Magnesium Sulfate in the Prevention of Post-ERCP Pancreatitis.
- Conditions
- Post-ERCP Pancreatitis
- Interventions
- Drug: Placebo (NaCl 0,9%)
- Registration Number
- NCT03749590
- Lead Sponsor
- University Medicine Greifswald
- Brief 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.
- Detailed 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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 327
- medical indication for ERCP
- first ERCP in the Patient
- signed informed consent forms for ERCP and MagPEP trial
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo (NaCl 0,9%) Placebo (NaCl 0,9%) 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 . Magnesium Magnesium Sulfate 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).
- Primary Outcome Measures
Name Time Method reduction in the incidence of post-ERCP pancreatitis by 50 % 24 hours after ERCP
- Secondary Outcome Measures
Name Time Method 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 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
Trial Locations
- Locations (1)
Klinik für Innere Medizin A, Universitätsmedizin Greifswald
🇩🇪Greifswald, Mecklenburg-Vorpommern, Germany