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

The effect of levosimendan, on renal blood flow, function and oxygen uptake during acute renal failure after cardiac surgery - Levo-AKI

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2014-003589-25-SE

Enrollment

Registered

2014-09-03

Start date

2014-11-11

Completion date

Unknown

Last updated

2025-01-07

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

Conditions

Acute kidney injury postoperatively in connection with heart surgery

Interventions

Trade Name: Simdax Product Name: Simdax Pharmaceutical Form: Concentrate and solvent for solution for infusion INN or Proposed INN: LEVOSIMENDAN CAS Number: 141505-33-1 Concentration unit: mg/kg/h mil

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: -Patient to undergo a planned heart surgery with heart-lung machine -Patient must have normal renal function preoperatively, s-creatinine 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

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

Design outcomes

Primary

Measure	Time frame
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	—

Measure

Time frame

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

Measure	Time frame
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	—

Countries

Sweden

Contacts

Public ContactTIVA

Sahlgrenska Universitetssjukhuset/Sahlgrenska

raija.saikkonen@vgregion.se46(0)31342 10 00 7798

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026