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FLUYT-trial


- candidate number22319
- NTR NumberNTR5166
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR8-jun-2015
- Secondary IDsISRCTN13659155 ABR NL52341.100.15
- Public TitleFLUYT-trial
- Scientific TitleThe FLUYT-prevent study: Fluid Hydration to prevent post-endoscopic retrograde cholangiopancreatography Pancreatitis
- ACRONYMFLUYT
- hypothesisPeri-procedural intensive RL hydration on top of RN will reduce the incidence of PEP in a moderate-high risk population, and may even reduce the percentage of severe PEP. This may improve patientsí health status, prevent serious complications of PEP, reduce the demand for healthcare, and will lower costs. We hypothesize that this peri-procedural intensive RL hydration therapy is superior to usual care with respect to patient outcomes (PEP).
- Healt Condition(s) or Problem(s) studiedEndoscopic retrograde cholangiopancreatography (ERCP), Pancreatitis, Prevention, Fluid therapy
- Inclusion criteria1) Age 18-85
2) Indication for ERCP
3) Written Informed Consent
- Exclusion criteria1) Allergy to NSAIDís or other contraindications
2) Ongoing acute pancreatitis
3) Ongoing hypotension, including those with sepsis
4) Cardiac insufficiency (>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 or pancreatic head mass or routine biliary stent exchange; reERCP with a history of endoscopic sphincterotomy with a CBD intervention (PD intervention is allowed)
14) Planned prophylactic pancreatic stent placement
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingNone
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 5-jun-2015
- planned closingdate5-jan-2016
- Target number of participants826
- InterventionsIntervention: Ringer's lactated solution
Control: NaCl 0.9%
- Primary outcomePost-ERCP pancreatitis (Cotton criteria)
- Secondary outcome1) Severity of PEP (according to the Cotton classification)
2) Severe morbidity (according to the revised Atlanta criteria) and mortality.
3) ERCP-procedure related complications: bleeding, perforation, post-ERCP fever/ cholangitis/ cholecystitis
4) Ringer's lactated solution hydration related complications, especially: pulmonary edema, cardiac insufficiency, peripheral edema,hypernatremia and renal failure. All adverse events will be monitored, according to good clinical practice (GCP). 5) Length of hospital and intensive care unit (ICU) stay.
6) Direct (non)medical costs, indirect costs, among others by using iMTA PCQ questionnaire
7) Generic health related quality of life measured with the EQ5D and the SF36
8) Risk-factors for PEP development: pre-ERCP BUN levels, validation of already known risk factors, BMI, smoking behavior, co-morbidity (diabetes, cardiovascular disease, ect.), sedation type (midazolam, propofol, fentanyl), social/ economic status, race.
9) Exocrine and endocrine pancreatic insufficiency at 180 days in patients who had developed PEP: fecal elastase-1 <200 žg/L, HbA1c >42 mmol/mol.
10) Incidence of delayed PEP (PEP >48h after the procedure).
- Timepoints1) Patient-related quality of life: at 30, 90 and 180 days
2) Exocrin and endocrin pancreatic insufficiency at 180 days
- Trial web sitewww.fluyt-trial.nl
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIESDr Xavier Smeets
- CONTACT for SCIENTIFIC QUERIESDr. E.J.M. van Geenen
- Sponsor/Initiator Radboud University Medical Center Nijmegen
- Funding
(Source(s) of Monetary or Material Support)
ZON-MW, The Netherlands Organization for Health Research and Development
- Publications
- Brief summary
- Main changes (audit trail)
- RECORD8-jun-2015 - 19-jun-2015


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