FLUYT-prevent trial

Fluid hydration to prevent post-endoscopic retrograde cholangiopancreatography pancreatitis

Registry ID
ISRCTN13659155
Source registry
ISRCTN
Status
No longer recruiting
Study type
INTERVENTIONAL
Sponsor
Radboud University Medical Center
Enrollment
826
Start date
2015-06-05
Completion date
2019-12-03
Last update
2026-08-17

Conditions

Summary

Choledocholithiasis and other conditions requiring endoscopic retrograde cholangiopancreatography (ERCP)

Detailed description

High volume intravenous hydration with lactated Ringer's solution Added 17/02/2017: Partcipants are randomised to one of two treatment arms: 1. Control group: 100mg rectal NSAID + no or mild hydration with normal saline (max 1.5mL/kg/hr, max. 3L/24h) 2. Intervention group: 100mg rectal NSAID + hydration with lactated Ringer’s solution (20mL/kg <60min, starting at the beginning of ERCP (scope-mouth contact), followed by 3mL/kg/hr for 8 hours) Patients are discharged after ERCP after a minimal clinical stay of 24 hours. It is at the discretion of the treating physician whether an admission or longer monitoring is indicated. All patients are followed up for 180 days after randomization.

Interventions

Inclusion criteria

1. Requiring ERCP 2. Between 18 and 85 years of age 3. Signed informed consent

Exclusion criteria

1. Allergy to NSAIDs or other contraindications 2. Ongoing acute pancreatitis 3. Ongoing hypotension, including those with sepsis 4. Cardiac insufficiency (CI, >NYHA Class I 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) 11. Hypernatremia (Na+ levels > 150mmol/l) 12. Oedema 13. Low risk of PEP: chronic calcific pancreatitis (PD intervention is allowed) or pancreatic head mass or routine biliary stent exchange or re-ERCP with a history of endoscopicsphincterotomy with a CBD intervention (PD intervention is allowed)

Locations

Related clinical trials

View on source registry