Changes in Leukotrienes During Cardiac Surgery in Patient... | NCT00734266

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

NCT00734266

Sponsor

Massachusetts General Hospital

Status

Completed

Last Update Posted

Mar 6, 2013Estimated

Enrollment

20Actual

Phase

Not provided

Conditions

Lung Dysfunction
Inflammatory Response During Cardiac Surgery

Interventions

Not provided

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2013

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2007

Primary Completion Date

Dec 2010Actual

Completion Date

Dec 2010Actual

First Submitted Date

Aug 12, 2008

First Submission Date that Met QC Criteria

Aug 13, 2008

First Posted Date

Aug 14, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 5, 2013

Last Update Posted Date

Mar 6, 2013Estimated

Name	Class
Merck Sharp & Dohme LLC	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

20Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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.

Interventions

Not provided

Measure	Description	Time Frame
urine cysteinyl leukotriene		intra-operative

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Marcos F Vidal Melo, MD	Massachusetts General Hospital	Principal Investigator

Locations

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D029424	Pulmonary Disease, Chronic Obstructive

Ancestor Terms

ID	Term
D008173	Lung Diseases, Obstructive
D008171	Lung Diseases
D012140	Respiratory Tract Diseases
D002908	Chronic Disease

Browse Leaves

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Browse Branches

Not provided