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

Not Applicable

• Conditions: Cardiac; Cardiovascular - Diseases of the vasculature and circulation including the lymphatic system

• Registration Number: ACTRN12609000899246
• Lead Sponsor: Intensive Care Research Fund

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2009-10-16
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 60

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To detect a 40 % increase in Cardiac Index on day 5 post cardiac surgery from baseline[Days 1 and 5]

Secondary Outcome Measures

Name	Time	Method
All cause mortality and 180 day mortality[measured from baseline through to 180 days]