NCT02275013

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
159

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2006

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2006

Completed
7.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

October 23, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 27, 2014

Completed
Last Updated

October 27, 2014

Status Verified

October 1, 2014

Enrollment Period

7.9 years

First QC Date

October 23, 2014

Last Update Submit

October 23, 2014

Conditions

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

Outcome Measures

Primary Outcomes (2)

  • In-hospital mortality

    until discharge, an average of 3 weeks length of stay

  • 1 year follow-up mortality

    1 year after surgery

Secondary Outcomes (3)

  • Duration of mechanical ventilation

    until discharge, an average of 3 weeks length of stay

  • Incidence of renal dysfunction

    until discharge, an average of 3 weeks length of stay

  • Incidence of renal replacement therapy

    until discharge, an average of 3 weeks length of stay

Study Arms (2)

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

LevosimendanDRUG
EarlyLate

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Cardiac surgery patients

You may qualify if:

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

You may not qualify if:

  • patients younger than 18

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Charité University Medicine

Berlin, State of Berlin, 10117, Germany

Location

Related Publications (1)

  • 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.

    PMID: 25837801DERIVED

MeSH Terms

Interventions

Simendan

Intervention Hierarchy (Ancestors)

HydrazonesHydrazinesOrganic ChemicalsPyridazinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Univ-Prof. Dr. med.

Study Record Dates

First Submitted

October 23, 2014

First Posted

October 27, 2014

Study Start

January 1, 2006

Primary Completion

December 1, 2013

Study Completion

December 1, 2013

Last Updated

October 27, 2014

Record last verified: 2014-10

Locations

DE(1)