Clinical trial NCT00506532: The Use of Surfactant in Lung Transplantation: A Randomized Control Pilot Study
Official title: The Use of Surfactant in Lung Transplantation: A Randomized Control Pilot Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: Lung Transplantation
Primary Graft Dysfunction
Keywords: Pulmonary Surfactants
Lung transplantation
Primary Graft Dysfunction
Lead sponsor: Rabin Medical Center
Sponsor class: OTHER
First posted: 2007-07-25
Enrollment: 42
Sex: ALL
Minimum age (years): 16
Maximum age (years): 68
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

Detailed 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.

Eligibility criteria: Inclusion Criteria:

* Candidates for lung transplantation

Exclusion Criteria:

* Differential diagnosis of PGD
* Pulmonary Edema
* Stenosis or thrombosis of pulmonary artery/vein anastomosis

Primary outcomes:
measure: Effect of intraoperative exogenous surfactant treatment on oxygenation and primary graft dysfunction (PGD) prevention (primary outcome)
timeFrame: 3 days post operation
Secondary outcomes:
measure: Recovery-Extubation ;Seating time; Icu stay; Hospital stay; Lung function
timeFrame: 1 month
Other outcomes:
Locations:
city: Petach Tikva
country: Israel
facility: Pulmonary Institute Rabin Medical Center
Study officials:
affiliation: Pulmonary Institute Rabin Medical Center
name: MordechaI R Kramer, Prof
role: PRINCIPAL_INVESTIGATOR
References: