Is early energy supply to patients suffering from acute pancreatitis beneficial?

High versus low energy administration in the early phase of acute pancreatitis: a multicentre randomized double-blind clinical trial

Registry ID
ISRCTN63827758
Source registry
ISRCTN
Status
No longer recruiting
Study type
INTERVENTIONAL
Sponsor
University of Pécs
Enrollment
957
Start date
2017-02-01
Completion date
2023-01-01
Last update
2026-08-17

Conditions

Summary

Acute pancreatitis

Detailed description

Patients suffering from acute pancreatitis are randomised by computer into two groups: Group A: high energy administration after admission Patients will receive a 10 Ch nasogastric (NG) or nasojejunal (NJ) feeding tube at admission EN will immediately started as follows: Day 0: (From admission until the start of EN (can be vary from 2-24 h)): calorie intake: 0 kcal/kg/day Day 1: High Energy Enteral Tube Feed (1.5 kcal/ml) 30 kcal/kg/day (volume cannot exceed 60 ml/h) Day 2: High Energy Enteral Tube Feed (1.5 kcal/ml) 30 kcal/kg/day Day 3: until it is necessary: High Energy Enteral Tube Feed (1.5 kcal/ml) 30 kcal/kg/day Group B: low energy administration after hospital admission Patients will receive a 10 Ch nasogastric or nasojejunal feeding tube at admission EN will immediately start Day 0: (From admission until the start of EN (can be vary from 2-24 h)): calorie intake: 0 kcal/kg/day Day 1: Zero Energy Enteral Tube Feed (0 kcal/ml) 1440 ml/day Day 2: Step Up1 Energy Enteral Tube Feed (0.50 kcal/ml) 10 kcal/kg/day (volume cannot exceed 60ml/h) Day 3: Step Up2 Energy Enteral Tube Feed (1.00 kcal/ml) 20 kcal/kg/day Day 4 (if needed): Step Up3 Energy Enteral Tube Feed (1.25 kcal/ml) 25 kcal/kg/day Day 5 (if needed): Step Up4 Energy Enteral Tube Feed (1.5 kcal/ml) 30 kcal/kg/day Day 6 (if needed): Step Up5 Energy Enteral Tube Feed (1.5 kcal/ml) 30 kcal/kg/day Day 7 (if needed): High Energy Enteral Tube Feed (1.5 kcal/ml) 30 kcal/kg/day Zero Energy Enteral Tube Feed (100ml): Energy: 0 kcal (0 KJ), Protein 0g, Carbohydrate: 0g, Fat: 0g + Minerals: 134mg Sodium, 201mg Potassium, 34mg Magnesium, 4,872 g Chloride (0%E) (in this study the local institutional pharmacy will compose it in accordance with the Hungarian regulations) 308,9 mOsm/L. Patient is counted as discharged from hospital/from the study when: 1. The total feeding was tolerated for 24h 2. No amylase/lipase level were elevated after total feeding 3. CRP level is less than 50 mg/L 4. Abdominal pain has c

Interventions

Inclusion criteria

1. Patients above 18 years of age 2. Diagnosed with acute pancreatitis on the basis of the “2 out of 3” rule of the IAP/APA guideline 3. Written informed consent form is signed

Exclusion criteria

1. Hospitalization 72 hours before admission 2. Abdominal pain >120 hours (5 days) 3. Delirium tremens 4. Child-Pugh C stage liver cirrhosis 5. AP due to malignancy 6. Already on artificial nutrition (enteral or parenteral nutrition) 7. Pregnancy 8. BMI above 40 or below 18 9. Age above 80 years 10. Ketoacidosis 11. Whenever CT with contrast is contraindicated

Locations

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