Treatment of Left Heart Insufficiency in an Operative Setting of Cardiac SurgeryNCT02275013
Levosimendan Administration and Outcome in Cardiac Surgery
An observational study of Treatment of Left Heart Insufficiency in an Operative Setting of Cardiac Surgery, run by Charite University, Berlin, Germany at 1 site in Germany.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Treatment of Left Heart Insufficiency in an Operative Setting of Cardiac Surgery
- What is being tested?
- Levosimendan
- How many people
- 159 participants
- Where
- 1 siteGermany
- Study dates
- Jan 2006to Dec 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Cardiac surgery patients
Who may be able to join
- patients undergoing cardiac surgery between 2006 and 2013
- levosimendan administration within 24 hours of postoperative ICU admission
Who cannot join
- patients younger than 18
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Being tested
- Levosimendan
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LevosimendanDrug
| Study group | Role | What they receive |
|---|---|---|
| Early | Levosimendan administration within first hour of post-operative ICU admission Receives: Drug: Levosimendan | |
| Late | Levosimendan administration within 24 hours of post-operative ICU admission but after first hour Receives: Drug: Levosimendan |
What is being measured
The primary outcome is the main question the study is designed to answer.
In-hospital mortality
Measured: until discharge, an average of 3 weeks length of stay
1 year follow-up mortality
Measured: 1 year after surgery
Secondary outcomes (3)
Duration of mechanical ventilation
Measured: until discharge, an average of 3 weeks length of stay
Incidence of renal dysfunction
Measured: until discharge, an average of 3 weeks length of stay
Incidence of renal replacement therapy
Measured: until discharge, an average of 3 weeks length of stay
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2014 (estimated)
- Study startJan 2006
- Primary completionDec 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Treatment of Left Heart Insufficiency in an Operative Setting of Cardiac SurgeryStudies of the same condition, open and under way.
- More trials run by Charite University, Berlin, GermanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 159 participants (actual)
Sponsor and investigators
- Lead sponsor
- Charite University, Berlin, Germany
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michael Sander, Charite University, Berlin, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02275013
- Sponsor's protocol ID
- ea1-044-13b
- Status last verified
- Oct 2014
- First submitted
- 23 Oct 2014
- Last updated
- 27 Oct 2014
- Results posted
- No
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
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Levosimendan Administration and Outcome in Cardiac Surgery
- ClinicalTrials.gov ID
- NCT02275013
- Acronym / sponsor ID
- ea1-044-13b
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 159 participants (actual)
- Lead sponsor
- Charite University, Berlin, GermanyUniversity, hospital or other
- Study start
- Jan 2006
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 27 Oct 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Early | – | Drug: LevosimendanLevosimendan administration within first hour of post-operative ICU admission |
| Late | – | Drug: LevosimendanLevosimendan administration within 24 hours of post-operative ICU admission but after first hour |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Cardiac surgery patients
Key inclusion criteria (2 listed)
- patients undergoing cardiac surgery between 2006 and 2013
- levosimendan administration within 24 hours of postoperative ICU admission
Key exclusion criteria (1 listed)
- patients younger than 18
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Levosimendan | Drug | Early, Late |
Primary outcome
In-hospital mortality
Time frame: until discharge, an average of 3 weeks length of stay
1 year follow-up mortality
Time frame: 1 year after surgery
3 secondary outcomes
Duration of mechanical ventilation
Time frame: 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
Incidence of renal replacement therapy
Time frame: until discharge, an average of 3 weeks length of stay
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2014.
- Derived from this study: PubMed 25837801Treskatsch 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Treatment of Left Heart Insufficiency in an Operative Setting of Cardiac Surgery, run by Charite University, Berlin, Germany at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Oct 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
In-hospital mortality (time frame: until discharge, an average of 3 weeks length of stay). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02275013, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2014.