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CompletedNCT00734266Updated Mar 6, 2013

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

An observational study in Lung Dysfunction and Inflammatory Response During Cardiac Surgery, sponsored by Massachusetts General Hospital. Completed. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2013-03-06.

Sponsored by Massachusetts General Hospital · Observational

Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
20
Ages
18 Years and older
Sex
All
01

Study summary

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.
Read the 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.

02

Conditions studied

  • Lung Dysfunction
  • Inflammatory Response During Cardiac Surgery

Keywords

  • COPD
  • CPB
  • Leukotrienes
03

In context

Lung Diseases, Obstructive

2,592 studies on the registry are indexed under Lung Diseases, Obstructive; 198 are open to participants now.

This study's enrollment of 20 is below the median of 150 across 639 observational studies indexed under Lung Diseases, Obstructive.

Browse Lung Diseases, Obstructive studies →

Lead sponsor

Massachusetts General Hospital is the lead sponsor of 2,536 studies on the registry; 446 are open to participants now.

Of its 214 completed or terminated interventional studies of FDA-regulated products, 161 (75%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

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

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • inability to provide consent;
  • previous diagnosis of asthma;
  • acute pre-operative respiratory failure;
  • emergency surgery.
05

Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
20 participants (actual)

Groups and cohorts

  • 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.

06

What researchers measure

Primary outcomes

  1. urine cysteinyl leukotriene

    Time frame: intra-operative

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 6, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00734266
Lead sponsor
Massachusetts General Hospital
Collaborators
Merck Sharp & Dohme LLC
Responsible party
Marcos Vidal Melo (Associate Professor of Anesthesia, Massachusetts General Hospital) — Principal investigator
First posted
Aug 14, 2008
Start date
Apr 2007
Primary completion
Dec 2010
Completion
Dec 2010
Last update
Mar 6, 2013

Study contacts

Marcos F Vidal Melo, MD
principal investigator · Massachusetts General Hospital

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2013. You cannot join it, but the record below documents what was studied.

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