Does prophylactic administration of magnesium reduce the risk and severity of post-endoscopic retrograde cholangiopancreatography (post-ERCP) pancreatitis? A clinical study.

Magnesium sulphate in the prevention of Post-ERCP Pancreatitis: a prospective randomised, placebo-controlled multicentre study

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN46556454

Enrollment

502

Registered

2009-04-07

Start date

2009-06-01

Completion date

Unknown

Last updated

2015-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Post-ERCP pancreatitis Digestive System Acute pancreatitis

Interventions

Magnesium arm: Intravenous application of 500 ml NaCl 0.9% containing 10 ml magnesium sulphate 50% (= 4930 mg magnesium sulphate heptahydrate

magnesium content: 486.1 mg = 20 mmol = 40 mval) 30 minutes before and 6 hours after ERCP. Duration of each intravenous infusion: 30 minutes. Placebo arm: Intravenous application of 500 ml NaCl 0.9

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Adult (greater than or equal to 18 years of age) patients (male and female) with a medical indication for a diagnostic or therapeutic endoscopic retrograde cholangiopancreatography (ERCP) 2. Written informed consent

Exclusion criteria

Exclusion criteria: 1. Known allergy or intolerance to one of the medicaments utilised in the study or their ingredients 2. Participation in another clinical study during the previous four weeks 3. Pregnancy or breast feeding 4. Acute pancreatitis 5. Renal insufficiency greater than or equal to stadium 4 (National Kidney Foundation Disease Outcomes Quality Initiative™ [NKF KDOQI™]) 6. Hyperthyroidism 7. Symptomatic bradycardia less than 35 bpm 8. Atrioventricular block greater than 1° or other cardial conduction defects 9. Myasthenia gravis 10. Liver cirrhosis Child C 11. Any apparent coagulopathy 12. Kidney stone diathesis (calcium-magnesium-ammonium-phosphate stones) 13. Mental impairment, addictive or other disorders leading to the patients inability to understand the scope and possible consequences of a participation in the clinical trial 14. Magnesium medication within 14 days before the procedure 15. Inability to give informed consent

Design outcomes

Primary

Measure	Time frame
Reduction of the incidence of post-ERCP pancreatitis by 50%	—

Secondary

Measure	Time frame
1. Intake of analgesics 2. Duration of hospital stay in days 3. Lipase levels measured 6 and 24 hours after ERCP 4. 30-days mortality as measured with the EQ-5D-questionnaire in the telephone interview 30 days after ERCP	—

Countries

Germany

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Mar 24, 2026