Effects of N-acetylcysteine on Pulmonary Function in High... | NCT01021163

Studies
Effects of N-acetylcysteine on Pulmonary Function in High-risk Patients Undergoing Off-pump Coronary Bypass Surgery

NCT01021163

Sponsor

Yonsei University

Status

Completed

Last Update Posted

Nov 26, 2009Estimated

Enrollment

48Actual

Phase

Phase 4

Conditions

Coronary Artery Occlusion

Interventions

N-acetylcysteine, saline

Countries

South Korea

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

Nov 2009

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

Not provided

Primary Completion Date

Not provided

Completion Date

Not provided

First Submitted Date

Nov 25, 2009

First Submission Date that Met QC Criteria

Nov 25, 2009

First Posted Date

Nov 26, 2009Estimated

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

Nov 25, 2009

Last Update Posted Date

Nov 26, 2009Estimated

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 purpose of this study is to study the effects of N-acetylcysteine on pulmonary function in high-risk patients undergoing off-pump coronary bypass surgery.

Detailed Description

Not provided

Design Module

Study Type

Interventional

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

Phase 4

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

48Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
N-acetylcysteine , saline	Placebo Comparator		Drug: N-acetylcysteine, saline

Interventions

Name	Type	Description	Arm Group Labels	Other Names
N-acetylcysteine, saline	Drug	Inject 100 mg/kg of N-acetylcysteine or the equivalent amount of saline for 15 minutes before the skin incision, then continuously inject 40 mg/kg/day of N-acetylcysteine or the equivalent amount of saline during the next 24 hours.

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Adult patients with Euroscore ≥ 5

Exclusion Criteria:

Patients in need of emergency surgery,acute renal failure patients, kidney transplanted patients, patients injected with NAC 5days before planned surgery

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D054059	Coronary Occlusion

Ancestor Terms

ID	Term
D003327	Coronary Disease
D017202	Myocardial Ischemia
D006331	Heart Diseases
D002318	Cardiovascular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000111	Acetylcysteine
D012965	Sodium Chloride

Ancestor Terms

ID	Term
D003545	Cysteine
D000603	Amino Acids, Sulfur
D013457	Sulfur Compounds
D009930	Organic Chemicals

Browse Leaves

Not provided

Browse Branches

Not provided