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    Summary
    EudraCT Number:2020-005412-21
    Sponsor's Protocol Code Number:DOBU-Whipple
    National Competent Authority:Belgium - FPS Health-DGM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2021-02-23
    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 ConcernedBelgium - FPS Health-DGM
    A.2EudraCT number2020-005412-21
    A.3Full title of the trial
    Effect of dobutamine on hepatic blood flow during goal-directed hemodynamic therapy.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Effect of dobutamine on hepatic blood flow during goal-directed hemodynamic therapy.
    A.4.1Sponsor's protocol code numberDOBU-Whipple
    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 SponsorUZ Gent
    B.1.3.4CountryBelgium
    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 supportGhent University Hospital
    B.4.2CountryBelgium
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationGhent University Hospital
    B.5.2Functional name of contact pointHiruz CTU
    B.5.3 Address:
    B.5.3.1Street AddressCorneel Heymanslaan 10
    B.5.3.2Town/ cityGhent
    B.5.3.3Post code9000
    B.5.3.4CountryBelgium
    B.5.4Telephone number3293320500
    B.5.5Fax number3293320520
    B.5.6E-mailhiruz.ctu@uzgent.be
    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 Dobutamine EG 250 mg/20 ml concentraat voor oplossing voor infusie.
    D.2.1.1.2Name of the Marketing Authorisation holderEurogenerics NV
    D.2.1.2Country which granted the Marketing AuthorisationBelgium
    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.3.4Pharmaceutical form Concentrate for solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNDOBUTAMINE
    D.3.9.1CAS number 34368-04-2
    D.3.9.4EV Substance CodeSUB06343MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number12.5
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNSODIUM METABISULFITE
    D.3.9.3Other descriptive nameSODIUM METABISULFITE
    D.3.9.4EV Substance CodeSUB12299MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.2
    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
    Evaluating hepatic blood flow and caval & portal vein pressures during goal-directed hemodynamic therapy in patients undergoing pancreaticoduodenectomy.
    E.1.1.1Medical condition in easily understood language
    hepatic blood flow
    caval & portal vein pressures
    E.1.1.2Therapeutic area Body processes [G] - Circulatory and Respiratory Physiological Phenomena [G09]
    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 assess the effect of dobutamine on hepatic blood flow and caval & portal vein pressures during goal-directed hemodynamic therapy in patients undergoing pancreaticoduodenectomy.
    E.2.2Secondary objectives of the trial
    To assess the effects of dobutamine on systemic hemodynamics (CI, HR, SAP, DAP, MAP, CVP, SVV, PPV), systemic vascular resistance (SVR), SVRI, dPmx and portal venous resistance (PVR), cardiac index (CI), during goal-directed hemodynamic therapy in patients undergoing pancreaticoduodenectomy.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Adult ≥ 18 years ≤ 80 years (female or male).
    • ASA I – II – III.
    • Able to comprehend, sign and date the written informed consent document to participate in the clinical trial.
    • Patient is scheduled for pancreaticoduodenectomy (Whipple`s procedure).
    E.4Principal exclusion criteria
    • Allergy to the medication dobutamine.
    • Renal insufficiency (SCr > 2 mg/dL).
    • Severe heart failure (EF < 25%).
    • Hemodynamic unstable patients.
    • Atrial fibrillation.
    • Sinustachycardia > 100 bpm on pre-operative electrocardiogram.
    • Sepsis.
    • BMI > 40.
    • Severe coagulopathy (INR > 2).
    • Thrombocytopenia (< 80 x 103 /mcL).
    • End stage liver disease and/or portal hypertension.
    • Pregnancy and breastfeeding women.
    E.5 End points
    E.5.1Primary end point(s)
    Changes in portal and arterial HBF during goal-directed hemodynamic therapy.
    Changes in portal vein and caval vein pressures before and after dobutamine infusion.
    E.5.1.1Timepoint(s) of evaluation of this end point
    T1 - baseline measurements without inotropic support
    T2 - Dobutamine infusion at 2 mcg/kg/min
    T3 - After minimum 10 minutes, infusion will be set at 5 mcg/kg/min
    T4 - final hepatic blood flow will be recorded
    E.5.2Secondary end point(s)
    The evaluation of the effect of dobutamine on systemic hemodynamic measurements (CI, HR, SAP, DAP, MAP, CVP, SVV, PPV), systemic vascular resistance (SVR), SVRI, dPmx and portal venous resistance (PVR).
    The effect of dobutamine on hemodynamic data (HR, SAP, DAP, MAP, CI, PPV, SVV, CVP).
    E.5.2.1Timepoint(s) of evaluation of this end point
    T0 – start surgery.
    T1 – after pancreaticoduodenectomy, at baseline without dobutamine infusion.
    T3 – after minimum 10 minutes of infusion of dobutamine at 2 mcg/kg/min, before raising dobutamine infusion to 5 mcg/kg/min
    T2 through T4 – a measurement will be made every minute (together with the hepatic blood flow measurements)
    T4 – before surgical reconstruction, after minimum 10 minutes of infusion of dobutamine at 5 mcg/kg/min.
    T5 – end of surgery.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy No
    E.6.4Safety No
    E.6.5Efficacy Yes
    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 No
    E.8.1.1Randomised No
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    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) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    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 No
    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
    LPLV
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months6
    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: 25
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 45
    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 Yes
    F.3.3.1Women of childbearing potential not using contraception For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2021-02-23. Yes
    F.3.3.2Women of child-bearing potential using contraception Yes
    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 state70
    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)
    standard of care
    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 Decision2021-03-18
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-04-06
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2023-07-25
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