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    The EU Clinical Trials Register currently displays   43865   clinical trials with a EudraCT protocol, of which   7286   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

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    Summary
    EudraCT Number:2015-000829-37
    Sponsor's Protocol Code Number:NL52341.100.15
    National Competent Authority:Netherlands - Competent Authority
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2015-04-21
    Trial results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedNetherlands - Competent Authority
    A.2EudraCT number2015-000829-37
    A.3Full title of the trial
    Fluid hydration to prevent post-endoscopic retrograde cholangiopancreatography (ERCP) pancreatitis: the FLUYT-prevent trial. a multicenter randomized controlled superiority trial.
    Intraveneuze vochttoediening ter preventie van post-endoscopische retrograde cholangiopancreatografie (ERCP) pancreatitis: de FLUYTprevent studie. een multicenter gerandomiseerd, gecontroleerde superioriteits trial.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    intravenous fluid administration to prevent pancreatic inflammation following endoscopic bile duct examination.
    intraveneuze vochttoediening om alvleesklierontsteking te voorkomen na endoscopisch galwegonderzoek.
    A.3.2Name or abbreviated title of the trial where available
    FLUYT-prevent trial
    FLUYT-prevent trial
    A.4.1Sponsor's protocol code numberNL52341.100.15
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorRadboud University Medical Center
    B.1.3.4CountryNetherlands
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportDepartment of Gastroenterology, Radboud University Medical Center
    B.4.2CountryNetherlands
    B.4.1Name of organisation providing supportZonMw
    B.4.2CountryNetherlands
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationDutch Pancreatitis Study Group
    B.5.2Functional name of contact pointwww.pancreatitis.nl
    B.5.3 Address:
    B.5.3.1Street AddressKoekoekslaan 1
    B.5.3.2Town/ cityNieuwegein
    B.5.3.3Post code3430 EM
    B.5.3.4CountryNetherlands
    B.5.6E-mailx.smeets@pancreatitis.nl
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name Ringerlactaat, oplossing voor infusie
    D.2.1.1.2Name of the Marketing Authorisation holder Baxter B.V. Kobaltweg 49 3542 CE UTRECHT
    D.2.1.2Country which granted the Marketing AuthorisationNetherlands
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameRingerlactaat, oplossing voor infusie
    D.3.4Pharmaceutical form Solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous drip use (Noncurrent)
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INN0,9% NaCl solution
    D.3.9.2Current sponsor codeSaline
    D.3.9.3Other descriptive nameSALINE
    D.3.9.4EV Substance CodeSUB20722
    D.3.10 Strength
    D.3.10.1Concentration unit g/l gram(s)/litre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number9
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNRINGER'S LACTATE SOLUTION
    D.3.9.1CAS number 8026-79-7
    D.3.9.2Current sponsor codeRL
    D.3.9.3Other descriptive nameRINGER'S LACTATE SOLUTION
    D.3.9.4EV Substance CodeSUB33298
    D.3.10 Strength
    D.3.10.1Concentration unit mmol/l millimole(s)/litre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number278
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 2
    D.1.2 and D.1.3IMP RoleComparator
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name Natriumchloride 0,9%, oplossing voor intraveneuze infusie
    D.2.1.1.2Name of the Marketing Authorisation holderB. Braun Avitum AG Schwarzenberger Weg 73-79 D-34212 MELSUNGEN (DUITSLAND)
    D.2.1.2Country which granted the Marketing AuthorisationNetherlands
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameNatriumchloride 0,9%, oplossing voor intraveneuze infusie
    D.3.4Pharmaceutical form Solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous drip use (Noncurrent)
    Auricular use
    Intravenous use
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Patients with choledocholithiasis
    Patienten met choledocholithiasis
    E.1.1.1Medical condition in easily understood language
    Patients in whom gallstones have migrated from the gallbladder and become stuck in the lower biliary tract.
    Patienten bij wie galstenen vanuit de galblaas klem zijn komen te zitten in de lagere galwegen.
    E.1.1.2Therapeutic area Diseases [C] - Digestive System Diseases [C06]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To investigate whether administration of large volumes of intravenous ringer's lactated solution, on top of rectal NSAID's, can reduce the risk of post-ERCP pancreatitis (PEP), as compared with current practice of administration of only rectal NSAID's and no or small amount of saline solution.
    Het onderzoeken of de intraveneuze toediening van ruime hoeveelheden ringer's lactaat oplossing, bovenop rectale NSAID's, het risico op post-ERCP pancreatitis (PEP) kan verminderen ten opzichte van de huidige standaard van alleen een rectale NSAID met geen tot weinig zoutoplossing via het infuus.
    E.2.2Secondary objectives of the trial
    To investigate between the two groups 1) severity of PEP (mild, moderate, severe), 2) severe morbidity or mortality, 3) ERCP related complications, 4) complications of intravenous hydration, 5) length of hospital stay (including ICU), 6) differences in costs, 7) quality of life scores.
    Onderzoeken of er tussen de twee behandelgroepen verschillen zijn in 1) PEP ernst (mild, matig, ernstig), 2) ernstige morbiditeit of mortaliteit, 3) ERCP gerelateerde complicaties, 4) complicaties ten gevolge van intraveneuze vochttoediening, 5) ziekenhuisopnameduur (inclusief ICU opname), 6) verschillen in kosten, 7) kwaliteit van leven scores.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Age between 17 and 86
    written informed consent
    leeftijd tussen 17 en 86
    getekende toestemmingsverklaring
    E.4Principal 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)
    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; re-ERCP with a history of endoscopic sphincterotomy with a CBD intervention (PD intervention is allowed)
    14) Planned prophylactic pancreatic stent placement
    1) NSAID allergie
    2) reeds bestaande acute pancreatitis
    3) reeds bestaande hypotensie
    4) Hartfalen (>NYHA Class II heart failure)
    5) Nierfalen (kreatinine klaring <40ml/min)
    6) Ulcuslijden
    7) Ernstige leverstoornissen
    8)longfalen (beademingsbehoeftig)
    9) zwangerschap
    10) Hyponatremie (Na+ levels < 130mmol/l)
    11) Hypernatremie (Na+ levels > 150mmol/l)
    12) Oedeem
    13) laag risico op PEP (chronische pancreatitis, pancreaskopmassa, galwegstentwissel)
    14) geplande pancreasstentplaatsing
    E.5 End points
    E.5.1Primary end point(s)
    Post-ERCP pancreatitis
    post-ERCP pancreatitis
    E.5.1.1Timepoint(s) of evaluation of this end point
    48 hours after ERCP
    48 uur na ERCP
    E.5.2Secondary end point(s)
    1) severity of PEP (mild, moderate, severe), 2) severe morbidity or death, 3) ERCP related complications (eg bleeding, perforation) 4) fluid administration related complications (pulmonary or peripheral edema, hypernatremia), 5) length of stay, 6) costs (direct and indirect), 7) Quality of life scores.
    1) ernst van PEP (mild, matig, ernstig), 2) ernstige morbiditeit of overlijden, 3) ERCP gerelateerde complicaties, 4) vochtgerelateerde complicaties (overvulling, oedeem, hypernatriemie), 5) ziekenhuisopnameduur, 6) directe en indirecte kosten, 7) kwaliteit van leven scores.
    E.5.2.1Timepoint(s) of evaluation of this end point
    varies between endpoints
    verschilt per eind punt
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis Yes
    E.6.3Therapy Yes
    E.6.4Safety No
    E.6.5Efficacy No
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) Yes
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Yes
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    0,9% NaCl oplossing
    0,9% Saline solution
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned11
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.7Trial has a data monitoring committee Yes
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    6 months after inclusion of the last patient
    6 maanden na inclusie van laatste patient
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 750
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 76
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state826
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    None
    geen
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2015-05-06
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-04-14
    P. End of Trial
    P.End of Trial StatusOngoing
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
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