Magnesium Sulfate in the Prevention of Post-ERCP Pancreatitis.

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Prospective Randomized Controlled Phase III Trial to Investigate the Efficacy of Magnesium Sulfate in the Prevention of Post-ERCP Pancreatitis.

Conditions
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Post-ERCP Pancreatitis

Intervention / Treatment
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* Drug: Magnesium Sulfate
* Drug: Placebo (NaCl 0,9%)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Magnesium<br>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). | Drug: Magnesium Sulfate<br>* Patients receive 2 infusions (10 ml magnesium sulfate added to 500 ml NaCl 0.9%): the first infusion 60 min before and the second one 6 hours after ERCP<br>* Other names: Magnesium Sulfate Heptahydrate;|
| Placebo Comparator: Placebo (NaCl 0,9%)<br>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 . | Drug: Placebo (NaCl 0,9%)<br>* Patients receive 2 infusions (10 ml NaCl 0.9% added to 500 ml NaCl 0.9%): the first infusion 60 min before and the second one 6 hours after ERCP<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| reduction in the incidence of post-ERCP pancreatitis by 50 % |  | 24 hours after ERCP | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| reduction in intake of analgesics |  | during the first 24 hours after ERCP and, if a post-ERCP pancreatitis occurs, until discharge from hospital | 
| duration of stay in hospital after ERCP |  | from end of ERCP to discharge from hospital; assessed on day 30 after ERCP | 
| reduction in premature protease activation |  | during treatment period, assessed 24 h after ERCP | 
| reduction in severity of post-ERCP pancreatitis |  | from 24 hours after ERCP onwards, assessed on day 30 after ERCP | 
| reduction in 30-day morbidity |  | 30 days after ERCP | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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MagPEP, post-ERCP pancreatitis, Magnesium Sulfate