Effects of Levosimendan in Acute Kidney Injury After Cardiac Surgery

Acute Kidney Injury Clinical Trial

— LEVOAKI  

Official title:

Effects of Levosimendan in Acute Kidney Injury After Cardiac Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02531724
• Other study ID #: SahlgrenskaUHThoraxLL3
• Status: Completed
• Phase: Phase 4
• Start date: September 2015
• Est. completion date: December 2020

Study information

• Verified date: March 2021
• Source: Sahlgrenska University Hospital, Sweden
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Acute kidney injury (AKI) is a common complication after cardiac surgery. Mismatch in renal oxygen demand-supply may be an important pathogenetic factor. Levosimendan has been shown to improve renal blood flow, glomerular filtration rate and renal oxygenation in healthy controls after cardiac surgery.

In order to investigate the effect of levosimendan in patients with AKI after cardiac surgery, the investigators plan a randomized placebo controlled trial. 30 patients will receive levosimendan or placebo. Renal blood flow and filtration fraction will be measured using infusion clearance technique of para-aminohippuric acid and Chromium ethylenediaminetetraacetic acid (Cr-EDTA) respectively.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: December 2020
• Est. primary completion date: December 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients in the cardiothoracic intensive care after cardiac surgery with cardiopulmonary bypass

• Acute kidney injury, defined as increase in S-creatinine 50% or 27 mol/L

• Normal S-creatinine before surgery

Exclusion Criteria:

• Ongoing treatment with inotropic drugs (not norepinephrine)

• Central venous oxygen saturation (ScvO2) < 60% despite optimization of hematocrit and volume status

• Need of renal replacement therapy

• Ongoing bleeding

• Patient or next of kin does not consent with study participation

Related Conditions & MeSH terms

• Acute Kidney Injury
• Renal Insufficiency
• Renal Insufficiency, Acute
• Wounds and Injuries

Intervention

Drug:
• Levosimendan

• Placebo
Sodium chloride

Locations

Country	Name	City	State
Sweden	Department of thoracic anesthesia, Sahlgrenska University Hospital	Gothenburg

Sponsors (1)

Lead Sponsor	Collaborator
Sahlgrenska University Hospital, Sweden

Country where clinical trial is conducted

Sweden, 

References & Publications (1)

Bragadottir G, Redfors B, Ricksten SE. Effects of levosimendan on glomerular filtration rate, renal blood flow, and renal oxygenation after cardiac surgery with cardiopulmonary bypass: a randomized placebo-controlled study. Crit Care Med. 2013 Oct;41(10):2328-35. doi: 10.1097/CCM.0b013e31828e946a. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Renal blood flow	Renal blood flow will be measured using infusion clearance technique of para-aminohippuric acid. Measurements will be made in duplicates before and after administration of the study drug.	5 Hours
Primary	Glomerular filtration rate	Filtration fraction will be determined using be measured using infusion clearance technique of Chromium ethylenediaminetetraacetic acid (Cr-EDTA). Measurements will be made in duplicates before and after administration of the study drug. Glomerular filtration rate will be calculated as the filtration fraction multiplied by renal plasma flow.	5 Hours
Secondary	Serum creatinine	Measurement of serum creatinine will be made daily the first 4 days after the study	4 days