Levosimendan Versus Dobutamine in Cardiopatic Patients Un... | NCT02012946

Studies
Levosimendan Versus Dobutamine in Cardiopatic Patients Undergoing Major Non Cardiac Surgery

NCT02012946

Sponsor

Azienda Policlinico Umberto I

Status

Unknown status

Last Update Posted

Dec 17, 2013Estimated

Enrollment

40Estimated

Phase

Phase 4

Conditions

Cardiovascular Diseases

Interventions

Levosimendan
Dobutamine

Countries

Italy

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

Dec 2013

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2013

Primary Completion Date

Dec 2013Actual

Completion Date

Not provided

First Submitted Date

Dec 11, 2013

First Submission Date that Met QC Criteria

Dec 11, 2013

First Posted Date

Dec 17, 2013Estimated

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

Dec 11, 2013

Last Update Posted Date

Dec 17, 2013Estimated

Description Module

Brief Summary

This study wants to investigate the hemodynamic changes in cardiopatic patients undergoing major non cardiac surgery, during and after the continuous infusion of levosimendan or dobutamine.

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

Biospecimen

No data available

No data is available for this block.

Enrollment

40Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
dobutamine	Active Comparator	patient receiving dobutamine	Drug: Dobutamine
Levosimendan	Active Comparator	patient receiving levosimendan	Drug: Levosimendan

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Levosimendan	Drug	patient receiving levosimendan	Levosimendan
Dobutamine

Measure	Description	Time Frame
cardiac index		1-3 days

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

EF < 40%, no liver and renal disfynction, chronic cardiopathy

Exclusion Criteria:

acute coronary syndrome, life expectation <30 days, hemodialysis, ventricular tachycardia/ventricular fibrillation

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

85 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Francesco Pugliese		Rome	Rome	00100	Italy

Condition Browse Module

MeSH Terms

ID	Term
D002318	Cardiovascular Diseases

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000077464	Simendan
D004280	Dobutamine

Ancestor Terms

ID	Term
D006835	Hydrazones
D006834	Hydrazines
D009930	Organic Chemicals
D011724	Pyridazines

Browse Leaves

Not provided

Browse Branches

Not provided