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

Evaluation of the effect of organic preservation with the use of levosimendan after cardiac surgery in patients with low output syndrom compared with dobutamine. - FIM-BGC-2014-01

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2014-001461-27-ES
Enrollment
Unknown
Registered
2014-10-16
Start date
2015-01-19
Completion date
Unknown
Last updated
2015-02-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Low cardiac output syndrome MedDRA version: 17.1 Level: PT Classification code 10024899 Term: Low cardiac output syndrome System Organ Class: 10007541 - Cardiac disorders

Interventions

Trade Name: LEVOSIMENDAN Product Name: LEVOSIMENDAN Pharmaceutical Form: Concentrate and solvent for solution for infusion INN or Proposed INN: LEVOSIMENDAN CAS Number: 141505-33-1 Concentration unit:

Sponsors

FIMABIS
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

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 4 mmol / L)

Design outcomes

Primary

MeasureTime frame
Main Objective: To assess the effects of postoperative administration of levosimendan in patients with low output syndrome after cardiac surgery, renal and neurological level, measured by prognostic marker N-GAL and S 100 protein, compared with the rest of inotropic therapies and the initial situation of the patient.;Secondary Objective: To assess the effects on the various hemodynamic parameters (cardiac index and mixed venous saturation), biochemical marker of cardiac dysfunction (Nt-proBNP) and cardioprotective (troponin T) and the use of vasoactive drugs. ? Evaluate the relationship between therapy and renal function parameters. ? Assess whether there are differences in the incidence of arrhythmias in each of the groups.;Primary end point(s): To assess the effects of postoperative administration of levosimendan in patients with low output syndrome after cardiac surgery, renal and neurological level, measured by prognostic marker N-GAL and S 100 protein, compared with the rest of inotropic therapies and the initial situation of the patient.;Timepoint(s) of evaluation of this end point: Monthly—

Secondary

MeasureTime frame
Secondary end point(s): To assess the effects on the various hemodynamic parameters (cardiac index and mixed venous saturation), biochemical marker of cardiac dysfunction (Nt-proBNP) and cardioprotective (troponin T) and the use of vasoactive drugs. ? Evaluate the relationship between therapy and renal function parameters. ? Assess whether there are differences in the incidence of arrhythmias in each of the groups.;Timepoint(s) of evaluation of this end point: Monthly—

Countries

Spain

Contacts

Public ContactClinical Trials Unit

FIMABIS

gloria.luque.exts@juntadeandalucia.es34951291977

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026