Topic: Oral and Gastrointestinal
Conditions
Interventions
1. High rate parenteral nutrition: 48 hours of higher rates of feeding - 30 kcal/kg/day (including protein), 0.25 gN/kg/day
2. Low rate parenteral nutrition: 48 hours of lower rates of feeding - 15 kc
Sponsors
Southampton University Hospitals NHS Trust (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. All consenting patients (minimum 18 years old, either sex) who require intravenous nutrition as assessed by the Southampton University Hospitals NHS Trust and the Royal Berkshire NHS Foundation Trust Nutrition Support Teams 2. Patients who do not require specialised parenteral nutrition regimens to meet their clinical needs 3. Patients who are at moderate or high risk of refeeding syndrome as defined by: 3.1. Moderate risk (one of the following criteria): 3.1.1. Body mass index (BMI) less than 18.5 kg/m^2 3.1.2. Unintentional weight loss greater than 10% in 3 - 6 months 3.1.3. Very little or no food intake for greater than 5 days 3.2. High risk (one of the following criteria): 3.2.1. BMI less than 16 kg/m^2 3.2.2. Unintentional weight loss greater than 15% 3.2.3. Very little nutritional intake for greater than 10 days Or Two of the following lesser criteria: 3.2.4. BMI less than 18.5 kg/m^2 3.2.5. Weight loss greater than 10% 3.2.6. Very little nutritional intake for greater than 5 days
Exclusion criteria
Exclusion criteria: 1. Patients at very high risk of re-feeding syndrome (two or more of the NICE criteria: BMI less than 16 kg/m^2, recent weight loss greater than 15% body weight within 6 months, greater than 10 days with no nutritional intake) or patients with a BMI less than 14 kg/m^2) 2. Levels of K/Mg/PO4 below lower limit of normal (LLN) range from the SUHT chemical pathology laboratory prior to feeding 3. Patients with oral nutritional intake 4. Intensive care patients (who often receive variable levels of additional enteral tube feeding) 5. Patients weighing 80 kg or more giving them an estimated energy requirement above 2400 kcal/day (as we feel giving patients more than 2400 kcal/day poses too great a risk) 6. Patients with pre-existing diabetes mellitus 7. Patients unable to give informed consent to take part
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Refeeding Syndrome, measured within 1 week of randomisation | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Clinical evidence of fluid overload, measured at day 2 of trial 2. Infective complications, measured within 1 week of randomisation 3. Intracellular electrolyte disturbance, measured on day 3 4. Length of stay, measured on day of discharge 5. Supplemental electrolyte prescription, measured within 1 week of randomisation | — |
Countries
United Kingdom
Outcome results
None listed