Sterofundin vs Normale Saline for intraoperative fluid therapy in children aged under 36 months, undergoing surgery - Sterofundin Study
- Conditions
- eed for intraoperative fluid therapyMedDRA version: 9.1Level: SOCClassification code 10042613
- Registration Number
- EUCTR2010-019913-12-IT
- Lead Sponsor
- ISTITUTO GIANNINA GASLINI
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria
Age less than 36 months ASA I-III Need for intraoperative treatment with Normal Saline or Sterofundin Surgery longer than 60 minutes
Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
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
Age more than 36 months Duration of surgery less than 60 min Cardiac failure Renal failure
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: Normal Natriemic maiteinance;Secondary Objective: Effect of Sterofundin on: Plasmatic electrolitis (K, Ca, Mg, Cl); Plasmatic osmolarity Acid basis equilibrium Renal function;Primary end point(s): Sodium difference (delta Na) between pre and postoperative vaules
- Secondary Outcome Measures
Name Time Method