Renal Effects of Levosimendan in Cardiac Surgery Patients

NCT01918618 | Completed

• 1 other identifier: EA1-044-13
• Study Type: observational
• Target: 92
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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

Keywords

levosimendan; renal effects; cardiac surgery; left heart insufficiency

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• Cumulative incidence and duration of hemodialysis (Difference in renal function)

  last day of hospital stay

Secondary Outcomes (2)

• Cumulative Length of stay (hospital and ICU)

  last day of hospital stay

• In-hospital mortality

  last day of hospital stay

Study Arms (2)

Levosimendan

study group

No Levosimendan

Control group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

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

You may qualify if:

• 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

You may not qualify if:

• Patients younger 18
• Preexisting renal insufficiency

Sponsors & Collaborators

• Charite University, Berlin, Germany: lead

Study Sites (1)

Charité - University Medicine Berlin

Berlin, State of Berlin, 10117, Germany

Location

Related Publications (3)

• 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.

  PMID: 17331245 BACKGROUND

• 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. doi: 10.1510/icvts.2007.161356. Epub 2007 Dec 3.

  PMID: 18056154 BACKGROUND

• Balzer 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.

  PMID: 25399779 DERIVED

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PD Dr. med.

Study Record Dates

• First Submitted: July 26, 2013
• First Posted: August 8, 2013
• Study Start: April 1, 2013
• Primary Completion: April 1, 2013
• Study Completion: June 1, 2013
• Last Updated: August 8, 2013

Record last verified: 2013-08

Locations

DE (1)