A randomised prospective open label, pragmatic multi-centre trial on the effect of early enteral nutrition on gut barrier permeability in severe acute pancreatitis. Patients will be randomised to receive either early enteral nutrition or standard fluid replacement.

Inclusion Criteria

• Patients aged 18 or over
• A proven diagnosis of acute pancreatitis (pain and raised enzymes or CT evidence)
• SIRS or organ failure (Marshall score 2 or more for any organ system except liver), present for 24 hours or more, or (if available) a CT with Balthazar Severity Index >4 (>30% necrosis and/or 2 extrapancreatic fluid infiltrates).
• Randomization must be within 72 hours of onset of symptoms

Table: Marshall score. Yellow cells meet the inclusion criteria

Organ System	Sequential Organ Failure Assessment Score
	0	1	2	3	4
Respiratory PaO2/FIO2	>400	≤400	≤300	≤200*	≤100*
Renal creatinine, μmol/L	≤110	110-170	171-299	300-440 Urine output ≤500 mL/day	>440 Urine output <200 mL/day
Hepatic bilirubin, μmol/L	≤20	20-32	33-101	102-204	>204
Cardiovascular hypotension	No hypotension	MAP <70 mm Hg	Dopamine ≤5† Dobutamine (any dose)	Dopamine >5† or epinephrine ≤0.1† or norepinephrine ≤0.1†	Dopamine >15† or epinephrine >0.1† or norepinephrine >0.1†
Haematologic platelet count, x10¹²/L	>150	≤150	≤100	≤50	≤20
Neurologic Glasgow Coma score	15	13-14	10-12	6-9	<6

MAP, mean arterial pressure; * Requires the use of respiratory support; † adrenergic agents administered ≥1 hr (doses are in μg/kg/min).

Patient Exclusions

• Acute pancreatitis due to surgery, trauma or cancer
• Recurrent episodes of chronic pancreatitis
• Cholangitis
• Patients on TPN
• Inability to give informed consent
• Pregnancy
• Malignancy
• Patients taking part in another interventional trial

If you require any help, please contact: Hemant Kocher Tel: +44 (0) 20 7014 0400 ISRCTN 12838218

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