Patients candidate to cardiac surgery MedDRA version: 9.1 Level: SOC Classification code 10007541 Term: Cardiac disorders
Conditions
Interventions
Product Name: Insulin (human)
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: Insulin (human)
Concentration unit: IU international unit(s)
Concentration type: equal
Concentration num
Sponsors
AZIENDA OSPEDALIERA OSPEDALE POLICLINICO CONSORZIALE
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients candidate to cardiac surgery 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) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Diabetes mellitus BMI 30 kg/m2 Age 75 Infections
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Evaluation of the effect of continous insulin infusion on the PCR, pro-inflammatory cytokines such as tumor necrosis factor-alfa, IL-1, IL-6 ;Secondary Objective: Evaluation of the effect of continous insulin infusion on the infectious complications in patients undergoing cardia surgery;Primary end point(s): PCR, IL-1, IL-6, TNF-alfa levels | — |
Countries
Italy
Outcome results
None listed