The Effects of Dobutamine and Levosimendan in High Risk Cardiac Surgery Patients

Status

Not yet recruiting

Phases

Unknown

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12609000899246

Enrollment

Registered

2009-10-16

Start date

2009-12-01

Completion date

Unknown

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Single centre double blinded randomised trial comparing Levosimendan with Dobutamine in high risk cardiac surgery patients.

Interventions

Patients will recieve intravenous Levosimendan 0.1-0.2 mcg/kg/min for 24hrs

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Blinded (masking used)

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Healthy volunteers

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.

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.

Outcome results