Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12609000899246
Ethics application status
Approved
Date submitted
15/10/2009
Date registered
16/10/2009
Date last updated
9/07/2012
Type of registration
Prospectively registered

Titles & IDs
Public title
The Effects of Dobutamine and Levosimendan in High Risk Cardiac Surgery Patients
Scientific title
The Effects of Dobutamine and Levosimendan in High Risk Cardiac Surgery Patients
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cardiac 252010 0
Condition category
Condition code
Cardiovascular 252202 252202 0 0
Diseases of the vasculature and circulation including the lymphatic system

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Patients will recieve intravenous Levosimendan 0.1-0.2 mcg/kg/min for 24hrs
Intervention code [1] 241416 0
Treatment: Drugs
Comparator / control treatment
Dobutamine 2.5mcg/kg/min for 24hrs
Control group
Active

Outcomes
Primary outcome [1] 253078 0
To detect a 40 % increase in Cardiac Index on day 5 post cardiac surgery from baseline
Timepoint [1] 253078 0
Days 1 and 5
Secondary outcome [1] 257924 0
All cause mortality and 180 day mortality
Timepoint [1] 257924 0
measured from baseline through to 180 days

Eligibility
Key inclusion criteria
Patients presenting for Coronary artery bypass grafting or valve surgery or both.Documented pre operative left ventricular ejection fraction = 30 % or moderate to severe Left Ventricular Failure (echo finding).Willingness to give written informed consent and willingness to participate and comply with the study.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients who have received Levosimendan in the past 2 weeks.Patients who are moribund and not expected to survive. Patients with a history of a psychological illness or condition such as to interfere with the patient's ability to understand the requirements of the study.Patients with established renal failure ( Glomerular Filtration Rate <30 % +/- dialysis ).Patients who weigh >150 kg.Patients aged <18 years.Patients undergoing salvage surgery.Patients with a known or suspected infection and who also have 2 or more systemic inflammatory response syndrome criteria who are on high dose vasopressors (High dose vasopressors Noradrenaline >0.2 mcg/kg/min or Dobutamine >10 mcg/kg/min).Patients with cardiogenic shock due to an untreated mechanical cause ie pulmonary embolism, tamponade, acute valve disease . Patients with a known or suspected allergy to the study drugs.Cardiogenic shock unresponsive to high dose vasopressors (Noradrenaline >0.2 mcg/kg/min or Dobutamine >10 mcg/kg/min) persistant mean arterial pressure< 60 mmHG or systolic blood pressure < 80 mmHg.Congenital Heart disease or acquired structural cardiac defect eg ventricular septal defect. Administration of Milronone within 24 hours before the start of Levosimendan infusion.Women lactating, pregnant or of childbearing potential who are not willing to avoid becoming pregnant during the study.
History of Torsades de pointes.Uncorrected serum potassium levels <3.5mmols/L or >4.5mmols/L.Patients who appear to be responding adequately to standard therapy
.Severe obstruction of ventricular outflow tracts such as haemodynamically significant uncorrected primary valve disease and restricted or hypertrophic cardiomyopathy.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Randomised sealed envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Random computer generation in blocks
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/12/2009
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 243887 0
Hospital
Name [1] 243887 0
Intensive Care Research Fund
Country [1] 243887 0
Australia
Primary sponsor type
Hospital
Name
Intensive Care Research Fund
Address
Prince of Wales Hospital, Barker Street, Randwick, 2031 NSW
Country
Australia
Secondary sponsor category [1] 251228 0
None
Name [1] 251228 0
Address [1] 251228 0
Country [1] 251228 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 243999 0
Prince of Wales Hospital Ethics
Ethics committee address [1] 243999 0
Prince of Wales Hospital, Edmund Blacket Building, Avoca Street, Randwick, 2031, NSW
Ethics committee country [1] 243999 0
Australia
Date submitted for ethics approval [1] 243999 0
23/01/2009
Approval date [1] 243999 0
09/09/2009
Ethics approval number [1] 243999 0

Summary
Brief summary
Single centre double blinded randomised trial comparing Levosimendan with Dobutamine in high risk cardiac surgery patients.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 30325 0
Address 30325 0
Country 30325 0
Phone 30325 0
Fax 30325 0
Email 30325 0
Contact person for public queries
Name 13572 0
Dr Yahya Shehabi
Address 13572 0
Prince of Wales Hospital
Adult Intensive Care Unit
Barker Street
Randwick 2031 NSW
Country 13572 0
Australia
Phone 13572 0
+612 93824720
Fax 13572 0
+612 93824748
Email 13572 0
Yahya.Shehabi@sesiahs.health.nsw.gov.au
Contact person for scientific queries
Name 4500 0
Dr Yahya Shehabi
Address 4500 0
Prince of Wales Hospital
Adult Intensive Care Unit
Barker Street
Randwick 2031 NSW
Country 4500 0
Australia
Phone 4500 0
+612 93824720
Fax 4500 0
+612 93824748
Email 4500 0
Yahya.Shehabi@sesiahs.health.nsw.gov.au

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.