Refeeding risks in patients requiring nutrition support. A twin centre double-blind randomised controlled trial of parenteral nutrition support. - Refeeding risks in patients requiring nutrition support

Southampton University Hospital NHS Trust0 个研究点目标入组 230 人开始时间: 2010年6月24日最近更新: 2012年3月19日

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•1.All consenting adults or those for whom consent can be gained from a close family member/friend or professional legal representative (minimum 18 years old) who require intravenous nutrition as assessed by the Southampton University Hospitals NHS Trust and the Royal Berkshire NHS Foundation Trust Nutrition Support Teams.
•2.Who do not require specialised parenteral nutrition regimens to meet their clinical needs.
•3.Who are at moderate or high risk of refeeding problems as defined by:
•Moderate risk: 1 of the following criteria - BMI <18.5 kg/m2, unintentional weight loss >10% in 3-6 months or very little or no food intake for >5days.
•High risk: 1 of the following criteria - BMI <16 kg/m2, unintentional weight loss >15%, very little nutritional intake for >10 days; or 2 of the following lesser criteria - BMI <18.5 kg/m2; weight loss >10%; very little nutritional intake for >5 days.
•Are the trial subjects under 18? no
•Number of subjects for this age range: 0
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 115
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 115

•Patients at very high risk of re-feeding syndrome (2 or more of the NICE criteria (BMI<16, recent weight loss >15% body weight within-6 months, > 10 days with no nutritional intake) or patients with a BMI < 14))
•If after careful clinical assessment the investigator feels that the patient is not at an unusually high risk from refeeding, they can be considered for inclusion if:
•Magnesium level no greater than 0.2mmol below lower limit of normal
•Phosphate level no greater than 0.2mmol below lower limit of normal
•Potassium level no greater than 0.5mmol below lower limit of normal
•Patients with established oral nutritional intake
•Patients weighing 100kg or more, after adjusting for oedema.

发起方

Southampton University Hospital NHS Trust