Comparison of Levosimendan and Dobutamine in cardiac surgery

Hemodynamic effects of Levosimendan in patient undergoing off–pump coronary artery bypass grafting and mitral valve replacement

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN54237076

Enrollment

Registered

2018-05-17

Start date

2017-08-01

Completion date

Unknown

Last updated

2019-04-29

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

Conditions

Heart failure Circulatory System Heart failure

Interventions

Participants are randomly allocated to group A (intervention) who receive Levosimendan (SIMDAX ®, country of origin Finland) 0.1mg/kg/min during the transanesthetic, postanesthetic and intensive thera

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Adult patients aged over 18 years 2. Left ventricular ejection fraction ==30%. 3. NYHA III-IV. 4. IC = 2.5L 5. ASA II or ASA III

Exclusion criteria

Exclusion criteria: None

Design outcomes

Primary

Measure	Time frame
1. Heart failure is recorded if CI <2.0 L/minm2 up to 48 hours postoperatively. 2. Low cardiac output defined 2 L/min/m2. Cardiac index is calculated from cardiac output, which is measured using the thermodilution technique via the Swan-Ganz catheter up to 48 hours postoperatively.	—

Secondary

Measure	Time frame
1. Central venous pressure, pulmonary capillary wedge pressure, systemic vascular resistance are measured with a pulmonary artery catheter. 2. Arterial blood pressure is measured via an arterial catheter. 3. Mixed venous oxygen saturation (SV02) is measured by analysis of blood gases. All the above outcomes are assessed on arrival back in the ICU following surgery (T1) and 48 hours postoperatively (T2).	—

Measure

Time frame

1. Central venous pressure, pulmonary capillary wedge pressure, systemic vascular resistance are measured with a pulmonary artery catheter. 2. Arterial blood pressure is measured via an arterial catheter. 3. Mixed venous oxygen saturation (SV02) is measured by analysis of blood gases. All the above outcomes are assessed on arrival back in the ICU following surgery (T1) and 48 hours postoperatively (T2).

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Countries

Mexico

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026