Magnesium Sulfate in the Prevention of Post-ERCP Pancreatitis.

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

327 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-08-27

Study Completion Date

2020-08-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Post-ERCP Pancreatitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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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).

Group Type EXPERIMENTAL

Magnesium Sulfate

Intervention Type 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

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 .

Group Type PLACEBO_COMPARATOR

Placebo (NaCl 0,9%)

Intervention Type 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

Interventions

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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

Intervention Type 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

Intervention Type DRUG

Other Intervention Names

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Magnesium Sulfate Heptahydrate

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No