Renal Effects of Levosimendan in Cardiac Surgery Patients

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01918618
• Other study ID #: EA1-044-13
• Status: Completed
• Phase: N/A
• First received: July 26, 2013
• Last updated: August 6, 2013
• Start date: April 2013
• Est. completion date: June 2013

Study information

• Verified date: August 2013
• Source: Charite University, Berlin, Germany
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Observational

Clinical 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 92
• Est. completion date: June 2013
• Est. primary completion date: April 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• Patients younger 18

• Preexisting renal insufficiency

Study Design

Observational Model: Case Control, Time Perspective: Retrospective

Related Conditions & MeSH terms

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

Locations

Country	Name	City	State
Germany	Charité - University Medicine Berlin	Berlin

Sponsors (1)

Lead Sponsor	Collaborator
Charite University, Berlin, Germany

Country where clinical trial is conducted

Germany, 

References & Publications (2)

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. — View Citation

Yakut 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. Epub 2007 Dec 3. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change of plasma creatinine (Difference in renal function)	Only in patients not requiring renal replacement therapy	last available value pre-op (baseline), first available value on post-op day 1, 2, 3 and 4	Yes
Primary	Change of urine output after surgery (difference in renal function)	Only in patients not requiring renal replacement therapy	post-op day 1, 2, 3, 4	Yes
Primary	Cumulative incidence and duration of hemodialysis (Difference in renal function)		last day of hospital stay	Yes
Secondary	Cumulative Length of stay (hospital and ICU)		last day of hospital stay	Yes
Secondary	In-hospital mortality		last day of hospital stay	Yes