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Levosimendan Versus Dobutamine in Cardiopatic Patients Undergoing Major Non Cardiac Surgery

NCT ID: NCT02012946

Last Updated: 2013-12-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-12-31

Brief Summary

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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

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Conditions

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Cardiovascular Diseases

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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dobutamine

patient receiving dobutamine

Group Type ACTIVE_COMPARATOR

Dobutamine

Intervention Type DRUG

patient receiving dobutamine

Levosimendan

patient receiving levosimendan

Group Type ACTIVE_COMPARATOR

Levosimendan

Intervention Type DRUG

patient receiving levosimendan

Interventions

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Levosimendan

patient receiving levosimendan

Intervention Type DRUG

Dobutamine

patient receiving dobutamine

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Azienda Policlinico Umberto I

OTHER

Sponsor Role lead

Responsible Party

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francesco pugliese

professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Francesco Pugliese

Rome, Rome, Italy

Site Status

Countries

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Italy

Facility Contacts

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Role: primary

Other Identifiers

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levodobu

Identifier Type: -

Identifier Source: org_study_id