Open-label study on the effects of the start of parenteral nutrition in intensive cardiac surgery
Phase 1
- Conditions
- Patients undergoing or awaiting palliative / corrective pediatric cardiac surgery who should receive parenteral nutrition
- Registration Number
- EUCTR2014-003197-16-IT
- Lead Sponsor
- Bambino Gesù Children's Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria
- Age 0-18 years, of both sexes;
- Parents or guardians are able to give their written informed consent and comply with study procedures;
- Patients waiting for surgery or palliative / corrective pediatric cardiac surgery;
- Patients requiring parenteral nutrition via central and peripheral, lasting a minimum of 7 days
- Written informed consent of the parents or legal guardians of patients
Are the trial subjects under 18? yes
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
- Patients with associated malformations
- Patients with coagulopathies
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method