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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ISRCTN |
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Last refreshed on:
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13 January 2015 |
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Main ID: |
ISRCTN12838218 |
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Date of registration:
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01/03/2005 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Randomised prospective multicentre trial on the effect of early enteral nutrition on gut barrier permeability in severe acute pancreatitis
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Scientific title:
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Date of first enrolment:
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01/05/2005 |
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Target sample size:
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66 |
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Recruitment status: |
Completed |
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URL:
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http://isrctn.com/ISRCTN12838218 |
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Study type:
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Interventional |
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Study design:
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Randomised controlled trial (Treatment)
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Phase:
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Countries of recruitment
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United Kingdom
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Contacts
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Name:
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Address:
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Telephone:
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Email:
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Affiliation:
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Name:
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Hemant
Kocher |
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Address:
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Department of Health National Clinician Scientist
Senior Lecturer
Tumour Biology Laboratory
Cancer Research UK Clinical Centre
Queen Mary?s School Of Medicine & Dentistry at Barts & The London
John Vane Science Centre
Charterhouse Square
EC1M 6BQ
London
United Kingdom |
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Affiliation:
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Key inclusion & exclusion criteria
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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: Not provided at time of registration
Age minimum:
Age maximum:
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Severe acute pancreatitis
Digestive System
Acute pancreatitis
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Intervention(s)
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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 replacement, oral or via intravenous line, composition as stratified for each centre.
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Primary Outcome(s)
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Reduction of proportion of patients with increased gut permeatbility from 80% by half to 40%.
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Secondary Outcome(s)
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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
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Secondary ID(s)
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PANC/EN/2005/v1
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Source(s) of Monetary Support
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Barts and the London NHS Trust (UK)
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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