Magnesium Sulfate in the Prevention of Post-ERCP Pancreatitis.

• Status: Terminated
• Trial end date: 2020-08-31
• Target enrollment: 0
• Participant gender: All

Summary

MagPEP is a multi-centre, randomized, phase III, double blind, placebo controlled, parallel group trial. It evaluates magnesium sulfate for the prevention of post-ERCP pancreatitis. Adult patients with a medical indication for ERCP are to be randomized (1:1 ratio) to receive either magnesium sulfate or placebo (NaCl 0,9%) 60 min before and 6 hours after ERCP.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Medicine Greifswald
• Treatments: Magnesium Sulfate

Criteria

Inclusion Criteria:

• medical indication for ERCP

• first ERCP in the Patient

• signed informed consent forms for ERCP and MagPEP trial

Exclusion Criteria:

• privious ERCP

• hypersensitivity to study medication or similar substances

• participation in another clinical trial during the last 4 weeks

• addictive disorders

• women who are pregnant or breastfeeding

• unwillingness or inability to comply with study protocol

• acute pancreatitis

• renal insufficiency of stage 4 or higher

• active hyperthyreosis

• symptomatic bradycardia (<35/min)

• known history of Myasthenia gravis

• AV bock > first degree or other bradycardic disorders of conductivity

• liver cirrhosis Child C

• coagulation disorder

• urinary stone diathesis (calcium magnesium ammonium phosphate stones)

• patients who are not able to provide informed consent

• intake of magnesium during the last 14 days

• intake of calcium antagonists