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MagPEP: Magnesium Sulfate in the Prevention of Post-ERCP Pancreatitis.

Sponsor
University Medicine Greifswald (Other)
Overall Status
Terminated
CT.gov ID
NCT03749590
Collaborator
(none)
327
Enrollment
1
Location
2
Arms
96.1
Actual Duration (Months)
3.4
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Magnesium Sulfate
  • Drug: Placebo (NaCl 0,9%)
 Phase 3

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
327 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose:
Prevention
Official Title:
Prospective Randomized Controlled Phase III Trial to Investigate the Efficacy of Magnesium Sulfate in the Prevention of Post-ERCP Pancreatitis.
Actual Study Start Date :
Aug 27, 2012
Actual Primary Completion Date :
Jul 1, 2020
Actual Study Completion Date :
Aug 31, 2020

Arms and Interventions

Arm Intervention/Treatment
Experimental: Magnesium

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
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
Other Names:
  • Magnesium Sulfate Heptahydrate

    		•
    Placebo Comparator: 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 .

    Drug: 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

    Outcome Measures

    Primary Outcome Measures

    1. reduction in the incidence of post-ERCP pancreatitis by 50 % [24 hours after ERCP]

    Secondary Outcome Measures

    1. reduction in intake of analgesics [during the first 24 hours after ERCP and, if a post-ERCP pancreatitis occurs, until discharge from hospital]

    2. duration of stay in hospital after ERCP [from end of ERCP to discharge from hospital; assessed on day 30 after ERCP]

    3. reduction in premature protease activation [during treatment period, assessed 24 h after ERCP]

    4. reduction in severity of post-ERCP pancreatitis [from 24 hours after ERCP onwards, assessed on day 30 after ERCP]

    5. reduction in 30-day morbidity [30 days after ERCP]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Klinik für Innere Medizin A, Universitätsmedizin Greifswald Greifswald Mecklenburg-Vorpommern Germany 17475

    Sponsors and Collaborators

    • University Medicine Greifswald

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University Medicine Greifswald
    ClinicalTrials.gov Identifier:
    NCT03749590
    Other Study ID Numbers:
    • MagPEP
    • 2009-013294-18
    First Posted:
    Nov 21, 2018
    Last Update Posted:
    May 3, 2021
    Last Verified:
    Apr 1, 2021
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by University Medicine Greifswald
    MagPEP, post-ERCP pancreatitis, Magnesium Sulfate
    Additional relevant MeSH terms:
    Pancreatitis
    Magnesium Sulfate

    Study Results

    No Results Posted as of May 3, 2021