Condition category
Digestive System
Date applied
01/03/2009
Date assigned
07/04/2009
Last edited
12/02/2013
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

http://www.pancreas.de/

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

http://www.klinikum.uni-greifswald.de/

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

  1. 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.

Additional files

Editorial Notes