Renal Effects of Levosimendan in Cardiac Surgery Patients

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01918618

Enrollment

Registered

2013-08-08

Start date

2013-04-30

Completion date

2013-06-30

Last updated

2013-08-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

levosimendan, renal effects, cardiac surgery, left heart insufficiency

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.

Interventions

None listed

Study design

Observational model

CASE_CONTROL

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Change of plasma creatinine (Difference in renal function)	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)	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)	last day of hospital stay	—

Secondary

Measure	Time frame
Cumulative Length of stay (hospital and ICU)	last day of hospital stay
In-hospital mortality	last day of hospital stay

Countries

Germany

Outcome results