Eligibility

Local study conflicts

• None

Inclusion Criteria:

• Adult patients attending A&E at or admitted to recruiting hospitals via a General Practitioner with a new diagnosis* of acute pancreatitis (AP) established by two of:
  1. typical continuous upper abdominal pain;
  2. amylase and/or lipase three or more times the upper limit of normal;
  3. characteristic findings on abdominal imaging (if undertaken urgently by CT or magnetic resonance imaging, MRI);
• and
• 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
• Patients from whom appropriate consent is obtained (consent to be given by the patient or their legal representative).



• * Not readmission for continuing AP from a previous diagnosis of AP
• † Every effort should be made to start the trial infusion as soon as possible after admission. The 36-hour window allows inclusion of patients identified too late on their day of admission to have trial medication prepared in time for trial infusion to be started on the day of admission.

Exclusion Criteria:

• Age <18 or >85.
• Patients with a bodyweight of over 200 kilograms.
• Known previous AP diagnosed within the last 30 days* or known chronic pancreatitis.
• Known multiple sclerosis, systemic vasculitis, Guillain-Barré syndrome or other demyelinating disorder.
• Known epilepsy.
• Moderate to severe heart failure and/or coronary heart disease (New York Heart Association† (NYHA) Functional Class III/IV).
• Known severe respiratory conditions including cystic fibrosis, severe asthma and severe chronic obstructive pulmonary disease (COPD), on home oxygen or home mechanical ventilation‡.
• Jaundice (serum bilirubin >50 μmol/L), and/or alanine aminotransferase five or more times the upper limit of normal, and/or known advanced liver disease, on waiting list for liver transplantation or considered unsuitable for transplantation.
• Known cancer for which chemotherapy and/or radiotherapy is ongoing or was completed within less than 6 months from admission.
• Known haematological malignancy.
• Known cancer that is end-stage with ongoing palliative care or for which palliative care is appropriate.
• Known established infection prior to or suspected infection, including COVID-19§, at the time of AP onset.
• Known history of (including that identified on chest x-ray) or household contact with individuals who have tuberculosis or opportunistic infection.
• Known history of infective hepatitis
• 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**.
• Known immunosuppressive or biologic therapy within one month of admission.
• Known live vaccines or therapeutic infectious agents within one month of admission.
• Known hypersensitivity to infliximab or to inactive components of REMICADE® or to any murine proteins.
• Known pregnancy or lactation at the time of admission.
• 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.
• 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.
• * Patients with a known previous diagnosis of AP made outside this 30-day period can be included provided they have a new diagnosis of a new attack of AP and are not being readmitted for continuing AP from a previous diagnosis of AP.

If the patient is eligible:

• Gain verbal agreement in principle before proceeding. Explain:
• Taking part in research is likely to improve the quality of their care
• Risks are carefully controlled - research is safe
• Explain the uncertainty that exists with respect to treatment of their condition
• If they change their mind they can withdraw their participation at any point

Step-by-Step Guide to Recruitment:

In the working hours of the research team:

• Monday-Friday 07:30 – 18:30


• Contact the EMROx research team on:
  Mobile 0776818242
  Tel 01865 222003
  Bleep 6680

Out of hours and weekends:

• Patients can only be recruited during the research team's working hours.

Out of hours and weekends:

• Patients are not being recruited

Links for further information:

Link to trial site