search
Back to results

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

Primary Purpose

Post-ERCP Pancreatitis

Status
Terminated
Phase
Phase 3
Locations
Germany
Study Type
Interventional
Intervention
Magnesium Sulfate
Placebo (NaCl 0,9%)
Sponsored by
University Medicine Greifswald
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Post-ERCP Pancreatitis focused on measuring MagPEP, post-ERCP pancreatitis, Magnesium Sulfate

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Klinik für Innere Medizin A, Universitätsmedizin Greifswald

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Magnesium

Placebo (NaCl 0,9%)

Arm Description

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).

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 .

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

reduction in intake of analgesics
duration of stay in hospital after ERCP
reduction in premature protease activation
reduction in severity of post-ERCP pancreatitis
reduction in 30-day morbidity

Full Information

First Posted
November 12, 2018
Last Updated
April 28, 2021
Sponsor
University Medicine Greifswald
search

1. Study Identification

Unique Protocol Identification Number
NCT03749590
Brief Title
Magnesium Sulfate in the Prevention of Post-ERCP Pancreatitis.
Acronym
MagPEP
Official Title
Prospective Randomized Controlled Phase III Trial to Investigate the Efficacy of Magnesium Sulfate in the Prevention of Post-ERCP Pancreatitis.
Study Type
Interventional

2. Study Status

Record Verification Date
April 2021
Overall Recruitment Status
Terminated
Why Stopped
The design of the MagPEP trial is no longer in compliance with the current state of science.
Study Start Date
August 27, 2012 (Actual)
Primary Completion Date
July 2020 (Actual)
Study Completion Date
August 31, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Medicine Greifswald

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post-ERCP Pancreatitis
Keywords
MagPEP, post-ERCP pancreatitis, Magnesium Sulfate

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
327 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Magnesium
Arm Type
Experimental
Arm Description
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).
Arm Title
Placebo (NaCl 0,9%)
Arm Type
Placebo Comparator
Arm Description
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 .
Intervention Type
Drug
Intervention Name(s)
Magnesium Sulfate
Other Intervention Name(s)
Magnesium Sulfate Heptahydrate
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Placebo (NaCl 0,9%)
Intervention Description
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
Primary Outcome Measure Information:
Title
reduction in the incidence of post-ERCP pancreatitis by 50 %
Time Frame
24 hours after ERCP
Secondary Outcome Measure Information:
Title
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
Title
duration of stay in hospital after ERCP
Time Frame
from end of ERCP to discharge from hospital; assessed on day 30 after ERCP
Title
reduction in premature protease activation
Time Frame
during treatment period, assessed 24 h after ERCP
Title
reduction in severity of post-ERCP pancreatitis
Time Frame
from 24 hours after ERCP onwards, assessed on day 30 after ERCP
Title
reduction in 30-day morbidity
Time Frame
30 days after ERCP

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Klinik für Innere Medizin A, Universitätsmedizin Greifswald
City
Greifswald
State/Province
Mecklenburg-Vorpommern
ZIP/Postal Code
17475
Country
Germany

12. IPD Sharing Statement

Learn more about this trial

Magnesium Sulfate in the Prevention of Post-ERCP Pancreatitis.

We'll reach out to this number within 24 hrs