Plain English Summary
Background and study aims
Acute pancreatitis is a serious condition where the pancreas becomes inflamed over a short period of time. Treatment usually involves admission to hospital where a feeding tube is inserted through the nose and into the stomach to provide patients with nutrients. This is known as enteral feeding. The aim of this study is to find out whether starting enteral feeding early is beneficial to patients with acute pancreatitis.
Who can participate?
Patients aged over 18 with acute pancreatitis
What does the study involve?
Participants are randomly allocated to one of two groups. Group A receives enteral feeding within 24 hours of admission to hospital. Group B receives no enteral feeding in the first 24 hours of hospital admission. Intravenous glucose (given into a vein) or total parenteral nutrition (all nutrients given directly into the bloodstream) are also provided if needed. Organ failure, death rates and pancreatic necrosis (infection), length of hospital stay and pain are measured in both groups daily during the study and at 1-month follow up.
What are the possible benefits and risks of participating?
There are no risks involved with early enteral feeding.
Where is the study run from?
University of Pécs (Hungary)
When is the study starting and how long is it expected to run for?
January 2017 to January 2020
Who is funding the study?
University of Pécs (Hungary)
Who is the main contact?
Prof. Peter Hegyi
p.hegyi@tm-pte.org
Study website
Contact information
Type
Scientific
Contact name
Prof Peter Hegyi
ORCID ID
Contact details
Szigeti Street 12
Pécs
7624
Hungary
+36 (0)703 751 031
p.hegyi@tm-pte.org
Additional identifiers
EudraCT/CTIS number
IRAS number
ClinicalTrials.gov number
Protocol/serial number
-
Study information
Scientific title
High versus low energy administration in the early phase of acute pancreatitis: a multicentre randomized double-blind clinical trial
Acronym
GOULASH
Study hypothesis
Researchers showed that enteral feeding is beneficial compared to a nil per os diet not only in severe, but also in mild and moderate AP. This study will provide the first evidence concerning the necessity of early energy supply.
Ethics approval(s)
Medical Research Council – Scientific and Research Ethics Committee, 25/10/2016 - approval pending
Study design
Randomised controlled two-arm double-blind multicentre interventional study
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Study setting(s)
Hospital
Study type
Treatment
Patient information sheet
See additional files
Condition
Acute pancreatitis
Intervention
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 completely resolved
5. No other pancreatitis-related complication requiring hospitalization is detected
One follow-up visit will take place 1 month after hospital discharge.
Severity (mild, moderate, severe), mortality and pancreatic necrosis are defined as primary endpoints, whereas several secondary endpoints such as length of hospitalization or pain, are determined to understand the finer differences between the groups. The general feasibility, safety and quality checks required for the highest quality evidence are performed.
Intervention type
Procedure/Surgery
Primary outcome measure
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 measures
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
Overall study start date
01/01/2017
Overall study end date
01/01/2023
Reason abandoned (if study stopped)
Eligibility
Participant 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
Participant type(s)
Patient
Age group
Adult
Lower age limit
18 Years
Sex
Both
Target number of participants
957
Participant 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
Recruitment start date
01/02/2017
Recruitment end date
01/12/2022
Locations
Countries of recruitment
Hungary
Study participating centre
University of Pécs
Szigeti Street 12
Pécs
7624
Hungary
Sponsor information
Organisation
University of Pécs
Sponsor details
Center for Translational Medicine
Szigeti Street 12
Pécs
7624
Hungary
0072/536-246
hegyi.peter@pte.hu
Sponsor type
Not defined
Website
http://aok.pte.hu/en/egyseg/index/150
ROR
Funders
Funder type
University/education
Funder name
University of Pécs
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
The pre-study-protocol is planned to be published. The publication date of the results is to be confirmed at a later date.
Intention to publish date
01/01/2024
Individual participant data (IPD) sharing plan
The datasets generated during and/or analysed during the current study are/will be available upon request from Prof. Péter Hegyi MD (p.hegyi@tm-pte.org).
IPD sharing plan summary
Available on request
Study outputs
Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
---|---|---|---|---|---|
Participant information sheet | 18/11/2016 | 15/06/2017 | No | Yes | |
Protocol article | protocol | 14/09/2017 | Yes | No |
Additional files
- ISRCTN63827758_PIS_18Nov16_Hungarian.pdf Uploaded 15/06/2017