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CompletedNCT02275013Updated Oct 27, 2014

Levosimendan Administration and Outcome in Cardiac Surgery

An observational study in Treatment of Left Heart Insufficiency in an Operative Setting of Cardiac Surgery, sponsored by Charite University, Berlin, Germany. Completed at 1 site in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2014-10-27.

Sponsored by Charite University, Berlin, Germany · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
159
Ages
18 Years and older
Sex
All
01

Study summary

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.

02

Conditions studied

  • Treatment of Left Heart Insufficiency in an Operative Setting of Cardiac Surgery

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03

In context

Heart Failure

5,701 studies on the registry are indexed under Heart Failure; 1,220 are open to participants now.

This study's enrollment of 159 is below the median of 200 across 1,679 observational studies indexed under Heart Failure.

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Lead sponsor

Charite University, Berlin, Germany is the lead sponsor of 836 studies on the registry; 129 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Cardiac surgery patients

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • patients younger than 18
05

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
159 participants (actual)
Patient registry
No

Groups and cohorts

  • 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

Interventions

  • DrugLevosimendan
06

What researchers measure

Primary outcomes

  1. In-hospital mortality

    Time frame: until discharge, an average of 3 weeks length of stay

  2. 1 year follow-up mortality

    Time frame: 1 year after surgery

Secondary outcomes

  1. Duration of mechanical ventilation

    Time frame: until discharge, an average of 3 weeks length of stay

  2. Incidence of renal dysfunction

    Time frame: until discharge, an average of 3 weeks length of stay

  3. Incidence of renal replacement therapy

    Time frame: until discharge, an average of 3 weeks length of stay

07

Study locations

1 site
  • Charité University Medicine
    Berlin, 10117, Germany
08

References and documents

Publications

  • Treskatsch S, Balzer F, Geyer T, Spies CD, Kastrup M, Grubitzsch H, Wernecke KD, Erb JM, Braun JP, Sander M. Early levosimendan administration is associated with decreased mortality after cardiac surgery. J Crit Care. 2015 Aug;30(4):859.e1-6. doi: 10.1016/j.jcrc.2015.03.008. Epub 2015 Mar 13. PubMed 25837801 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 27, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02275013
Lead sponsor
Charite University, Berlin, Germany
Responsible party
Michael Sander (Univ-Prof. Dr. med., Charite University, Berlin, Germany) — Principal investigator
First posted
Oct 27, 2014
Start date
Jan 2006
Primary completion
Dec 2013
Completion
Dec 2013
Last update
Oct 27, 2014
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2014. You cannot join it, but the record below documents what was studied.

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