Clinical and cost-effectiveness of early nutritional support in critically ill patients via the parenteral versus the enteral route

Phase 3

Completed

• Conditions: Enteral/parenteral feeding; Nutritional, Metabolic, Endocrine

• Registration Number: ISRCTN17386141
• Lead Sponsor: Intensive Care National Audit & Research Centre (ICNARC) (UK)

Brief Summary

2014 results in http://www.ncbi.nlm.nih.gov/pubmed/25271389 2016 results in http://www.ncbi.nlm.nih.gov/pubmed/27089843 2019 results in https://pubmed.ncbi.nlm.nih.gov/30224150/ (added 24/06/2020)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2009-04-09
• Study Completion: 2013-12-31
• Last Update Posted: 6 July 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 2400

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

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)

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br> Current primary outcome measures as of 08/01/2013:<br> 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<br> 2. To estimate the incremental cost-effectiveness of early PN compared with EN at one year<br><br> Previous primary outcome measures until 08/01/2013:<br> 30-day all cause mortality and cost-effectiveness at one year.<br>