Randomised double-blind placebo-controlled trial of intravenous antioxidant therapy in predicted severe pancreatitis
| ISRCTN | ISRCTN56033334 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN56033334 |
| Protocol serial number | N0226121484 |
| Sponsor | Department of Health (UK) |
| Funder | South Manchester University Hospitals NHS Trust (SMUHT) (UK) |
- Submission date
- 12/09/2003
- Registration date
- 12/09/2003
- Last edited
- 27/04/2009
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Digestive System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Mr Simon Galloway
Scientific
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 |
|---|---|
| Simon.Galloway@smuht.nwest.nhs.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| 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(s) |
Change in multiple organ dysfunction score. |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 03/02/2005 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Target sample size at registration | 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 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Department of Surgery
Manchester
M23 9LT
United Kingdom
M23 9LT
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | Results | 01/10/2007 | Yes | No |
