Evaluation of the organic effect of levosimendan after surgery in patients with low output syndrom.

• Conditions: ow cardiac output syndrome; MedDRA version: 17.1Level: PTClassification code 10024899Term: Low cardiac output syndromeSystem Organ Class: 10007541 - Cardiac disorders; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2014-001461-27-ES
• Lead Sponsor: FIMABIS

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2014-10-16
• Last Update Posted: 23 February 2015

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Patients where inotropic support is considered appropiate because of a diagnosis of low cardiac output, cardiac index, which remains below 2 L/min/m2 with POP greater than 15 mmHg and / or less than 65% satVO2) syndrome.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 60
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

. History of adverse reaction to levosimendan.
? Pregnant
? Combined surgery (eg valve repair or carotid surgery).
? Patients in situations of hemodynamic instability.
? preoperative renal dysfunction, estimated by the rate of preoperative GFR (creatinine clearance <50ml/min).
? Hypersensitivity to levosimendan or any of the excipients.
? significant mechanical obstructions affecting ventricular filling or emptying, or both.
? History of Torsades de Pointes.
? Status of cardiogenic shock (lactate> 4 mmol / L)

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified