Enteral/parenteral feeding Nutritional, Metabolic, Endocrine Enteral/parenteral feeding
Conditions
Interventions
Current interventions as of 08/01/2013:
Early PN versus early EN within 36 hours of the date/time of original admission to a critical care unit.
The protocol for PN (i
Sponsors
Intensive Care National Audit & Research Centre (ICNARC) (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Current inclusion criteria as of 08/01/2013: Patients who either on, or soon after admission (but within a timeframe to consent/obtain agreement, randomise and start nutritional support within 36 hours of the date/time of original admission to a critical care unit) are: 1. Adult (defined as age 18 years or over) 2. An unplanned admission (including planned admissions becoming unplanned e.g. unexpected post-operative complications) 3. Expected to receive nutritional support for two or more days in the unit 4. Not planned to be discharged within three days (defined by clinical judgment) from the unit Previous inclusion criteria until 08/01/2013: 1. Male and female adults (defined as age 18 years or over) 2. Unplanned admission (defined as per the Critical Care Minimum Data Set [CCMDS] 3. Original critical care unit admission (defined as not transferred in from another critical care unit/bed) 4. Not planned to discharge within three days (defined by clinical judgment) 5. Not expected to receive oral feeding within two days
Exclusion criteria
Exclusion criteria: Current exclusion criteria as of 08/01/2013: 1. Patients who have been in a critical care unit for more than 36 hours (i.e. from the date/time of original admission to a critical care unit) 2. Patients previously randomised into CALORIES 3. Patients with pre-existing contraindications to PN or EN 4. Patients who have received PN or EN within the last seven days 5. Patients admitted with a percutaneous endoscopic gastrostomy, percutaneous endoscopic jejunostomy, needle/surgical jejunostomy or nasojejunal tube in situ 6. Patients admitted to the critical care unit for treatment of thermal injury (burns) 7. Patients admitted to the critical care unit for palliative care 8. Patients whose expected stay in the UK is less than six months 9. Women who are pregnant Previous exclusion criteria until 08/01/2013: 1. Pre-existing contraindication to ETF or PN 2. Pregnant women 3. People whose expected stay in the UK is less than six months 4. Patients admitted to the unit for treatment of thermal injury (burns) 5. Patients admitted to the unit for palliative care 6. Patients with percutaneous endoscopic gastrostomy (PEG), percutaneous endoscopic jejunostomy (PEJ) or needle/surgical jejunostomy (JEJ)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Current primary outcome measures as of 08/01/2013: 1. To estimate the effect of early (defined as within 36 hours of the date/time of original critical care unit admission) nutritional support via the parenteral route (PN) compared with the enteral route (EN) on mortality at 30 days 2. To estimate the incremental cost-effectiveness of early PN compared with EN at one year Previous primary outcome measures until 08/01/2013: 30-day all cause mortality and cost-effectiveness at one year. | — |
Secondary
| Measure | Time frame |
|---|---|
| Current secondary outcome measures as of 08/10/2013: To compare PN with EN for: 1. Duration of specific and overall organ support in the critical care unit 2. Infectious and non-infectious complications in the critical care unit 3. Duration of critical care unit and acute hospital length of stay 4. Mortality at discharge from the critical care unit and from hospital 5. Mortality at 90 days and at one year 6. Nutritional and health-related quality of life at 90 days and at one year 7. Resource use and costs at 90 days and at one year 8. Estimated lifetime incremental cost-effectiveness Previous secondary outcome measures until 08/10/2013: 1. Duration of specific and overall organ support 2. Infectious and non-infectious complications in the critical care unit 3. Duration of critical care unit and acute hospital length of stay 4. Mortality at discharge from the critical care unit and hospital 5. Mortality between 90 days and one year 6. Nutritional and health-related quality of life at 90 days and at one year 7. Resource use and costs at 90 days and one year | — |
Countries
United Kingdom
Outcome results
None listed