Comparison of the Administration of Levosimendan and Placebo in the Preparation of Critical Patients for Heart Surgery

Phase 4

Completed

• Conditions: Cardiac Surgery
• Interventions: Drug: Levosimendan; Drug: Placebo

• Registration Number: NCT01595737
• Lead Sponsor: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

Brief Summary

This study aims to examine the efficacy of levosimendan in terms of reducing postoperative mortality and severe morbidity in patients undergoing non-emergent surgery for coronary revascularisation with or without ischaemic mitral regurgitation and who may or may not require repair or replacement of the mitral valve and have a LVEF \< 35%.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-02
• Status Verified: 2012-05
• Study First Submitted: 2012-05-07
• Study First Submitted QC: 2012-05-08
• Study First Posted: 2012-05-10
• Primary Completion: 2014-11
• Study Completion: 2014-11
• Last Update Submitted: 2015-03-11
• Last Update Posted: 2015-03-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• Male or female > 18 years and < 85 years.
• LVEF ≤ 35%
• Indication for elective surgery for coronary revascularisation, with or without mitral valve repair.
• Freely choose to participate in trial and sign an informed consent

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Exclusion Criteria

• The patient does not accept the protocol.
• Allergy (hypersensitivity) to levosimendan, any of its components or to riboflavin.
• Severe hypotension or severe tachycardia prior to entering study.
• Significant mechanical obstruction affecting ventricular filling and/or emptying.
• History of Torsades.
• Requirement for inotropic or vasoactive drugs or any type of mechanical assistance for 48 hours prior to surgery.
• Onset of angina or acute myocardial infarction within 48 hours prior to surgery, or cardiogenic shock.
• Surgery needs that are different from those planned.
• Chronic or severe kidney failure requiring haemodialysis or peritoneal dialysis or creatinine clearance values below 30ml/min or presence of nephrotic syndrome.
• Liver failure with transaminases 4 times above the normal maximum value.
• The patient must undergo a concurrently scheduled surgery, such as for a valve other than the mitral.
• When a screening cannot be performed at least during the 24 hours before surgery.
• Uncontrolled diabetes mellitus (blood glucose > 24mmol/l or 432mg/dl).
• History of any disease over the last five years that may compromise the patient's life, other than their heart disease.
• The patient is currently abusing alcohol or toxic substances.
• Presence of any other medical or psychiatric condition that the researcher believes makes a candidate ineligible for the study.
• Women with childbearing potential who are not using an effective contraception method.
• Participation in the last 30 days in any other study with either experimental drugs or devices.
• Body Mass Index (BMI) greater than 35.
• Administration of levosimendan in the last 30 days.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Levosimendan	Levosimendan	-
Placebo	Placebo	-

Primary Outcome Measures

Name	Time	Method
Mortality	30 days	Rate of mortality
Morbidity	30 days	Rate of morbidity

Secondary Outcome Measures

Name	Time	Method
Dose of inotropic drugs used	30 days	Requirements for inotropic drugs
Dose of vasoactive drugs used	30 days	Requirements for vasoactive drugs

Trial Locations

Locations (1)

Hospital de la Santa Creu i Sant Pau; 🇪🇸 Barcelona, Spain