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Randomised prospective multicentre trial on the effect of early enteral nutrition on gut barrier permeability in severe acute pancreatitis

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN12838218
Enrollment
66
Registered
2005-03-01
Start date
2005-05-01
Completion date
Unknown
Last updated
2015-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Severe acute pancreatitis Digestive System Acute pancreatitis

Interventions

Group one: Enteral nutrition via nasogastric/nasojejunal tube, or sip feed, composition as stratified for each centre. To start immediately after randomisation. Group two: ?Standard? fluid replacemen

Sponsors

Barts and the London NHS Trust (UK)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Patients aged 18 or over with a proven diagnosis of acute pancreatitis (pain and raised enzymes or computed tomography [CT] evidence) together with systemic inflammatory response syndrome (SIRS) or organ failure (Marshall score 2 or more for any organ system except liver, or Atlanta criteria) present for 24 hours or more, and within 72 hours of onset of symptoms.

Exclusion criteria

Exclusion criteria: Not provided at time of registration

Design outcomes

Primary

MeasureTime frame
Reduction of proportion of patients with increased gut permeatbility from 80% by half to 40%.

Secondary

MeasureTime frame
1. Reduction in persistent organ failure (3 days) from 35% to 15% 2. Complications (with specific emphasis on infective complications). 3. Length of hospital/ICU stay 4. Return of normal GI function 5. Markers of intestinal ischaemia (Intestinal fatty acid binding protein) and other markers of gut permeability (endocAb), immune/inflammatory response

Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026