Post-ERCP pancreatitis
Conditions
Interventions
Trade Name: Magnesium Verla i.v. 50%
Product Name: magnesium sulfate
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: magnesium sulfate
Concentration unit: mg/ml milligr
Sponsors
Universitätsklinikum Greifswald der Ernst-Moritz-Arndt Universität Greifswald AöR
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Adult (= 18 years of age) patients (male and female) with a medical indication for a diagnostic or therapeutic endoscopic retrograde cholangiopancreatography (ERCP). Written informed consent. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Known allergy or intolerance to one of the medicaments utilized in the study or their ingredients Participation in another clinical study during the previous four weeks Pregnancy and breast feeding Acute pancreatitis Renal insufficiency = stadium 4 (K/DOQI) Hyperthyreoidism Symptomatic Bradycardia 1° or other cardial conduction defects Myasthenia gravis Liver cirrhosis Child C Any apparent coagulopathy Kidney stone diathesis (calcium-magnesium-ammonium-phosphate stones) Mental impairment, addicitve or other disorders leading to the patients inability to understand the scope and possible consequences of a participation in the clinical trial Magnesium medication within 14 days before the procedure Inability to give informed consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 50% reduction of the incidence of post-ERCP pancreatitis as defined in the study protocol;Secondary Objective: reduction of analgesics use reduction of length of hospital stay reduction of procedure-related morbidity;Primary end point(s): Reduction of the incidence of post-ERCP pancreatitis by 50% | — |
Countries
Germany, Hungary
Outcome results
None listed