Levosimendan Versus Dobutamine in Cardiopatic Patients Undergoing Major Non Cardiac Surgery

December 11, 2013 updated by: francesco pugliese, Azienda Policlinico Umberto I
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 Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Rome, Italy, 00100
        • Francesco Pugliese

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: dobutamine
patient receiving dobutamine
Drug: Dobutamine
patient receiving dobutamine
Active Comparator: Levosimendan
patient receiving levosimendan
Drug: Levosimendan
patient receiving levosimendan

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
cardiac index
Time Frame: 1-3 days
1-3 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Azienda Policlinico Umberto I

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2013

Primary Completion (Actual)

December 1, 2013

Study Registration Dates

First Submitted

December 11, 2013

First Submitted That Met QC Criteria

December 11, 2013

First Posted (Estimate)

December 17, 2013

Study Record Updates

Last Update Posted (Estimate)

December 17, 2013

Last Update Submitted That Met QC Criteria

December 11, 2013

Last Verified

December 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • levodobu

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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