Impact of early parenteral nutrition completing enteral nutrition in adult critically ill patients - EPaNIC

Phase 1

• Conditions: Critical Illness; MedDRA version: 9.1Level: LLTClassification code 10063889Term: Oral intake reduced; MedDRA version: 9.1Level: LLTClassification code 10041954Term: Starvation

• Registration Number: EUCTR2007-000169-40-BE
• Lead Sponsor: Catholic University Leuven

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2007-03-26
• Study Completion: 2011-08-11
• Last Update Posted: 14 March 2022

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 9280

Inclusion Criteria

Patients older than 18 years admitted to any of the 6 intensive care units will be eligible for inclusion in the study, on condition that the nutritional risk screening (NRS)score is higher or equal to 3.
Are the trial subjects under 18? no
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) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Patients meeting the following criteria will be excluded:
Patients with a DNR code at the time of admission
Patients expected to die within 12 hours
Patients readmitted to ICU after randomization to the EPaNIC trial
Patients already enrolled in another trial
Patients transferred from another intensive care unit with an established nutritional therapy.
Patients suffering from ketoacidotic or hyperosmolar coma on admission
Patients with a BMI below than 17 kg/m2
Patients known to be pregnant or nursing.
Patients suffering from short bowel syndrome
NRS score less than 3
Patients not critically ill on admission (patients ready for oral nutrition or no indication for central venous line)

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified