Levosimendan Administration and Outcome in Cardiac Surgery

Treatment of Left Heart Insufficiency in an Operative Setting of Cardiac Surgery Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02275013
• Other study ID #: ea1-044-13b
• Status: Completed
• Phase: N/A
• First received: October 23, 2014
• Last updated: October 23, 2014
• Start date: January 2006
• Est. completion date: December 2013

Study information

• Verified date: October 2014
• Source: Charite University, Berlin, Germany
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 159
• Est. completion date: December 2013
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

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

Intervention

Drug:
• Levosimendan

Locations

Country	Name	City	State
Germany	Charité University Medicine	Berlin

Sponsors (1)

Lead Sponsor	Collaborator
Charite University, Berlin, Germany

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	In-hospital mortality		until discharge, an average of 3 weeks length of stay	Yes
Primary	1 year follow-up mortality		1 year after surgery	Yes
Secondary	Duration of mechanical ventilation		until discharge, an average of 3 weeks length of stay	Yes
Secondary	Incidence of renal dysfunction		until discharge, an average of 3 weeks length of stay	Yes
Secondary	Incidence of renal replacement therapy		until discharge, an average of 3 weeks length of stay	Yes