Contact information
Type
Scientific
Primary contact
Prof Markus Lerch
ORCID ID
Contact details
Klinik für Innere Medizin A
Klinikum der Ernst-Moritz-Arndt-Universität
Friedrich-Loeffler-Str. 23A
Greifswald
17475
Germany
+49 (0)3834 867230
lerch@uni-greifswald.de
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Magnesium sulphate in the prevention of Post-ERCP Pancreatitis: a prospective randomised, placebo-controlled multicentre study
Acronym
MagPEP
Study hypothesis
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
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)
Study design
Prospective randomised double-blind placebo-controlled multicentre study
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Can be found at http://www.pancreas.de (German only)
Condition
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
Phase
Phase III
Drug names
Magnesium sulphate
Primary outcome measures
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 trial start date
01/06/2009
Overall trial end date
30/11/2009
Reason abandoned
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
502 patients
Participant 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
Recruitment start date
01/06/2009
Recruitment end date
30/11/2009
Locations
Countries of recruitment
Germany
Trial participating centre
Klinik für Innere Medizin A
Greifswald
17475
Germany
Sponsor information
Organisation
University Hospital Greifswald (Germany)
Sponsor details
c/o Administrative Director Gunter Gotal
Fleischmannstrasse 8
Greifswald
17475
Germany
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Research council
Funder name
German Research Council (Deutsche Forschungsgemeinschaft [DFG]) (Germany) (ref: SA 1994/1-1)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Ernst Moritz Arndt University of Greifswald (Ernst-Moritz-Arndt-Universität Greifswald) (Germany) - Department of Medicine A
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
Results - basic reporting
Publication summary
1. 2013 protocol in http://www.ncbi.nlm.nih.gov/pubmed/23320650
Publication citations
-
Protocol
Fluhr G, Mayerle J, Weber E, Aghdassi A, Simon P, Gress T, Seufferlein T, Mössner J, Stallmach A, Rösch T, Müller M, Siegmund B, Büchner-Steudel P, Zuber-Jerger I, Kantowski M, Hoffmeister A, Rosendahl J, Linhart T, Maul J, Czakó L, Hegyi P, Kraft M, Engel G, Kohlmann T, Glitsch A, Pickartz T, Budde C, Nitsche C, Storck K, Lerch MM, Pre-study protocol MagPEP: a multicentre randomized controlled trial of magnesium sulphate in the prevention of post-ERCP pancreatitis., BMC Gastroenterol, 2013, 13, 11, doi: 10.1186/1471-230X-13-11.