Clinical trial NCT01595737: Comparison of the Administration of Levosimendan and Placebo in the Preparation of Critical Patients for Heart Surgery
Official title: Comparison of the Administration of Levosimendan and Placebo in the Preparation of Critical Patients for Heart Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Cardiac Surgery
Lead sponsor: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Sponsor class: OTHER
First posted: 2012-05-10
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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%.


Eligibility 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.

Primary outcomes:
measure: Mortality
timeFrame: 30 days
measure: Morbidity
timeFrame: 30 days
Secondary outcomes:
measure: Dose of inotropic drugs used
timeFrame: 30 days
measure: Dose of vasoactive drugs used
timeFrame: 30 days
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Hospital de la Santa Creu i Sant Pau
Study officials:
References: