Comparison between levosimendan and placebo in acute renal failure after cardiac surgery

Conditions: Acute kidney injury postoperatively in connection with heart surgery
Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

Registration Number: EUCTR2014-003589-25-SE

Lead Sponsor: Sahlgrenska Universitetssjukhuset/Sahlgrenska

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

-Patient to undergo a planned heart surgery with heart-lung machine
-Patient must have normal renal function preoperatively, s-creatinine <110 umol/L
-Age > 18 years
-Patient must have developed acute renal failure, defined as serum creatinine increase> 50% or 27 mmol / L
-Patient and/or family members must be in favor of participating in the investigation
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 25
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 5

Exclusion Criteria

-Ongoing treatment with inotropes such as milrinone, levosimendan, dopamine or dobutamine (norepinephrine does not count as inotropic drugs)
-Second central venous saturation <60% despite optimization of volume status and hematocrit
-Pregnant women in the first trimester due 51 Cr-EDTA (radiolabeled)
-Pregnant women due lack of documentation of levosimendan

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To investigate the effects of levosimendan vs. placebo on the kidney glomerular filtration rate (GFR).;Secondary Objective: Renal blood flow (RBF), renal vascular resistance (RVR), filtration fraction (GFR / RBF), diuresis, renal sodium excretion, cardiac output (CO), mean arterial pressure (MAP), heart rate, central venous pressure (CVP).;Primary end point(s): Change in GFR (mL/min) measured by infusion clearance of Cr-EDTA.;Timepoint(s) of evaluation of this end point: 70 minutes after infusion of levosimendan

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Renal blood flow (RBF), renal vascular resistance (RVR), filtration fraction (GFR / RBF), diuresis, renal sodium excretion, cardiac output (CO), mean arterial pressure (MAP), heart rate, central venous pressure (CVP).;Timepoint(s) of evaluation of this end point: 70 minutes after infusion of levosimendan