EUCTR2015-000829-37-NL
Active, not recruiting
Phase 1
Fluid hydration to prevent post-endoscopic retrograde cholangiopancreatography (ERCP) pancreatitis: the FLUYT-prevent trial. a multicenter randomized controlled superiority trial. - FLUYT-prevent trial
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Patients with choledocholithiasis
- Sponsor
- Radboud University Medical Center
- Enrollment
- 826
- Status
- Active, not recruiting
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Age between 17 and 86
- •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 750
- •F.1\.3 Elderly (\>\=65 years) yes
- •F.1\.3\.1 Number of subjects for this age range 76
Exclusion Criteria
- •1\) Allergy to NSAID’s or other contraindications
- •2\) Ongoing acute pancreatitis
- •3\) Ongoing hypotension, including those with sepsis
- •4\) Cardiac insufficiency (CI, \>NYHA Class II heart failure)
- •5\) Renal insufficiency (RI, creatinin clearance \<40ml/min)
- •6\) Active ulcer disease
- •7\) Severe liver dysfunction: Liver cirrhosis and ascites
- •8\) Respiratory insufficiency (pO2\<60mmHg or 90% despite FiO2 of 30% or requiring mechanical ventilation).
- •9\) Pregnancy
- •10\) Hyponatremia (Na\+ levels \< 130mmol/l)
Outcomes
Primary Outcomes
Not specified
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