Randomised double-blind placebo-controlled trial of intravenous antioxidant therapy in predicted severe pancreatitis

ISRCTN	ISRCTN56033334
DOI	https://doi.org/10.1186/ISRCTN56033334
Secondary identifying numbers	N0226121484

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Mr Simon Galloway
Scientific

Department of Surgery
South Manchester University Hospitals NHS Trust
Wythenshawe Hospital
Southmoor Road
Manchester
M23 9LT
United Kingdom

Phone	+44 (0)161 291 2404/5
Email	Simon.Galloway@smuht.nwest.nhs.uk

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Scientific title
Study objectives	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(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	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
Primary outcome measure	Change in multiple organ dysfunction score.
Secondary outcome measures	Not provided at time of registration
Overall study start date	03/02/2003
Completion date	03/02/2005

Participant type(s)	Patient
Age group	Not Specified
Sex	Not Specified
Target number of participants	225
Key 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.
Key exclusion criteria	Not provided at time of registration
Date of first enrolment	03/02/2003
Date of final enrolment	03/02/2005

Department of Surgery

Manchester
M23 9LT
United Kingdom

Department of Health (UK)
Government

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Website	http://www.doh.gov.uk

Government

South Manchester University Hospitals NHS Trust (SMUHT) (UK)

No information available

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	Results	01/10/2007		Yes	No