Levosimendan Administration and Outcome in Cardiac Surgery

October 23, 2014 updated by: Michael Sander, Charite University, Berlin, Germany
To assess the effects on outcome of levosimendan with respect to timing of its administration on the postoperative course of high-risk cardiac surgery patients in a retrospective observational study.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

159

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

  • Germany
      • Berlin, Germany, 10117
        • Charité University Medicine

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 and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Cardiac surgery patients

Description

Inclusion Criteria:

  • patients undergoing cardiac surgery between 2006 and 2013
  • levosimendan administration within 24 hours of postoperative ICU admission

Exclusion Criteria:

  • patients younger than 18

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Early
Levosimendan administration within first hour of post-operative ICU admission
Drug: Levosimendan
Late
Levosimendan administration within 24 hours of post-operative ICU admission but after first hour
Drug: Levosimendan

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
In-hospital mortality
Time Frame: until discharge, an average of 3 weeks length of stay
until discharge, an average of 3 weeks length of stay
1 year follow-up mortality
Time Frame: 1 year after surgery
1 year after surgery

Secondary Outcome Measures

Outcome Measure
Time Frame
Duration of mechanical ventilation
Time Frame: until discharge, an average of 3 weeks length of stay
until discharge, an average of 3 weeks length of stay
Incidence of renal dysfunction
Time Frame: until discharge, an average of 3 weeks length of stay
until discharge, an average of 3 weeks length of stay
Incidence of renal replacement therapy
Time Frame: until discharge, an average of 3 weeks length of stay
until discharge, an average of 3 weeks length of stay

Collaborators and Investigators

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

Sponsor

Charite University, Berlin, Germany

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

January 1, 2006

Primary Completion (Actual)

December 1, 2013

Study Completion (Actual)

December 1, 2013

Study Registration Dates

First Submitted

October 23, 2014

First Submitted That Met QC Criteria

October 23, 2014

First Posted (Estimate)

October 27, 2014

Study Record Updates

Last Update Posted (Estimate)

October 27, 2014

Last Update Submitted That Met QC Criteria

October 23, 2014

Last Verified

October 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ea1-044-13b

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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