Critical Illness Clinical Trial
— EPaNICOfficial title:
Impact of Early Parenteral Nutrition Completing Enteral Nutrition in Adult Critically Ill Patients
Verified date | February 2024 |
Source | KU Leuven |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
In critically ill patients, a strategy aimed at an early delivery of full caloric support, with a combination of Enteral Nutrition (EN) and Parenteral Nutrition (PN) (in conditions preventing hyperglycemia and overfeeding), results in shorter ICU and hospital stay and less morbidity as compared to a strategy using only EN.
Status | Active, not recruiting |
Enrollment | 4640 |
Est. completion date | December 2026 |
Est. primary completion date | February 2011 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 99 Years |
Eligibility | Inclusion Criteria: 1. Patients admitted to any of the five intensive care units 2. Older than 18 years 3. Nutritional risk screening score (NRS) higher or equal to three upon ICU admission 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 10. Patient readmitted to ICU after randomization 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.) |
Country | Name | City | State |
---|---|---|---|
Belgium | Surgical Intensive Care Unit Regional Hospital Jessa | Hasselt | |
Belgium | Medical Intensive Care Unit | Leuven | |
Belgium | Surgical Intensive Care Unit, Catholic University Leuven University Hospitals | Leuven |
Lead Sponsor | Collaborator |
---|---|
KU Leuven | Baxter Healthcare Corporation, Fund for Scientific Research, Flanders, Belgium |
Belgium,
van den Berghe G, Wouters P, Weekers F, Verwaest C, Bruyninckx F, Schetz M, Vlasselaers D, Ferdinande P, Lauwers P, Bouillon R. Intensive insulin therapy in critically ill patients. N Engl J Med. 2001 Nov 8;345(19):1359-67. doi: 10.1056/NEJMoa011300. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Length of stay in ICU and length of stay in the hospital. | 2 years | ||
Secondary | Death (hospital and ICU mortality and 90 days mortality) | 10 years | ||
Secondary | Days to weaning from mechanical ventilation | 2 years | ||
Secondary | The need for renal replacement therapies | 2 years | ||
Secondary | The presence or absence of new kidney injury during intensive care | 2 years | ||
Secondary | Days of vasopressor or inotropic support | 2 years | ||
Secondary | The presence or absence of signs of ICU liver disease: hyperbilirubinemia (defined as bilirubin level > 3 mg/dl), presence of liversteatosis, sludge… | 2 years | ||
Secondary | The need for tracheotomy | 2 years | ||
Secondary | The presence or absence of hyper-inflammation within five days after ICU admission | 2 years | ||
Secondary | Blood lipid profiles and albumin on days one, five, ten, and fifteen after admission | 2 years | ||
Secondary | The presence or absence of bacteraemia, ventilator-associated pneumonia and of wound infections | 2 years | ||
Secondary | Episodes of hypoglycaemic events (defined as glycemia less than 40 mg/dl) | 2 years | ||
Secondary | Amount and type of calories delivered | 2 years | ||
Secondary | Muscle strength: among others: MRCss, Maximum Inspiratory Pressure in patients staying more than 7 days in ICU and a subset staying < 7 days, as well as in individuals who have never stayed in ICU. Presence of electrophysiological signs of CIP/CIM. | 10 years | ||
Secondary | Rehabilitation/functionality: among others: six minute walking distance and activities of daily life at hospital discharge and at follow-up moments. SF 36 questionnaire at several follow-up moments and in individuals who have never stayed in ICU. | 10 years |
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