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Fenoldopam mesilate efficacy to control splancnic ischemia during cardiopulmonary bypass in pediatric patients - ND

Fenoldopam mesilate efficacy to control splancnic ischemia during cardiopulmonary bypass in pediatric patients - ND

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2009-009115-22-IT
Enrollment
Unknown
Registered
2009-03-10
Start date
2009-05-04
Completion date
Unknown
Last updated
2012-04-03

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

Conditions

cardiac surgery with CPB MedDRA version: 9.1 Level: SOC Classification code 10042613

Interventions

Trade Name: CORLOPAM Pharmaceutical Form: Solution for injection INN or Proposed INN: Fenoldopam Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 10-

Sponsors

ISTITUTO GIANNINA GASLINI
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: elective cardiac surgery for congenital heart disease bypass time > 60 =65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: weight > 15 Kg operation with circulatory arrest urgent/emergency operations no informed consensus

Design outcomes

Primary

MeasureTime frame
Main Objective: plasmatic lactate titration to evaluate the improvement of splancnic perfusion during CPB by Fenoldopam Mesylate administration;Secondary Objective: postoperative plasmatic lactate titration and diureris evaluation;Primary end point(s): Lactate titration at CPB end. Positive result to Fenoldopam Mesylate administration has to be considered the lactate value <2 mMol/l;—

Countries

Italy

Outcome results

None listed

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