Magnesium Sulfate in the Prevention of Post-ERCP Pancreatitis.

Phase 3TerminatedNCT03749590

University Medicine Greifswald327 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

TRIPLE

Enrollment

327

Conditions

Post-ERCP Pancreatitis

Interventions

Magnesium SulfateDRUG

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

Placebo (NaCl 0,9%)DRUG

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Klinik für Innere Medizin A, Universitätsmedizin Greifswald

Greifswald, Mecklenburg-Vorpommern, Germany

Outcomes

Primary Outcomes

reduction in the incidence of post-ERCP pancreatitis by 50 %

Time frame: 24 hours after ERCP

Secondary Outcomes

reduction in intake of analgesics

Time frame: 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

Time frame: from end of ERCP to discharge from hospital; assessed on day 30 after ERCP

reduction in premature protease activation

Time frame: during treatment period, assessed 24 h after ERCP

reduction in severity of post-ERCP pancreatitis

Time frame: from 24 hours after ERCP onwards, assessed on day 30 after ERCP

reduction in 30-day morbidity

Time frame: 30 days after ERCP

Data from ClinicalTrials.gov

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