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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2007 by Rabin Medical Center.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Rabin Medical Center
ClinicalTrials.gov Identifier:
NCT00506532
First received: July 15, 2007
Last updated: July 23, 2007
Last verified: July 2007
  Purpose
  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.


Condition Intervention Phase
Lung Transplantation
Primary Graft Dysfunction
Drug: Surfactant (calfactant)
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: The Use of Surfactant in Lung Transplantation: A Randomized Control Pilot Study

Resource links provided by NLM:


Further study details as provided by Rabin Medical Center:

Primary Outcome Measures:
  • Effect of intraoperative exogenous surfactant treatment on oxygenation and primary graft dysfunction (PGD) prevention (primary outcome) [ Time Frame: 3 days post operation ]

Secondary Outcome Measures:
  • Recovery-Extubation ;Seating time; Icu stay; Hospital stay; Lung function [ Time Frame: 1 month ]

Estimated Enrollment: 42
Study Start Date: January 2005
Estimated Study Completion Date: December 2008
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

Ages Eligible for Study:   16 Years to 68 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Candidates for lung transplantation

Exclusion Criteria:

  • Differential diagnosis of PGD
  • Pulmonary Edema
  • Stenosis or thrombosis of pulmonary artery/vein anastomosis
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00506532

Contacts
Contact: Mordechai R Kramer, Prof 972-3-9377121 kremerm@clalit.org.il
Contact: Anat Amital, Dr 972-3-9377140 anatam@clalit.org.il

Locations
Israel
Pulmonary Institute Rabin Medical Center Recruiting
Petach Tikva, Israel, 49100
Contact: Mordechai R kramer, prof    972-3-9377221    kremerm@clalit.org.il   
Sub-Investigator: Anat Amital, Dr         
Sub-Investigator: David Shitrit, Dr         
Sub-Investigator: Ilana Bakal         
Sub-Investigator: Yael Raviv, Dr         
Sponsors and Collaborators
Rabin Medical Center
Investigators
Principal Investigator: MordechaI R Kramer, Prof Pulmonary Institute Rabin Medical Center
Principal Investigator: Mordechai R Kramer, Prof Pulmonary Institute Rabin Medical Center
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00506532     History of Changes
Other Study ID Numbers: RMC063344ctil
Study First Received: July 15, 2007
Last Updated: July 23, 2007
Health Authority: United States: Institutional Review Board

Keywords provided by Rabin Medical Center:
Pulmonary Surfactants
Lung transplantation
Primary Graft Dysfunction

Additional relevant MeSH terms:
Primary Graft Dysfunction
Cardiovascular Diseases
Pathologic Processes
Postoperative Complications
Reperfusion Injury
Vascular Diseases
Pulmonary Surfactants
Pharmacologic Actions
Respiratory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014