Magnesium Sulfate in the Prevention of Post-ERCP Pancreatitis.

NCT03749590 | Terminated Phase 3

• 2 other identifiers: MagPEP2009-013294-18
• Study Type: interventional
• Target: 327
• Locations: 1 country
• Sites: 1

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.

Conditions

Post-ERCP Pancreatitis

Keywords

MagPEP, post-ERCP pancreatitis, Magnesium Sulfate

Outcome Measures

Primary Outcomes (1)

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

  24 hours after ERCP

Secondary Outcomes (5)

• 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

Study Arms (2)

Magnesium

EXPERIMENTAL

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

Placebo (NaCl 0,9%)

PLACEBO COMPARATOR

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%)

Interventions

Magnesium Sulfate DRUG

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

Also known as: Magnesium Sulfate Heptahydrate

Magnesium

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

Placebo (NaCl 0,9%)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• medical indication for ERCP
• first ERCP in the Patient
• signed informed consent forms for ERCP and MagPEP trial

You may not qualify if:

• 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)

Sponsors & Collaborators

• University Medicine Greifswald: lead

Study Sites (1)

Klinik für Innere Medizin A, Universitätsmedizin Greifswald

Greifswald, Mecklenburg-Vorpommern, 17475, Germany

Location

MeSH Terms

Interventions

Magnesium Sulfate

Intervention Hierarchy (Ancestors)

Magnesium Compounds; Inorganic Chemicals; Sulfates; Sulfuric Acids; Sulfur Acids; Sulfur Compounds

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 12, 2018
• First Posted: November 21, 2018
• Study Start: August 27, 2012
• Primary Completion: July 1, 2020
• Study Completion: August 31, 2020
• Last Updated: May 3, 2021

Record last verified: 2021-04

Locations

DE (1)