A phase III, open, multicentre, randomised controlled trial comparing the clinical and cost-effectiveness of early nutritional support in critically ill patients via the parenteral versus the enteral route

Intensive Care National Audit & Research Centre (ICNARC) (UK)0 个研究点目标入组 2,400 人开始时间: 2009年4月9日最近更新: 2020年7月6日

试验速览

•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

•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)

发起方

Intensive Care National Audit & Research Centre (ICNARC) (UK)