Impact of Early Parenteral Nutrition completing enteral nutrition In adult Critically ill patients

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN76223876

Enrollment

4640

Registered

2007-03-28

Start date

2007-08-01

Completion date

Unknown

Last updated

2019-03-25

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

Conditions

Critical Illness Signs and Symptoms

Interventions

Written informed consent will be obtained from the patient or the closest family member or legal guardian. The family member or the patient can withdraw from the trial, at any time, without impact on

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Patients admitted to any of the five intensive care units 2. Older than 18 years 3. Nutritional Risk Screening Score (NRS) score higher or equal to three upon ICU admission

Exclusion criteria

Exclusion criteria: 1. Patients with a Do Not Resuscitate (DNR) code or moribund at the time of ICU admission 2. Patients already enrolled in another trial 3. Patients transferred from another intensive care unit with an established nutritional therapy 4. Patients suffering from ketoacidotic or hyperosmolar coma on admission 5. Patients with a Body Mass Index (BMI) below 17 kg/m^2 6. Short Bowel Syndrome 7. Patients known to be pregnant or nursing 8. Patients on mechanical ventilation at home 9. NRS score lower than three Added 25/05/10: 10. Patient readmitted to ICU after randomisation to the EPaNIC trial 11. Patient not critically ill on admission (No clinical indication for central intravenous catheter or patient ready for oral nutrition on admission)

Design outcomes

Primary

Measure	Time frame
Length of stay in ICU and the hospital	—

Secondary

Measure	Time frame
Current information as of 25/05/2010: 1. Death (hospital, ICU and 90 days mortality) 2. The secondary morbidity outcomes will include: 2.1. Days to weaning from mechanical ventilation 2.2. The need for renal replacement therapies 2.3. The presence or absence of new kidney injury during intensive care 2.4. Days of vasopressor or inotropic support 2.5. The presence or absence of signs of ICU liver disease: hyperbilirubinemia (defined as bilirubin level > 3 mg/dl), presence of liversteatosis, sludge 2.6. The need for tracheotomy 2.7. The presence or absence of hyper-inflammation within five days after ICU admission 2.8. Blood lipid profiles and albumin on days one, five, ten, and 15 after admission 2.9. The presence or absence of bacteraemia, ventilator-associated pneumonia and of wound infections 2.10. Episodes of hypoglycaemic events (defined as glycemia less than 40 mg/dl) 2.11. Amount and type of calories delivered 2.12. Muscle strength and rehabilitation 2.13. Presence of clinical and electrophysiological signs of respiratory and peripheral muscle weakness Initial information at time of registration: 1. Death (hospital and ICU mortality) 2. The secondary morbidity outcomes will include: 2.1. Days to weaning from mechanical ventilation 2.2. The need for renal replacement therapies 2.3. The presence or absence of new kidney injury during intensive care 2.4. Days of vasopressor or inotropic support 2.5. The presence or absence of hyperbilirubinemia and liversteatosis 2.6. The need for tracheotomy 2.7. The presence or absence of hyper-inflammation within five days after ICU	—

Measure

Time frame

Current information as of 25/05/2010: 1. Death (hospital, ICU and 90 days mortality) 2. The secondary morbidity outcomes will include: 2.1. Days to weaning from mechanical ventilation 2.2. The need for renal replacement therapies 2.3. The presence or absence of new kidney injury during intensive care 2.4. Days of vasopressor or inotropic support 2.5. The presence or absence of signs of ICU liver disease: hyperbilirubinemia (defined as bilirubin level > 3 mg/dl), presence of liversteatosis, sludge 2.6. The need for tracheotomy 2.7. The presence or absence of hyper-inflammation within five days after ICU admission 2.8. Blood lipid profiles and albumin on days one, five, ten, and 15 after admission 2.9. The presence or absence of bacteraemia, ventilator-associated pneumonia and of wound infections 2.10. Episodes of hypoglycaemic events (defined as glycemia less than 40 mg/dl) 2.11. Amount and type of calories delivered 2.12. Muscle strength and rehabilitation 2.13. Presence of clinical and electrophysiological signs of respiratory and peripheral muscle weakness Initial information at time of registration: 1. Death (hospital and ICU mortality) 2. The secondary morbidity outcomes will include: 2.1. Days to weaning from mechanical ventilation 2.2. The need for renal replacement therapies 2.3. The presence or absence of new kidney injury during intensive care 2.4. Days of vasopressor or inotropic support 2.5. The presence or absence of hyperbilirubinemia and liversteatosis 2.6. The need for tracheotomy 2.7. The presence or absence of hyper-inflammation within five days after ICU

—

Countries

Belgium

Outcome results

None listed

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