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

• Register: ISRCTN
• Last refreshed on: 21 January 2020
• Main ID: ISRCTN63827758
• Date of registration: 03/01/2017
• Prospective Registration: Yes
• Primary sponsor: University of Pécs
• Public title: Is early energy supply to patients suffering from acute pancreatitis beneficial?
• Scientific title: High versus low energy administration in the early phase of acute pancreatitis: a multicentre randomized double-blind clinical trial
• Date of first enrolment: 01/02/2017
• Target sample size: 957
• Recruitment status: Ongoing
• URL: http://isrctn.com/ISRCTN63827758
• Study type: Interventional
• Study design: Randomised controlled two-arm double-blind multicentre interventional study; (Treatment)
• Phase: Not Applicable

Countries of recruitment

Hungary

Contacts

• Name: Peter Hegyi

Key inclusion & exclusion criteria

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
10. Ketoacidosis
11. Whenever CT with contrast is contraindicated


Age minimum:
Age maximum:
Gender: Both

Health Condition(s) or Problem(s) studied

Acute pancreatitis
Digestive System
Acute pancreatitis

Intervention(s)

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 Entera

Primary Outcome(s)

1. Multi organ failure persisting for more than 48h, measured by clinical assessment at admission, daily during the study and at 1-month follow up
3. Mortality, measured at admission, daily during the study and at 1-month follow up

Secondary Outcome(s)

1. Pancreatic necrosis, measured by CT at admission, daily during the study and at 1-month follow up
2. Nutrition related complications: diarrhoea, aspiration pneumonia, pneumothorax due to central TPN catheter placement, measured by clinical assessment at admission and daily during the study
3. Need for conversion from NG to NJ feeding tube, measured by clinical assessment at admission and daily during the study
4. Need for conversion from enteral nutrition (EN) to total parenteral nutrition (TPN), measured by clinical assessment at admission and daily during the study
5. Days until the start of total feeding, measured daily during the study
6. Use of antibiotics, measured daily during the study
7. Pain relapse, measured using the VAS scale daily during the study
8. C-reactive protein (CRP), measured by laboratory test daily during the study
9. White blood cell (WBC) count, measured by laboratory test daily during the study
10. Procalcitonin (PCT), measured by laboratory test daily during the study
11. Infection, measured by microbiological test daily during the study
12. Length of hospital stay, measured daily during the study
13. Need for ICU admission, measured at admission and daily during the study
14. Length of ICU therapy, measured at admission and daily during the study
15. Organ failure, measured at admission and daily during the study
16. Complications, measured at admission, daily during the study and at 1-month follow up
17. Costs calculation

Source(s) of Monetary Support

University of Pécs

Ethics review

Status:
Approval date:
Contact:

Medical Research Council – Scientific and Research Ethics Committee, 25/10/2016 - approval pending

Results

• Results available: Yes
• Date Completed: 01/01/2023