Magnesium Sulfate in the Prevention of Post-ERCP Pancreatitis. (MagPEP)

University Medicine Greifswald

Status and phase: Terminated; Phase 3

Conditions: Post-ERCP Pancreatitis

Treatments: Drug: Placebo (NaCl 0,9%); Drug: Magnesium Sulfate

Study type: Interventional

Funder types: Other

Identifiers

NCT03749590

MagPEP

2009-013294-18 (EudraCT Number)

Details and patient eligibility

About

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.

Full description

Title: prospective, randomized, placebo controlled, phase III trial to evaluate the efficacy of magnesium sulfate for the prevention of post-ERCP pancreatitis

Study drug: Magnesium sulfate

Indication: post-ERCP pancreatitis

Study design: multi-centre, randomized, phase III, double blind, placebo controlled, parallel group

Patient population: adult patients with a medical indication for ERCP

Number of patients: 1376 randomized to two equal groups

Treatment: patients receive 2 infusions of 500 ml NaCl 0,9%: the first one 60 min before ERCP and the second one 6 hours after ERCP. To the infusions 10 ml of either magnesium sulfate or placebo (NaCl 0,9%) will be added.

Enrollment: 327 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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327 participants in 2 patient groups, including a placebo group

Magnesium

Experimental group

Description:

Patients receive 2 infusions of 500 ml NaCl 0,9%: the first one 60 min before ERCP and the second one 6 hours after ERCP. With each infusion 10 ml magnesium sulfate (4930 mg magnesium sulfate = 20 mmol magnesium) are administered (total dose: 9860 mg magnesium sulfate).

Treatment:

Drug: Magnesium Sulfate

Placebo (NaCl 0,9%)

Placebo Comparator group

Description:

Patients receive 2 infusions of 500 ml NaCl 0,9%: the first one 60 min before ERCP and the second one 6 hours after ERCP. To each infusion 10 ml NaCl 0.9% (Placebo) will be added .

Treatment:

Drug: Placebo (NaCl 0,9%)