Renal Effects of Levosimendan in Cardiac Surgery Patients

August 6, 2013 updated by: Jan Braun, MD, Charite University, Berlin, Germany
Recent experimental and clinical data suggest a benefit of levosimendan on the kidney function. Therefore, this retrospective, single center, matched-pairs analysis aimed to investigate whether administration of levosimendan was associated with improved renal function in cardiac surgery patients.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

92

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 Berlin

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

Probability Sample

Study Population

Patients undergoing cardiac surgery between 2007 and 2011 followed by postoperative observation on an ICU of the anaesthesiology department of the Charité hospital

Description

Inclusion Criteria:

  • Patients undergoing cardiac surgery (OPS 5-35 bis 5-37) between 2007 and 2011 followed by postoperative observation on an ICU of the anaesthesiology department of the Charité hospital

Exclusion Criteria:

  • Patients younger 18
  • Preexisting renal insufficiency

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
Levosimendan
study group
No Levosimendan
Control group

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change of plasma creatinine (Difference in renal function)
Time Frame: last available value pre-op (baseline), first available value on post-op day 1, 2, 3 and 4
Only in patients not requiring renal replacement therapy
last available value pre-op (baseline), first available value on post-op day 1, 2, 3 and 4
Change of urine output after surgery (difference in renal function)
Time Frame: post-op day 1, 2, 3, 4
Only in patients not requiring renal replacement therapy
post-op day 1, 2, 3, 4
Cumulative incidence and duration of hemodialysis (Difference in renal function)
Time Frame: last day of hospital stay
last day of hospital stay

Secondary Outcome Measures

Outcome Measure
Time Frame
Cumulative Length of stay (hospital and ICU)
Time Frame: last day of hospital stay
last day of hospital stay
In-hospital mortality
Time Frame: last day of hospital stay
last day of hospital 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

April 1, 2013

Primary Completion (Actual)

April 1, 2013

Study Completion (Actual)

June 1, 2013

Study Registration Dates

First Submitted

July 26, 2013

First Submitted That Met QC Criteria

August 6, 2013

First Posted (Estimate)

August 8, 2013

Study Record Updates

Last Update Posted (Estimate)

August 8, 2013

Last Update Submitted That Met QC Criteria

August 6, 2013

Last Verified

August 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EA1-044-13

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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