Acute pancreatitis Digestive System Acute pancreatitis
Conditions
Interventions
Current interventions:
Participants will be randomised using an online web randomisation system, by a delegated member of the research team to receive a single, 2-hour infusion of either:
Arm A: 5 mg/
Sponsors
University of Liverpool
Eligibility
Sex/Gender
All
Age
18 Years to 85 Years
Inclusion criteria
Inclusion criteria: Current participant inclusion criteria as of 01/07/2026: 1. Adult patients attending A&E at or admitted to recruiting hospitals via a General Practitioner with a new diagnosis of AP established by two of: 1.1. Typical continuous upper abdominal pain 1.2. Amylase and/or lipase three or more times the upper limit of normal 1.3. Characteristic findings on abdominal imaging (if undertaken urgently by CT or magnetic resonance imaging, MRI);? and 2) Patients in whom trial treatment can be started as soon as possible and within 36 hours of admission, allowing 120 min within the 36-hour period for preparation of trial medication; and 3) Patients from whom appropriate consent is obtained (consent to be given by the patient or their legal representative). Previous participant inclusion criteria as of 14/08/2018: 1. Adult patients attending A&E at or admitted to recruiting hospitals via a general practitioner with a new diagnosis of AP established by two of: 1.1. Typical continuous upper abdominal pain 1.2. Amylase and/or lipase three or more times the upper limit of normal; 1.3. Characteristic findings on abdominal imaging (if undertaken urgently by CT or magnetic resonance imaging, MRI); 2. Patients in whom trial treatment can be started within 12 hours of recorded admission and allowing 120 min for pharmacy to prepare trial medication 3. Patients from whom appropriate consent is obtained (consent to be given by the patient or their legal representative). Previous participant inclusion criteria: 1. Adult patients attending A&E at recruiting centres from whom appropriate consent is obtained (consent to be given by the patient or their legal representative) 2. Patients in whom trial treatment can be started within 12 hours of admission (allowing 120 min for Pharmacy to prepare trial medication) 3. A new diagnosis of AP (all severity levels) as established by two of: 3.1. Typical continuous upper abdominal pain 3.2. Amylase and/or lipase three or more times the upper limit of normal 3.3. Characteristic findings on abdominal imaging (if undertaken urgently) NB Please note all severity levels of AP are to be included in the trial
Exclusion criteria
Exclusion criteria: Current exclusion criteria as of 01/07/2026: 1. Age 85 2. Patients with a body weight of over 200 kilograms 3. Known previous AP diagnosed within the last 30 days or known chronic pancreatitis 4. Known multiple sclerosis, systemic vasculitis, Guillain-Barré syndrome or other demyelinating disorder 5. Known epilepsy 6. Moderate to severe heart failure and/or coronary heart disease (New York Heart Association (NYHA) Functional Class III/IV) 7. Known severe respiratory conditions, including cystic fibrosis, severe asthma and severe chronic obstructive pulmonary disease (COPD), on home oxygen or home mechanical ventilation 8. Jaundice (serum bilirubin >50 µmol/L), and/or known advanced liver disease, on waiting list for liver transplantation or considered unsuitable for transplantation 9. Known cancer for which chemotherapy and/or radiotherapy is ongoing or was completed within less than 6 months from admission 10. Known haematological malignancy 11. Known cancer that is end-stage with ongoing palliative care or for which palliative care is appropriate 12. Known established infection prior to or suspected infection, including COVID-19§, at the time of AP onset 13. Known history of (including that identified on chest x-ray) or household contact with individuals who have tuberculosis or opportunistic infection 14. Known history of infective hepatitis (unless recovered from previous hepatitis A) 15. Known rare diseases or inborn errors of metabolism that significantly increase the risk of infections, including severe combined immunodeficiency (SCID) and homozygous sickle cell disease 16. Known immunosuppressive or biologic therapy within one month of admission 17. Known live vaccines or therapeutic infectious agents within one month of admission 18. Known hypersensitivity to infliximab or to inactive components of infliximab or to any murine proteins 19. Known pregnancy or lactation at the time of admission 20. Women of childbearing potential who do not agree to use adequate contraception (includes prior surgical sterilisation; birth control pill, patch or injection; intrauterine device; male or female condom (but not both); female cap with spermicide or total sexual abstinence; but not periodic abstinence, withdrawal or spermicides only), up to 6 months after trial infusion treatment 21. Known to be currently participating in a trial testing any investigational medicinal product or participation in a clinical study involving a medicinal product in the last three months Previous key exclusion criteria: 1. Age 85 2. Body weight > 200 kg 3. Onset of abdominal pain more than 24 hours before admission to the hospital 4. Known previous acute pancreatitis or chronic pancreatitis 5. Known multiple sclerosis, systemic vasculitis, Guillain-Barré syndrome or other demyelinating disorder 6. Known epilepsy 7. Moderate to severe heart failure and/or coronary heart disease (New York Heart Association (NYHA) Functional Class III/IV) 8. On home oxygen or home mechanical ventilation 9. Known advanced liver disease, on waiting list for liver transplantation or considered unsuitable for transplantation 10. Known cancer for which chemotherapy and/or radiotherapy is ongoing or was completed within less than 6 months from admission 11. Known haematological malignancy 12. Known cancer that is end-stage with ongoing palliative care or for which palliative care is appropriate 13. Known established infection prior to the onset of acute pancreatiti
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mean serum C-reactive protein in either active arm (5 mg/kg or 10 mg/kg) versus the placebo arm measured using standard methods (summated as area under the curve) at Days 2, 4 (+/- 1 day) and 14 (+/- 2 days);Previous primary outcome as of 01/07/2026: The primary efficacy outcome measure will be the difference in mean serum C-reactive protein measured on Days 2, 4, 7, 14 and 28 (summated as area under the curve) in either active arm (5 mg/kg or 10 mg/kg) versus the placebo arm; Timepoint(s): End of the study | — |
Secondary
| Measure | Time frame |
|---|---|
| Current key secondary outcomes as of 01/07/2026: 1. Cumulative pain score measured using a numerical rating scale (between 0-10) for the first 28 days 2. Opiate requirements measured using the recording of daily morphine equivalents for the first 28 days 3. Nutritional deficit measured using the recording of the number of days without solid food for the first 28 days 4. Decline in serum albumin (negative AUC) measured using blood samples for the first 28 days 5. Rise in neutrophils (AUC) measured using blood samples for the first 28 days 6. Organ function, disease progression, and mortality risk measured using the cumulative Sequential Organ Failure Assessment (SOFA) score for the first 28 days 7. Local pancreatic injury measured using contrast-enhanced computerised tomography scan (CECT day 14 +/- 7 days) 8. Infection measured using selected data collection up until day 90 9. Length of stay measured using selected data collection up until day 90 10. Mortality measured using selected data collection up until day 90 11. Patient reported outcome measured using the EQ-5D-5L on Days 4 (+/- 1 day), 14 (+/- 2 days) and 90 (+/- 7 days). Previous key secondary outcomes: 1. Cumulative Pain Scores: patients will complete a numerical rating scale (between 0-10) for the first 28 days 2. Opiate requirements: recording of daily morphine equivalents for the first 28 days 3. Nutritional deficit: number of days nil by mouth +/- nutritional support for the first 28 days 4. Decline in serum albumin, measured via blood samples for the first 28 days 5. Decline in haematocrit, measured via blood samples for the first 28 days 6. Rise in neutrophils, measured via blood samples for the first 28 days 7. Presence and duration of systemic inflammatory response syndrome, present (duration of response) or absent, for the first 28 days 8. Cumulative serial organ failure assessment (SOFA score) for the first 28 days 9. Local pancreatic injury, measured using a contrast-enhanced CT scan, assessed | — |
Countries
England, Scotland, United Kingdom, Wales
Outcome results
None listed