Contact information
Type
Scientific
Primary contact
Mr Simon Galloway
ORCID ID
Contact details
Department of Surgery
South Manchester University Hospitals NHS Trust
Wythenshawe Hospital
Southmoor Road
Manchester
M23 9LT
United Kingdom
+44 (0)161 291 2404/5
Simon.Galloway@smuht.nwest.nhs.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N0226121484
Study information
Scientific title
Acronym
Study hypothesis
Either anti-oxidants are of benefit in acute pancreatitis in which case all patients with severe disease should have the benefit of this therapy or they are of no benefit and should no longer be used.
Ethics approval
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
Pancreatitis
Intervention
Multi-centre, randomised double-blind placebo-controlled trial:
Group A - Maximal conventional therapy plus intravenous anti-oxidants for 7 days
Group B - Maximal conventional therapy plus placebo
Intervention type
Supplement
Phase
Not Applicable
Drug names
N-acetylcysteine, selenium, vitamin C
Primary outcome measure
Change in multiple organ dysfunction score.
Secondary outcome measures
Not provided at time of registration
Overall trial start date
03/02/2003
Overall trial end date
03/02/2005
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
In total 150 patients with predicted severe acute pancreatitis and approx 75 controls will be recruited over the four centres. Approximately 30 patients at SMUHT.
Participant type
Patient
Age group
Not Specified
Gender
Not Specified
Target number of participants
225
Participant exclusion criteria
Not provided at time of registration
Recruitment start date
03/02/2003
Recruitment end date
03/02/2005
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Department of Surgery
Manchester
M23 9LT
United Kingdom
Sponsor information
Organisation
Department of Health (UK)
Sponsor details
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
South Manchester University Hospitals NHS Trust (SMUHT) (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
Results in http://www.ncbi.nlm.nih.gov/pubmed/17356040
Publication citations
-
Results
Siriwardena AK, Mason JM, Balachandra S, Bagul A, Galloway S, Formela L, Hardman JG, Jamdar S, Randomised, double blind, placebo controlled trial of intravenous antioxidant (n-acetylcysteine, selenium, vitamin C) therapy in severe acute pancreatitis., Gut, 2007, 56, 10, 1439-1444, doi: 10.1136/gut.2006.115873.