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Effects of Levosimendan in Acute Kidney Injury After Cardiac Surgery (LEVOAKI)

Primary Purpose

Acute Kidney Injury, Renal Insufficiency, Acute

Status
Completed
Phase
Phase 4
Locations
Sweden
Study Type
Interventional
Intervention
Levosimendan
Placebo
Sponsored by
Sahlgrenska University Hospital, Sweden
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Kidney Injury focused on measuring acute kidney injury, cardiac surgery, renal blood flow, levosimendan

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Department of thoracic anesthesia, Sahlgrenska University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Levosimendan

Placebo

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

Serum creatinine
Measurement of serum creatinine will be made daily the first 4 days after the study

Full Information

First Posted
August 20, 2015
Last Updated
March 17, 2021
Sponsor
Sahlgrenska University Hospital, Sweden
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1. Study Identification

Unique Protocol Identification Number
NCT02531724
Brief Title
Effects of Levosimendan in Acute Kidney Injury After Cardiac Surgery
Acronym
LEVOAKI
Official Title
Effects of Levosimendan in Acute Kidney Injury After Cardiac Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
March 2021
Overall Recruitment Status
Completed
Study Start Date
September 2015 (Actual)
Primary Completion Date
December 2020 (Actual)
Study Completion Date
December 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sahlgrenska University Hospital, Sweden

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Kidney Injury, Renal Insufficiency, Acute
Keywords
acute kidney injury, cardiac surgery, renal blood flow, levosimendan

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Levosimendan
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Levosimendan
Other Intervention Name(s)
Simdax
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Sodium chloride
Primary Outcome Measure Information:
Title
Renal blood flow
Description
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.
Time Frame
5 Hours
Title
Glomerular filtration rate
Description
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.
Time Frame
5 Hours
Secondary Outcome Measure Information:
Title
Serum creatinine
Description
Measurement of serum creatinine will be made daily the first 4 days after the study
Time Frame
4 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sven-Erik Ricksten, Professor
Organizational Affiliation
Sahlgrenska Academy, dept of clinical science
Official's Role
Study Director
Facility Information:
Facility Name
Department of thoracic anesthesia, Sahlgrenska University Hospital
City
Gothenburg
ZIP/Postal Code
41345
Country
Sweden

12. IPD Sharing Statement

Citations:
PubMed Identifier
23921271
Citation
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.
Results Reference
background
PubMed Identifier
34118980
Citation
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.
Results Reference
derived

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Effects of Levosimendan in Acute Kidney Injury After Cardiac Surgery

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