Does prophylactic administration of magnesium reduce the risk and severity of post-endoscopic retrograde cholangiopancreatography (post-ERCP) pancreatitis? A clinical study.
| ISRCTN | ISRCTN46556454 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN46556454 |
| Secondary identifying numbers | N/A |
- Submission date
- 01/03/2009
- Registration date
- 07/04/2009
- Last edited
- 12/02/2013
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Digestive System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Prof Markus Lerch
Scientific
Scientific
Klinik für Innere Medizin A
Klinikum der Ernst-Moritz-Arndt-Universität
Friedrich-Loeffler-Str. 23A
Greifswald
17475
Germany
| Phone | +49 (0)3834 867230 |
|---|---|
| lerch@uni-greifswald.de |
Study information
| Study design | Prospective randomised double-blind placebo-controlled multicentre study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Can be found at http://www.pancreas.de (German only) |
| Scientific title | Magnesium sulphate in the prevention of Post-ERCP Pancreatitis: a prospective randomised, placebo-controlled multicentre study |
| Study acronym | MagPEP |
| Study objectives | Acute pancreatitis is the most common complication of diagnostic and therapeutic endoscopic retrograde cholangiopancreatography (ERCP). Despite continuing research, no pharmacologic substance capable of effectively reducing the incidence of this complication has found its way into clinical routine. A number of experimental observations suggest that pancreatic calcium concentrations play an important role in the initiation of pancreatic protease activation, the first step in the course of acute pancreatitis. Magnesium can act as a calcium-antagonist and counteract several effects in the calcium signal transduction pathway. It can thereby attenuate premature intracellular activation of proteolytic digestive enzymes in the pancreas and thus reduce the severity of pancreatitis. Preliminary experiments have shown that magnesium (Mg2+) therapy administered as a food supplement in an animal model of acute pancreatitis has a beneficial effect on the course of the disease. We therefore hypothesise that the administration of magnesium sulphate before and after diagnostic or therapeutic endosopic retrograde cholangiopancreatography reduces the risk and severity of post-ERCP. |
| Ethics approval(s) | Ethics board at the Medical Faculty of the Ernst-Moritz-Arndt-University of Greifswald, Germany, gave approval on the 30th October 2008 (ref: BB 92/08) |
| Health condition(s) or problem(s) studied | Post-ERCP pancreatitis |
| Intervention | Magnesium arm: Intravenous application of 500 ml NaCl 0.9% containing 10 ml magnesium sulphate 50% (= 4930 mg magnesium sulphate heptahydrate; magnesium content: 486.1 mg = 20 mmol = 40 mval) 30 minutes before and 6 hours after ERCP. Duration of each intravenous infusion: 30 minutes. Placebo arm: Intravenous application of 500 ml NaCl 0.9% + 10 ml NaCl 0.9% 30 minutes before and 6 hours after ERCP. Duration of each intravenous infusion: 30 minutes. Follow up: 1. 6 and 24 hours after ERCP: blood samples, clinical examination, pain assessment, documentation of pain medication 2. If post-ERCP pancreatitis occurs: daily blood samples, clinical examination, pain assessment and documentation of pain medication until discharge from the hospital 3. 30 days after ERCP: telephone follow-up questionnaire |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Phase III |
| Drug / device / biological / vaccine name(s) | Magnesium sulphate |
| Primary outcome measure | Reduction of the incidence of post-ERCP pancreatitis by 50% |
| Secondary outcome measures | 1. Intake of analgesics 2. Duration of hospital stay in days 3. Lipase levels measured 6 and 24 hours after ERCP 4. 30-days mortality as measured with the EQ-5D-questionnaire in the telephone interview 30 days after ERCP |
| Overall study start date | 01/06/2009 |
| Completion date | 30/11/2009 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 502 patients |
| Key inclusion criteria | 1. Adult (greater than or equal to 18 years of age) patients (male and female) with a medical indication for a diagnostic or therapeutic endoscopic retrograde cholangiopancreatography (ERCP) 2. Written informed consent |
| Key exclusion criteria | 1. Known allergy or intolerance to one of the medicaments utilised in the study or their ingredients 2. Participation in another clinical study during the previous four weeks 3. Pregnancy or breast feeding 4. Acute pancreatitis 5. Renal insufficiency greater than or equal to stadium 4 (National Kidney Foundation Disease Outcomes Quality Initiative™ [NKF KDOQI™]) 6. Hyperthyroidism 7. Symptomatic bradycardia less than 35 bpm 8. Atrioventricular block greater than 1° or other cardial conduction defects 9. Myasthenia gravis 10. Liver cirrhosis Child C 11. Any apparent coagulopathy 12. Kidney stone diathesis (calcium-magnesium-ammonium-phosphate stones) 13. Mental impairment, addictive or other disorders leading to the patients inability to understand the scope and possible consequences of a participation in the clinical trial 14. Magnesium medication within 14 days before the procedure 15. Inability to give informed consent |
| Date of first enrolment | 01/06/2009 |
| Date of final enrolment | 30/11/2009 |
Locations
Countries of recruitment
- Germany
Study participating centre
Klinik für Innere Medizin A
Greifswald
17475
Germany
17475
Germany
Sponsor information
University Hospital Greifswald (Germany)
Hospital/treatment centre
Hospital/treatment centre
c/o Administrative Director Gunter Gotal
Fleischmannstrasse 8
Greifswald
17475
Germany
| Website | http://www.klinikum.uni-greifswald.de/ |
|---|---|
"ROR" |
https://ror.org/025vngs54 |
Funders
Funder type
Research council
German Research Council (Deutsche Forschungsgemeinschaft [DFG]) (Germany) (ref: SA 1994/1-1)
No information available
Ernst Moritz Arndt University of Greifswald (Ernst-Moritz-Arndt-Universität Greifswald) (Germany) - Department of Medicine A
No information available
Results and Publications
| 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 |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | protocol | 15/01/2013 | Yes | No |
