high risk cardiac surgery affected by low cardiac output syndrome (LCOs) MedDRA version: 9.1 Level: SOC Classification code 10007541
Conditions
Interventions
Trade Name: SIMDAX
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: Levosimendan
Concentration unit: ml millilitre(s)
Concentration type: equal
Concentration number: 5-
Pharmaceutical f
Sponsors
FONDAZIONE CENTRO S. RAFFAELE DEL MONTE TABOR
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: -conseso informato scritto -eta` superiore ai 18 anni -disfunzione miocardica perioperatoria definita sindrome da bassa gittata etc. 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 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: trapianto del rene o del fegato; - previous unusual response to levosimendan or soluvit or any of their components - inclusion in other randomised controlled studies in the previous 30 days - levosimendan administration in the previous 30 days - Parkinson?s desease - emergency operation - Kidney or liver transplant - Liver cirrhosis (Child B or C) - decision to use ECMO (ECMO already started or planned) - do not resuscitate patient
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The study is powered to detect a reduction of the 30 days mortality in critically ill cardiac surgery patients from 10% to 5%.;Secondary Objective: (Secondary endpoints will be represented by --mortality at 1 year --time on mechanical ventilation --acute renal failure (following the R.I.F.L.E. score definition) --length of intensive care and hospital stay;Primary end point(s): The study is powered to detect a reduction of the 30 days mortality in critically ill cardiac surgery patients from 10% to 5%. | — |
Countries
Italy
Outcome results
None listed