Open-label study on the effects of the start of parenteral nutrition in intensive cardiac surgery

A Phase III randomized, controlled, open-label on the effects of parenteral nutrition early start to the late start in the ICU cardiac surgery

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2014-003197-16-IT

Enrollment

Unknown

Registered

2014-08-28

Start date

2014-12-10

Completion date

Unknown

Last updated

2016-08-22

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

Conditions

Patients undergoing or awaiting palliative / corrective pediatric cardiac surgery who should receive parenteral nutrition

Interventions

Trade Name: FREAMINE Product Name: Freamina Pharmaceutical Form: Solution for infusion Trade Name: Glucose 50% Product Name: Glucose 50% Pharmaceutical Form: Solution for infusion Trade Name: Intral

Eligibility

Sex/Gender

All

Inclusion criteria

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

Exclusion criteria: - Patients with associated malformations - Patients with coagulopathies

Design outcomes

Primary

Measure	Time frame
Primary end point(s): Incidence of nosocomial infections in the group started late in relation to the NPT NPT group started early.;Timepoint(s) of evaluation of this end point: 24 months;Main Objective: Compare the effect of early initiation of NPT (within 2 days of arrival in the ICU) with a late start after 5 days of hospitalization in intensive care on the incidence of nosocomial infections and complications incurred during hospitalization.;Secondary Objective: Assess whether the NPT late is associated with a reduction in) the length of mechanical ventilation (16), b) the duration of ICU stay (3), c) the reduction of the indices of cholestasis	—

Measure

Time frame

Primary end point(s): Incidence of nosocomial infections in the group started late in relation to the NPT NPT group started early.;Timepoint(s) of evaluation of this end point: 24 months;Main Objective: Compare the effect of early initiation of NPT (within 2 days of arrival in the ICU) with a late start after 5 days of hospitalization in intensive care on the incidence of nosocomial infections and complications incurred during hospitalization.;Secondary Objective: Assess whether the NPT late is associated with a reduction in) the length of mechanical ventilation (16), b) the duration of ICU stay (3), c) the reduction of the indices of cholestasis

—

Secondary

Measure	Time frame
Secondary end point(s): Significant reduction in duration of mechanical ventilation and the duration of degenza.Riduzione indices of cholestasis (3) in the group NPT NPT betrayed to the group early.;Timepoint(s) of evaluation of this end point: 24 months	—

Countries

Italy

Contacts

Public ContactDr. Claudia Iacoella

Bambino Gesù Children's Hospital

claudia.iacoella@opbg.net00390668592258

Outcome results

None listed

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