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

Study website

Contact information

Prof Markus Lerch
Scientific

Klinik für Innere Medizin A
Klinikum der Ernst-Moritz-Arndt-Universität
Friedrich-Loeffler-Str. 23A
Greifswald
17475
Germany

Phone +49 (0)3834 867230
Email lerch@uni-greifswald.de

Study information

Study designProspective randomised double-blind placebo-controlled multicentre study
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Participant information sheet Can be found at http://www.pancreas.de (German only)
Scientific titleMagnesium sulphate in the prevention of Post-ERCP Pancreatitis: a prospective randomised, placebo-controlled multicentre study
Study acronymMagPEP
Study objectivesAcute 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) studiedPost-ERCP pancreatitis
InterventionMagnesium 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 typeDrug
Pharmaceutical study type(s)
PhasePhase III
Drug / device / biological / vaccine name(s)Magnesium sulphate
Primary outcome measureReduction of the incidence of post-ERCP pancreatitis by 50%
Secondary outcome measures1. 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 date01/06/2009
Completion date30/11/2009

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexBoth
Target number of participants502 patients
Key inclusion criteria1. 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 criteria1. 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 enrolment01/06/2009
Date of final enrolment30/11/2009

Locations

Countries of recruitment

  • Germany

Study participating centre

Klinik für Innere Medizin A
Greifswald
17475
Germany

Sponsor information

University Hospital Greifswald (Germany)
Hospital/treatment centre

c/o Administrative Director Gunter Gotal
Fleischmannstrasse 8
Greifswald
17475
Germany

Website http://www.klinikum.uni-greifswald.de/
ROR logo "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 shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot 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