Condition category
Circulatory System
Date applied
04/02/2008
Date assigned
11/04/2008
Last edited
20/05/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Claudia Spies

ORCID ID

Contact details

Charitéplatz 1
Berlin
10117
Germany
claudia.spies@charite.de

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Acronym

LEVOHLM

Study hypothesis

The goal of the study is to confirm the improvement of the Sepsis-related Organ Failure Assessment Scores (SOFA Score) with infusion of levosimendan compared with placebo in high risk patients undergoing coronary artery bypass graft-operations.

The following hypothesis will be tested:
H0 (null hypothesis): SOFA (levosimendan) equal to SOFA (placebo)
HA (alternative hypothesis - two-sided): SOFA (levosimendan) not equal to SOFA (placebo)

As of 08/05/2009 this record was updated to include amended participant criteria - for full details go to the relevant fields. At this time, the anticipated end date of this trial was also extended; the initial anticipated end date at the time of registration was 01/02/2010.

Ethics approval

Ethics Committee of Berlin (Landesamt für Gesundheit und Soziales Geschäftsstelle der Ethik-Kommission des Landes Berlin), 28/12/2007.

Study design

Prospective randomised placebo-controlled double-blinded two-arm single-centre trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Coronary artery disease/coronary artery bypass graft operations

Intervention

Levosimendan (Simdax®) group: continuous application of levosimendan at 0.1 µg/kg body weight/min (concentration of the applied solution: 250 µg/ml levosimendan, 5% glucose), cumulative dose: 72 µg/kg body weight
Placebo group: 5% glucose and Soluvit® (multivitamin solution for colouring the medication)

Intervention type

Drug

Phase

Not Applicable

Drug names

Levosimendan

Primary outcome measures

The Sepsis-related Organ Failure Assessment (SOFA) score to describe organ dysfunction/failure. The SOFA score will be measured daily during the patient's stay in the Intensive Care Unit (ICU).

Secondary outcome measures

1. Haemodynamic values throughout surgery and during patient's stay in the ICU
2. Doses and duration of therapy with catecholamines
3. Echocardiographic parameter during surgery
4. Delta-creatinine clearance before and after surgery
5. Horowitz (oxygenation) index, measured every 12 hours during patient's stay in the ICU
6. Serum lactate values during surgery and patient's stay in the ICU
7. Survival after 30 days and after 6 months
8. Incidence and frequencies of haemodialysis during patient's stay in the ICU
9. Incidence and frequencies of hemodialysis after fulfilling ICU discharge criteria up to hospital discharge
10. Quality of life 6 months after surgery

Overall trial start date

05/02/2008

Overall trial end date

31/03/2012

Reason abandoned

Eligibility

Participant inclusion criteria

Amended as of 08/05/2009:
Point seven below is no longer an inclusion criteria and should be disregarded.

Initial information at time of registration:
1. Offered patient information and obtained informed consent
2. Aged over 18 years old
3. Negative pregnancy test or anamnestically more than two years post-menopausal
4. No participation in another drug study according to the pharmaceutical law
5. Patients undergoing elective coronary artery bypass graft-surgery because of ischaemic cardiomyopathy with or without heart valve repair
6. Left ventricular ejection fraction less than or equal to 30%
7. Compensated renal insufficiency (creatinine greater than 1.14 mg/dl)

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

100

Participant exclusion criteria

Amended as of 08/05/2009:
The following point has been amended:
10. Therapy with oral antidiabetics discontinued at least 36 hours before surgery

Initial information at time of registration:
1. Age under 18 years old
2. Pregnancy or lactation
3. Lacking willingness to save and hand out pseudonymised data within the study
4. A patient is admittted to an institution because of an official or medical order (according to German Medicines Act [AMG] Sectoin 40 (1) 4)
5. Liver disease (Child B or C cirrhosis, acute disease, End-Stage Liver Disease [MELD] score greater than 17)
6. Recent oesophageal or upper airway surgery
7. Severe oesophageal disease
8. Severe disease of the upper airways
9. Neurological/psychiatric disease
10. Therapy with oral antidiabetics
11. Infection with human immunodeficiency virus (HIV)
12. Active hepatitis B or C
13. Unclear history of alcohol related disorder

Recruitment start date

05/02/2008

Recruitment end date

31/03/2012

Locations

Countries of recruitment

Germany

Trial participating centre

Charitéplatz 1
Berlin
10117
Germany

Sponsor information

Organisation

Charité - University Medicine Berlin (Charité - Universitätsmedizin Berlin) (Germany)

Sponsor details

Charitéplatz 1
Berlin
10117
Germany
anaesth@charite.de

Sponsor type

University/education

Website

http://www.charite.de/

Funders

Funder type

University/education

Funder name

Charité - University Medicine Berlin (Charité - Universitätsmedizin Berlin) (Germany)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2014 results in: http://www.ncbi.nlm.nih.gov/pubmed/24781725

Publication citations

  1. Results

    Erb J, Beutlhauser T, Feldheiser A, Schuster B, Treskatsch S, Grubitzsch H, Spies C, Influence of levosimendan on organ dysfunction in patients with severely reduced left ventricular function undergoing cardiac surgery., J. Int. Med. Res., 2014, 42, 3, 750-764, doi: 10.1177/0300060513516293.

Additional files

Editorial Notes