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Clinical Trials/NCT02012946
NCT02012946UnknownPhase 4

Levosimendan Versus Dobutamine in Cardiopatic Patients Undergoing Major Non Cardiac Surgery

Azienda Policlinico Umberto I1 site in 1 country40 target enrollmentStarted: December 2013Last updated:
Conditions
Interventions
Drugs

Trial Snapshot

Phase
Phase 4
Enrollment
40
Locations
1
Primary Endpoint
cardiac index

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Supportive Care
Masking
None

Eligibility Criteria

Ages
18 Years to 85 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Arms & Interventions

dobutamine

Active Comparator

patient receiving dobutamine

Intervention: Dobutamine (Drug)

Levosimendan

Active Comparator

patient receiving levosimendan

Intervention: Levosimendan (Drug)

Outcomes

Primary Outcomes

cardiac index

Time Frame: 1-3 days

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

francesco pugliese

professor

Azienda Policlinico Umberto I

Study Sites (1)

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