NCT02531724: LEVOAKI

Effects of Levosimendan in Acute Kidney Injury After Cardiac Surgery

Completed Phase 4 Last updated 17 March 2021

What this trial tests

Phase 4 trial testing Levosimendan in Acute Kidney Injury in 30 participants. Completed in 1 December 2020.

Timeline

1 September 2015

Primary endpoint
1 December 2020

1 December 2020

Quick facts

Lead sponsor	Sahlgrenska University Hospital
Phase	Phase 4
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	treatment
Enrollment	30
Start date	1 September 2015
Primary completion	1 December 2020
Estimated completion	1 December 2020
Sites	1 location across Sweden

Drugs / interventions tested

• Levosimendan (LEVOSIMENDAN) — full drug profile →
• Placebo

Conditions studied

• Acute Kidney Injury — all drugs for Acute Kidney Injury →
• Renal Insufficiency, Acute — all drugs for Renal Insufficiency, Acute →

Sponsor

Sahlgrenska University Hospital

Who can join

18 and older, any sex, with Acute Kidney Injury or Renal Insufficiency, Acute. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Renal blood flow
  Time frame: 5 Hours
  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.
• Glomerular filtration rate
  Time frame: 5 Hours
  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.

Sponsor's own description

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.

Publications & conference data

7 peer-reviewed publications reference this trial (live from Europe PMC):

1. Perioperative Acute Kidney Injury.
   Gumbert SD, Kork F, Jackson ML, Vanga N, et al · · 2020 · cited 209× · PMID 31687986 · DOI 10.1097/aln.0000000000002968
2. Levosimendan Efficacy and Safety: 20 Years of SIMDAX in Clinical Use.
   Papp Z, Agostoni P, Alvarez J, Bettex D, et al · · 2020 · cited 47× · PMID 32639325 · DOI 10.1097/fjc.0000000000000859
3. Levosimendan Efficacy and Safety: 20 years of SIMDAX in Clinical Use.
   Papp Z, Agostoni P, Alvarez J, Bettex D, et al · · 2020 · cited 41× · PMID 32714567 · DOI 10.15420/cfr.2020.03
4. New drugs for acute kidney injury.
   Pickkers P, Murray PT, Ostermann M. · · 2022 · cited 33× · PMID 35999470 · DOI 10.1007/s00134-022-06859-y
5. Acute kidney injury: emerging pharmacotherapies in current clinical trials.
   Benoit SW, Devarajan P. · · 2018 · cited 33× · PMID 28601936 · DOI 10.1007/s00467-017-3695-3
6. Effects of levosimendan on renal blood flow and glomerular filtration in patients with acute kidney injury after cardiac surgery: a double blind, randomized placebo-controlled study.
   Tholén M, Ricksten SE, Lannemyr L. · · 2021 · cited 25× · PMID 34118980 · DOI 10.1186/s13054-021-03628-z
7. New drugs for acute kidney injury.
   Hariri G, Legrand M. · · 2025 · cited 8× · PMID 39872831 · DOI 10.1016/j.jointm.2024.08.001