Clinical trial NCT03749590: Magnesium Sulfate in the Prevention of Post-ERCP Pancreatitis.
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
Overall status: TERMINATED
Phase: PHASE3
Conditions: Post-ERCP Pancreatitis
Keywords: MagPEP, post-ERCP pancreatitis, Magnesium Sulfate
Lead sponsor: University Medicine Greifswald
Sponsor class: OTHER
First posted: 2018-11-21
Enrollment: 327
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: reduction in the incidence of post-ERCP pancreatitis by 50 %
timeFrame: 24 hours after ERCP
Secondary outcomes:
measure: reduction in intake of analgesics
timeFrame: during the first 24 hours after ERCP and, if a post-ERCP pancreatitis occurs, until discharge from hospital
measure: duration of stay in hospital after ERCP
timeFrame: from end of ERCP to discharge from hospital; assessed on day 30 after ERCP
measure: reduction in premature protease activation
timeFrame: during treatment period, assessed 24 h after ERCP
measure: reduction in severity of post-ERCP pancreatitis
timeFrame: from 24 hours after ERCP onwards, assessed on day 30 after ERCP
measure: reduction in 30-day morbidity
timeFrame: 30 days after ERCP
Other outcomes:
Locations:
city: Greifswald
country: Germany
facility: Klinik für Innere Medizin A, Universitätsmedizin Greifswald
state: Mecklenburg-Vorpommern
Study officials:
References: