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

Cardiac Surgery Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01595737
• Other study ID #: ACA-SPAI-2008-20
• Status: Completed
• Phase: Phase 4
• First received: May 7, 2012
• Last updated: March 11, 2015
• Start date: February 2011
• Est. completion date: November 2014

Study information

• Verified date: May 2012
• Source: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Spanish Agency of Medicines
• Study type: Interventional

Clinical Trial 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%.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: November 2014
• Est. primary completion date: November 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

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

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Cardiac Surgery

Intervention

Drug:
• Levosimendan
Levosimendan perfusion for 12 hours before surgery by a single route, at a dosage of 0.1µg/kg/min without receiving the loading dose.
• Placebo
Placebo group patients will receive a perfusion of 5% glucose solution. This clear solution, free of visible particles, will have 0.4mg of riboflavin sodium phosphate, 100mg of anhydrous alcohol and water for injection up to 1ml added to it. This solution will be calculated as a dose of 0.1µg/kg/min.

Locations

Country	Name	City	State
Spain	Hospital de la Santa Creu i Sant Pau	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mortality	Rate of mortality	30 days	No
Primary	Morbidity	Rate of morbidity	30 days	No
Secondary	Dose of inotropic drugs used	Requirements for inotropic drugs	30 days	No
Secondary	Dose of vasoactive drugs used	Requirements for vasoactive drugs	30 days	No