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    Summary
    EudraCT Number:2013-002051-15
    Sponsor's Protocol Code Number:KM-HYPO
    National Competent Authority:Austria - BASG
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2014-09-22
    Trial results View 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 ConcernedAustria - BASG
    A.2EudraCT number2013-002051-15
    A.3Full title of the trial
    Systemic hypotension following intravenous administration of contrast medium during computed tomography.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Systemic hypotension following intravenous administration of contrast medium during computed tomography.
    A.4.1Sponsor's protocol code numberKM-HYPO
    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 SponsorInnsbruck Medical University, Department of Radiology, Section of Microinvasive Therapy
    B.1.3.4CountryAustria
    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 supportGE Healthcare
    B.4.2CountryAustria
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationInnsbruck Medical University, Department of Radiology, Section of Microinvasive Therapy
    B.5.2Functional name of contact pointInvestigator
    B.5.3 Address:
    B.5.3.1Street AddressAnichstrasse 35
    B.5.3.2Town/ cityInnsbruck
    B.5.3.3Post codeA 6020
    B.5.3.4CountryAustria
    B.5.4Telephone number+4351250480927
    B.5.5Fax number+435125046780927
    B.5.6E-mailgerlig.widmann@i-med.ac.at
    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 VISIPAQUE 320 mg J/ml - parenterale Röntgenkontrastmittellösung
    D.2.1.1.2Name of the Marketing Authorisation holderGE Healthcare Handels GmbH
    D.2.1.2Country which granted the Marketing AuthorisationAustria
    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 nameVISIPAQUE 320 mg J/ml - parenterale Röntgenkontrastmittellösungle Röntgenkontrastmittellösung
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPParenteral use (Noncurrent)
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNIODIXANOL
    D.3.9.1CAS number 92339-11-2
    D.3.9.4EV Substance CodeSUB08213MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number320
    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 Ultravist 370 mg J/ml - Infusionsflaschen
    D.2.1.1.2Name of the Marketing Authorisation holderBayer Austria GmbH
    D.2.1.2Country which granted the Marketing AuthorisationAustria
    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 nameUltravist 370 mg J/ml - Infusionsflaschen
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPParenteral use (Noncurrent)
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNIOPROMIDE
    D.3.9.1CAS number 73334-07-3
    D.3.9.3Other descriptive nameIOPROMIDE
    D.3.9.4EV Substance CodeSUB08244MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number370
    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
    Primary goal of this study is to quantify changes in systolic and diastolic blood pressure, heart rate and pO2 before and after i.v. administration of either IOCM or LOCM. In particular the occurrence of clinically relevant drops in systolic and diastolic blood pressure after IOCM or LOCM administration is investigated.
    E.1.1.1Medical condition in easily understood language
    Primary goal of this study is to quantify changes in systolic and diastolic blood pressure, heart rate and pO2 before and after i.v. administration of either IOCM or LOCM.
    E.1.1.2Therapeutic area Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Diagnosis [E01]
    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
    Primary goal of this study is to quantify changes in systolic and diastolic blood pressure, heart rate and pO2 before and after i.v. administration of either IOCM or LOCM. In particular the occurrence of clinically relevant drops in systolic and diastolic blood pressure after IOCM or LOCM administration is investigated.
    E.2.2Secondary objectives of the trial
    Secondary goal is to evaluate potential differences in changes in systolic and diastolic blood pressure, heart rate and pO2 before and after i.v. administration of CM (either LOCM or IOCM) or the equal amount of normo-saline solution.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Primary or secondary liver tumors treatable by SRFA.
    • Approval of an interdisciplinary cancer board for SRFA.
    • Adult patients > 18 years, American Society of Anesthesiologists (ASA) score I-III, scheduled for radiological interventions with CM (obligate application) under general anesthesia.
    E.4Principal exclusion criteria
    • Reduced mental status of the patient, history of psychiatric disorder, refusal by patient, failure to obtain written and informed consent.
    • Primary or secondary liver tumors larger than 12 cm in diameter or prediction of insufficient liver remnant, more than 7 lesions, lesions within 1 cm distance to the central bile duct, lesions infiltrating adjacent hollow viscera.
    • Liver cirrhosis classified higher than Child-Pugh class B, manifest ascites.
    • Estimated glomerular filtration rate (eGFR) <45.
    • Clotting disorders (PT < 50%, apTT >50 sec and thrombocytes < 50,000/mm3) or recent intake of platelet aggregation inhibitors
    • Evidence of intolerance or allergic reactions against both CM.
    • Contraindications to both CM according to Austrian Fachinformation
    • Antihypertensive treatment except Midazolam (Dormicum®, Roche Pharmaceutics, Vienna, Austria) orally 30 minutes prior to surgery at dose between 3.75 and 7.5 mg.
    E.5 End points
    E.5.1Primary end point(s)
    Primary study endpoint of this study is to quantify changes in systolic and diastolic blood pres-sure, heart rate and pO2 before and after i.v. administration of either IOCM or LOCM. In particular the occurrence of clinically relevant drops in systolic and diastolic blood pressure after IOCM or LOCM administration is investigated.
    E.5.1.1Timepoint(s) of evaluation of this end point
    1: End of induction of general anesthesia and positioning of the patient (=baseline) and the lowest value measured within 3 minutes after
    2: Planning CT after i.v. administration of CM.,
    3: Control CT 1 (needle placement) after i.v. administration of normo-saline solution (same amount and injection rate as in step 2), and
    4: Control CT 2 (ablation size) after i.v. administration of CM (same CM, amount and injection rate as in step 2). The interval to return of baseline blood pressure is recorded and the mean duration calculated.
    E.5.2Secondary end point(s)
    Secondary endpoint is to evaluate potential differences in changes in systolic and diastolic blood pressure before and after i.v. administration of CM (either LOCM or IOCM) or the equal amount of normo-saline solution.
    E.5.2.1Timepoint(s) of evaluation of this end point
    48 hrs
    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 Yes
    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 No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    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) Yes
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    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
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months10
    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) No
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 10
    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 No
    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 state40
    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
    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 Decision2014-11-04
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-10-01
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2015-07-22
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