Levosimendan Pretreatment for Weaning Patients From Cardi... | NCT00130871

Studies
Levosimendan Pretreatment for Weaning Patients From Cardio-Pulmonary Bypass

NCT00130871

Sponsor

Orion Corporation, Orion Pharma

Status

Completed

Last Update Posted

Feb 21, 2007Estimated

Enrollment

Phase

Phase 2

Conditions

Coronary Heart Disease

Interventions

levosimendan

Countries

Finland

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

Feb 2007

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

Jan 2004

Primary Completion Date

Not provided

Completion Date

Jan 2006

First Submitted Date

Aug 15, 2005

First Submission Date that Met QC Criteria

Aug 15, 2005

First Posted Date

Aug 16, 2005Estimated

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

Feb 19, 2007

Last Update Posted Date

Feb 21, 2007Estimated

Description Module

Brief Summary

The study evaluates the efficacy of intravenous levosimendan treatment started during a coronary artery bypass operation to wean patients from a heart lung machine.

Detailed Description

Levosimendan or placebo infusion is started at the time of induction of anesthesia.

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 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

Name	Type	Description	Arm Group Labels	Other Names
levosimendan	Drug

Measure	Description	Time Frame
Proportion of successful primary weanings

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Three vessel coronary artery disease.
Indication for on-pump coronary artery bypass surgery.
Ejection fraction below 50%

Exclusion Criteria:

Indication for any cardiac valve surgery
Previous coronary artery bypass 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

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Markku Salmenperä, MD	Helsinki University Central Hospital, Finland	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Helsinki University Central Hospital		Helsinki		00290	Finland
Turku University Central Hospital

Condition Browse Module

MeSH Terms

ID	Term
D003327	Coronary Disease

Ancestor Terms

ID	Term
D017202	Myocardial Ischemia
D006331	Heart Diseases
D002318	Cardiovascular Diseases
D014652	Vascular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000077464	Simendan

Ancestor Terms

ID	Term
D006835	Hydrazones
D006834	Hydrazines
D009930	Organic Chemicals
D011724	Pyridazines

Browse Leaves

Not provided

Browse Branches

Not provided