Magnesium Sulfate in the Prevention of Post-ERCP Pancreatitis.

Post-ERCP Pancreatitis Clinical Trial

— MagPEP  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03749590
• Other study ID #: MagPEP
• Secondary ID: 2009-013294-18
• Status: Terminated
• Phase: Phase 3
• Start date: August 27, 2012
• Est. completion date: August 31, 2020

Study information

• Verified date: April 2021
• Source: University Medicine Greifswald
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Terminated
• Enrollment: 327
• Est. completion date: August 31, 2020
• Est. primary completion date: July 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Pancreatitis
• Post-ERCP Pancreatitis

Intervention

Drug:
• Magnesium Sulfate
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%)
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

Locations

Country	Name	City	State
Germany	Klinik für Innere Medizin A, Universitätsmedizin Greifswald	Greifswald	Mecklenburg-Vorpommern

Sponsors (1)

Lead Sponsor	Collaborator
University Medicine Greifswald

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	reduction in the incidence of post-ERCP pancreatitis by 50 %		24 hours after ERCP
Secondary	reduction in intake of analgesics		during the first 24 hours after ERCP and, if a post-ERCP pancreatitis occurs, until discharge from hospital
Secondary	duration of stay in hospital after ERCP		from end of ERCP to discharge from hospital; assessed on day 30 after ERCP
Secondary	reduction in premature protease activation		during treatment period, assessed 24 h after ERCP
Secondary	reduction in severity of post-ERCP pancreatitis		from 24 hours after ERCP onwards, assessed on day 30 after ERCP
Secondary	reduction in 30-day morbidity		30 days after ERCP