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Sterofundin vs Normale Saline for intraoperative fluid therapy in children aged under 36 months, undergoing surgery - Sterofundin Study

Sterofundin vs Normale Saline for intraoperative fluid therapy in children aged under 36 months, undergoing surgery - Sterofundin Study

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2010-019913-12-IT
Enrollment
Unknown
Registered
2010-04-22
Start date
2010-06-16
Completion date
Unknown
Last updated
2012-03-19

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

Conditions

Need for intraoperative fluid therapy MedDRA version: 9.1 Level: SOC Classification code 10042613

Interventions

Trade Name: STEROFUNDIN*INF 1FL 500ML Pharmaceutical Form: Solution for infusion INN or Proposed INN: SODIO CLORURO CAS Number: 7647-14-5 Concentration unit: ml millilitre(s) Concentration type: equal

Sponsors

ISTITUTO GIANNINA GASLINI
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

Exclusion criteria: Age more than 36 months Duration of surgery less than 60 min Cardiac failure Renal failure

Design outcomes

Primary

MeasureTime frame
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—

Countries

Italy

Outcome results

None listed

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