Is early energy supply to patients suffering from acute pancreatitis beneficial?
| ISRCTN | ISRCTN63827758 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN63827758 |
- Submission date
- 08/11/2016
- Registration date
- 03/01/2017
- Last edited
- 07/01/2020
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Digestive System
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
Contact information
Scientific
Szigeti Street 12
Pécs
7624
Hungary
| Phone | +36 (0)703 751 031 |
|---|---|
| p.hegyi@tm-pte.org |
Study information
| 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 |
| Participant information sheet | ISRCTN63827758_PIS_18Nov16_Hungarian.pdf |
| Scientific title | High versus low energy administration in the early phase of acute pancreatitis: a multicentre randomized double-blind clinical trial |
| Study 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 |
| 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 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 957 |
| 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 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
Pécs
7624
Hungary
Sponsor information
Not defined
Center for Translational Medicine
Szigeti Street 12
Pécs
7624
Hungary
| Phone | 0072/536-246 |
|---|---|
| hegyi.peter@pte.hu | |
| Website | http://aok.pte.hu/en/egyseg/index/150 |
"ROR" |
https://ror.org/037b5pv06 |
Funders
Funder type
University/education
No information available
Results and Publications
| Intention to publish date | 01/01/2024 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| 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. |
| 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). |
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
Editorial Notes
07/01/2020: The following changes have been made:
1. The recruitment end date has been changed from 01/12/2019 to 01/12/2022.
2. The overall trial end date has been changed from 01/01/2020 to 01/01/2023.
3. The intention to publish date has been changed from 01/01/2021 to 01/01/2024.
18/09/2017: Publication reference added.
15/06/2017: Participant information sheet uploaded.
