NCT00734266

Brief 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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Apr 2007

Typical duration for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2007

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

August 12, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 14, 2008

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2010

Completed
Last Updated

March 6, 2013

Status Verified

March 1, 2013

Enrollment Period

3.7 years

First QC Date

August 12, 2008

Last Update Submit

March 5, 2013

Conditions

Lung DysfunctionInflammatory Response During Cardiac Surgery

Keywords

COPDCPBLeukotrienes

Outcome Measures

Primary Outcomes (1)

  • urine cysteinyl leukotriene

    intra-operative

Study Arms (2)

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.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Marcos F Vidal Melo, MD

    Massachusetts General Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Anesthesia

Study Record Dates

First Submitted

August 12, 2008

First Posted

August 14, 2008

Study Start

April 1, 2007

Primary Completion

December 1, 2010

Study Completion

December 1, 2010

Last Updated

March 6, 2013

Record last verified: 2013-03