NCT02531724

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Sep 2015

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 20, 2015

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 24, 2015

Completed
8 days until next milestone

Study Start

First participant enrolled

September 1, 2015

Completed
5.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2020

Completed
Last Updated

March 18, 2021

Status Verified

March 1, 2021

Enrollment Period

5.3 years

First QC Date

August 20, 2015

Last Update Submit

March 17, 2021

Conditions

Acute Kidney InjuryRenal Insufficiency, Acute

Keywords

acute kidney injurycardiac surgeryrenal blood flowlevosimendan

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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 Outcomes (1)

  • Serum creatinine

    4 days

Study Arms (2)

Levosimendan

ACTIVE COMPARATOR

Levosimendan will be given as a loading dose of 12 ug/kg during 30 minutes, and then a continuous infusion of 0,1 ug/kg/min for 180 minutes.

Drug: Levosimendan

Placebo

PLACEBO COMPARATOR

Sodium chloride will be given as a loading dose during 30 minutes and then a continuous infusion for 180 minutes at a rate mimicking the levosimendan group above.

Drug: Placebo

Interventions

LevosimendanDRUG
Also known as: Simdax
Levosimendan
PlaceboDRUG

Sodium chloride

Placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of thoracic anesthesia, Sahlgrenska University Hospital

Gothenburg, 41345, Sweden

Location

Related Publications (2)

  • 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.

    PMID: 23921271BACKGROUND

  • Tholen M, Ricksten SE, Lannemyr L. 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. Crit Care. 2021 Jun 12;25(1):207. doi: 10.1186/s13054-021-03628-z.

    PMID: 34118980DERIVED

MeSH Terms

Conditions

Acute Kidney Injury

Interventions

Simendan

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

HydrazonesHydrazinesOrganic ChemicalsPyridazinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Sven-Erik Ricksten, Professor

    Sahlgrenska Academy, dept of clinical science

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

August 20, 2015

First Posted

August 24, 2015

Study Start

September 1, 2015

Primary Completion

December 1, 2020

Study Completion

December 1, 2020

Last Updated

March 18, 2021

Record last verified: 2021-03

Locations

SE(1)