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

• ClinicalTrials.gov Identifier: NCT01595737
• Recruitment Status: Completed
• First Posted: May 10, 2012
• Last Update Posted: March 12, 2015
• Sponsor: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
• Information provided by (Responsible Party): Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

Study Description

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%.

Condition or disease	Intervention/treatment	Phase
Cardiac Surgery	Drug: Levosimendan; Drug: Placebo	Phase 4

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 30 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Prevention
• Official Title: Comparison of the Administration of Levosimendan and Placebo in the Preparation of Critical Patients for Heart Surgery
• Study Start Date: February 2011
• Actual Primary Completion Date: November 2014
• Actual Study Completion Date: November 2014

Arms and Interventions

Arm	Intervention/treatment
Experimental: Levosimendan	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 Comparator: Placebo	Drug: 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.

Outcome Measures

Primary Outcome Measures :

1. Mortality [ Time Frame: 30 days ]
   Rate of mortality
2. Morbidity [ Time Frame: 30 days ]
   Rate of morbidity

Secondary Outcome Measures :

1. Dose of inotropic drugs used [ Time Frame: 30 days ]
   Requirements for inotropic drugs
2. Dose of vasoactive drugs used [ Time Frame: 30 days ]
   Requirements for vasoactive drugs

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 85 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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.

Contacts and Locations

Locations

Spain

Hospital de la Santa Creu i Sant Pau

Barcelona, Spain, 08025

Sponsors and Collaborators

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

More Information

• Responsible Party: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
• ClinicalTrials.gov Identifier: NCT01595737
• Other Study ID Numbers: ACA-SPAI-2008-20
• First Posted: May 10, 2012
• Last Update Posted: March 12, 2015
• Last Verified: May 2012

Additional relevant MeSH terms:

Simendan; Cardiotonic Agents; Vasodilator Agents; Phosphodiesterase 3 Inhibitors; Phosphodiesterase Inhibitors; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action; Protective Agents; Physiological Effects of Drugs