Treatment of Left Heart Insufficiency in an Operative Setting of Cardiac SurgeryNCT01918618
Renal Effects of Levosimendan in Cardiac Surgery Patients
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
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. 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
- How many people
- 92 participants
- Where
- 1 siteGermany
- Study dates
- Apr 2013to Jun 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: Patients undergoing cardiac surgery between 2007 and 2011 followed by postoperative observation on an ICU of the anaesthesiology department of the Charité hospital
Who may be able to join
- 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
Who cannot join
- Patients younger 18
- Preexisting renal insufficiency
Trial locations and contacts
1 site in 1 country.
Germany1 site
Charité - University Medicine Berlin
Berlin, State of Berlin, 10117
About this study
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.
- Keywords
- levosimendan, renal effects, cardiac surgery, left heart insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Levosimendan | study group | |
| No Levosimendan | Control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of plasma creatinine (Difference in renal function)
Only in patients not requiring renal replacement therapy
Measured: 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)
Only in patients not requiring renal replacement therapy
Measured: post-op day 1, 2, 3, 4
Cumulative incidence and duration of hemodialysis (Difference in renal function)
Measured: last day of hospital stay
Secondary outcomes (2)
Cumulative Length of stay (hospital and ICU)
Measured: last day of hospital stay
In-hospital mortality
Measured: last day of hospital stay
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2013 (estimated)
- Study startApr 2013
- Primary completionApr 2013
- Study completionJun 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)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
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 92 participants (actual)
Sponsor and investigators
- Lead sponsor
- Charite University, Berlin, Germany
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jan Braun, MD, Charite University, Berlin, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01918618
- Sponsor's protocol ID
- EA1-044-13
- Status last verified
- Aug 2013
- First submitted
- 26 Jul 2013
- Last updated
- 8 Aug 2013
- Results posted
- No
Publications
Mehta RL, Kellum JA, Shah SV, Molitoris BA, Ronco C, Warnock DG, Levin A; Acute Kidney Injury Network. Acute Kidney Injury Network: report of an initiative to improve outcomes in acute kidney injury. Crit Care. 2007;11(2):R31. doi: 10.1186/cc5713.
PubMed 17331245Yakut N, Yasa H, Bahriye Lafci B, Ortac R, Tulukoglu E, Aksun M, Ozbek C, Gurbuz A. The influence of levosimendan and iloprost on renal ischemia-reperfusion: an experimental study. Interact Cardiovasc Thorac Surg. 2008 Apr;7(2):235-9. doi: 10.1510/icvts.2007.161356. Epub 2007 Dec 3.
PubMed 18056154Balzer F, Treskatsch S, Spies C, Sander M, Kastrup M, Grubitzsch H, Wernecke KD, Braun JP. Early administration of levosimendan is associated with improved kidney function after cardiac surgery - a retrospective analysis. J Cardiothorac Surg. 2014 Nov 18;9:167. doi: 10.1186/s13019-014-0167-8.
PubMed 25399779
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Renal Effects of Levosimendan in Cardiac Surgery Patients
- ClinicalTrials.gov ID
- NCT01918618
- Acronym / sponsor ID
- EA1-044-13
- Keywords
- levosimendan, renal effects, cardiac surgery, left heart insufficiency
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 92 participants (actual)
- Lead sponsor
- Charite University, Berlin, GermanyUniversity, hospital or other
- Study start
- Apr 2013
- Primary completion
- Apr 2013 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 8 Aug 2013 (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.
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 design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Levosimendan | – | –study group |
| No Levosimendan | – | –Control group |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (2 listed)
- Patients younger 18
- Preexisting renal insufficiency
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
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
Cumulative incidence and duration of hemodialysis (Difference in renal function)
Time frame: last day of hospital stay
2 secondary outcomes
Cumulative Length of stay (hospital and ICU)
Time frame: last day of hospital stay
In-hospital mortality
Time frame: last day of hospital 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 8 Aug 2013.
- Background: PubMed 17331245Mehta RL, Kellum JA, Shah SV, Molitoris BA, Ronco C, Warnock DG, Levin A; Acute Kidney Injury Network. Acute Kidney Injury Network: report of an initiative to improve outcomes in acute kidney injury. Crit Care. 2007;11(2):R31. doi: 10.1186/cc5713.
- Background: PubMed 18056154Yakut N, Yasa H, Bahriye Lafci B, Ortac R, Tulukoglu E, Aksun M, Ozbek C, Gurbuz A. The influence of levosimendan and iloprost on renal ischemia-reperfusion: an experimental study. Interact Cardiovasc Thorac Surg. 2008 Apr;7(2):235-9. doi: 10.1510/icvts.2007.161356. Epub 2007 Dec 3.
- Derived from this study: PubMed 25399779Balzer F, Treskatsch S, Spies C, Sander M, Kastrup M, Grubitzsch H, Wernecke KD, Braun JP. Early administration of levosimendan is associated with improved kidney function after cardiac surgery - a retrospective analysis. J Cardiothorac Surg. 2014 Nov 18;9:167. doi: 10.1186/s13019-014-0167-8.
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 1 inclusion and 2 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 8 Aug 2013. 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?
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). The study lists 3 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 NCT01918618, which also lists 3 linked publications.
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 8 Aug 2013.