmonary Institute Rabin Medical Center	Petach Tikva

Sponsors (1)

Lead Sponsor	Collaborator
Rabin Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Effect of intraoperative exogenous surfactant treatment on oxygenation and primary graft dysfunction (PGD) prevention (primary outcome)		3 days post operation
Secondary	Recovery-Extubation ;Seating time; Icu stay; Hospital stay; Lung function		1 month