Changes in Leukotrienes During Cardiac Surgery in Patients With Chronic Obstructive Pulmonary Disease

March 5, 2013 updated by: Marcos Vidal Melo, Massachusetts General Hospital

The hypotheses of this study are that:

  • Production and release of inflammatory substances called leukotrienes are increased during heart surgery with use of a heart-lung machine in humans;
  • The increase in these leukotrienes levels after heart surgery is higher in patients with bronchitis and/or emphysema than in patients without previous history of lung disease;
  • Levels of leukotrienes are directly correlated with worsening of lung function during and after heart surgery.

Study Overview

Status

Completed

Conditions

Detailed Description

In this project, we will test the hypothesis that cys-leukotrienes are released and correlated with the impairment of the lung function after cardiac surgery in patients with COPD. If such hypothesis is substantiated in the study, it would allow us to propose the use of leukotriene inhibitors in the peri-operative period to improve pulmonary function and to decrease complications after cardiac surgery in COPD patients.

Study Type

Observational

Enrollment (Actual)

20

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Adult patients schedules to undergo cardiac surgery with use of CPB.

Description

Inclusion Criteria:

  • Adult patients schedules to undergo cardiac surgery with use of CPB.

Exclusion Criteria:

  • inability to provide consent;
  • previous diagnosis of asthma;
  • acute pre-operative respiratory failure;
  • emergency surgery.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
1 Control
Patients with and without chronic obstructive pulmonary disease diagnosed before scheduling for cardiac surgery.
2 COPD
Patients with and without chronic obstructive pulmonary disease diagnosed before scheduling for cardiac surgery.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
urine cysteinyl leukotriene
Time Frame: intra-operative
intra-operative

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Massachusetts General Hospital

Collaborators

Merck Sharp & Dohme LLC

Investigators

  • Principal Investigator: Marcos F Vidal Melo, MD, Massachusetts General Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2007

Primary Completion (Actual)

December 1, 2010

Study Completion (Actual)

December 1, 2010

Study Registration Dates

First Submitted

August 12, 2008

First Submitted That Met QC Criteria

August 13, 2008

First Posted (Estimate)

August 14, 2008

Study Record Updates

Last Update Posted (Estimate)

March 6, 2013

Last Update Submitted That Met QC Criteria

March 5, 2013

Last Verified

March 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2007-P-000164/7

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Lung Dysfunction

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Malta

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe