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    Summary
    EudraCT Number:2017-003714-68
    Sponsor's Protocol Code Number:1744/2017
    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:2017-10-06
    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 number2017-003714-68
    A.3Full title of the trial
    Effect of Supplemental Oxygen on Perioperative Brain Natriuretic Peptide Concentration in Cardiac Risk Patients -
    A prospective randomized clinical trial
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Effect of Supplemental Oxygen on Heart Function Blood Parameters
    A.4.1Sponsor's protocol code number1744/2017
    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 SponsorMedical University of Vienna
    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 supportDepartment of Anaesthesia, Critical Care and Pain Management
    B.4.2CountryAustria
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationDepartment for Anaesthesia, Office Care and Pain Management
    B.5.2Functional name of contact pointHead Office
    B.5.3 Address:
    B.5.3.1Street AddressWaehringer Guertel 18-20
    B.5.3.2Town/ cityVienna
    B.5.3.3Post code1090
    B.5.3.4CountryAustria
    B.5.4Telephone number0043(0) 140400 41020
    B.5.5Fax number0043(0) 140400 39200
    B.5.6E-mailsekretariat-anaesthesie@meduniwien.ac.at
    D. IMP Identification
    D.IMP: 1
    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.2.1.2Country 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 nameOxygen
    D.3.4Pharmaceutical form Medicinal gas, liquefied
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPInhalation use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNOXYGEN
    D.3.9.1CAS number 7782-44-7
    D.3.9.2Current sponsor codeOxygen
    D.3.9.3Other descriptive namemolecular oxygen, oxygen molecule, pure oxygen, dioxygen
    D.3.9.4EV Substance CodeSUB14733MIG
    D.3.10 Strength
    D.3.10.1Concentration unit % (V/V) percent volume/volume
    D.3.10.2Concentration typenot less then
    D.3.10.3Concentration number99,5
    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
    Evaluation of the effect of 80% versus 30% supplemental oxygen administration during major abdominal surgery on postoperative brain natriuretic peptide concentration.

    E.1.1.1Medical condition in easily understood language
    The effect of oxygen on heart function.
    E.1.1.2Therapeutic area Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10059883
    E.1.2Term Fraction of inspired oxygen
    E.1.2System Organ Class 10042613 - Surgical and medical procedures
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10050322
    E.1.2Term Oxygen supplementation
    E.1.2System Organ Class 100000173317
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Due to the significant reduction of BNP by inhibiting sympathic nerve activity we hypothesize that supplemental oxygen have beneficial effects in perioperative BNP release in cardiac risk patients undergoing major abdominal surgery.
    E.2.2Secondary objectives of the trial
    1) Effect of supplemental oxygen on postoperative troponin T concentration.
    2) Influence of supplemental oxygen on perioperative plasma catecholamine concentration.
    3) The effect of oxygen on the redox potential.
    4) The effect of hyperoxia on needed vasopressor for hemodynamic stability due to enhanced vasoconstriction
    5) Endothelial release of vWF in order to evaluate the endothelial response to supplemental oxygen.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Patients over 45 years on age, which fulfill 1 or more of the following 4 criteria undergoing non-cardiac surgery:
    1. History of coronary artery disease
    2. History of peripheral arterial disease
    3. History of stroke OR
    4. Any of 3 of 7
    A) Age ≥ 70 years
    B) Undergoing major surgery
    C) History of congestive heart failure
    D) History of transient ischemic attack
    E) Diabetes and currently taking an oral hypoglycemic agent or insulin
    F) History of Hypertension


    Further inclusion criteria are:
    1. Written informed consent
    2. Elective major abdominal open surgery or laparoscopically assisted procedures scheduled to take over two hours done under general anesthesia (colorectal, urology, gynecology, liver and pancreatic surgery)
    E.4Principal exclusion criteria
    1. Symptoms of infection or sepsis
    2. Preoperative inotropic therapy
    3. Patients under ICU treatment
    4. Oxygen dependent patients
    5. History of severe heart failure and/or EF < 30%
    E.5 End points
    E.5.1Primary end point(s)
    Supplemental oxygen leads to a significant reduction of BNP in patients suffering congestive heart failure due to inhibiting of sympathic nerve activity. In the following trial, we want to evaluate the effect of supplemental intraoperative oxygen in cardiac risk patients undergoing major surgery. Our primary outcome parameter will be the perioperative brain natriuretic peptide.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Brain natriuretic peptide measurement will be performed within 2 hours after end of surgery, on postoperative day 1, 3 and before discharge but at least within 72hours.
    E.5.2Secondary end point(s)
    1) Harmful effects of hyperoxia were described in patients suffering acute myocardial syndrome, however almost no data exists about patients in the perioperative setting without an acute myocardial event. Myocardial injury after noncardiac surgery (MINS) is associated with significant increased 30-day mortality. Patients with a troponin T level > 0.04ng/l will be assessed for ischemic features.
    2) All participants will be monitored for cardiac morbidity as there are:
    a) myocardial infarction requiring medical intervention,
    b) acute heart failure requiring medical therapy (diuretics, positive inotropes therapy, invasive and non-invavisve respiratory support)
    c) new onset of cardiac arrhythmias needing intervention
    d) unplanned ICU admission due to cardiac events.
    3) Patients experience a significant raise in plasma catecholamines during surgery. Because of the association between intraoperative raise of catecholamines and postoperative cardiovascular risk we will also measure perioperative catecholamine (e.g. adrenaline, noradrenaline, dopamine) concentration. Supplemental oxygen leads to a decrease of sympathetic nerve activity followed by lower plasma catecholamine concentrations. Therefore, we perform a baseline measurement immediately after induction of anesthesia, one after surgery and one on third postoperative day.
    4) The antioxidant capacity of a plasma sample, will be measured based on the electrical conductance relative to an internal reference standard. The plasma sample will be obtained preoperatively, hourly and immediately after end of surgery and on postoperative day 1 and 3 and before discharge but at least within 72hours.
    5) Supplemental oxygen might have a vasopressor sparing effect. Consequently, the number of administered boluses as well as the total dose of phenylephrine and norepinephrine will be recorded.
    6) The immune modulator effect of supplemental oxygen remains still unknown. Because of an enhanced endothelial vWF release during inflammation, we will further measure the vWF plasma level in order to evaluate the endothelial response to supplemental oxygen.
    E.5.2.1Timepoint(s) of evaluation of this end point
    1) Troponin T will be measured within 2 hours after end of surgery, on postoperative day 1 and 3.
    2) Outcome parameters concerning cardiac morbidity as mentioned before will be evaluated within 48 hours before hospital discharge and on postoperative day 30 through phone follow up.
    3) Plasma catecholamines will be obtained within 2 hours after end of surgery and on postoperative day 1.
    4) The oxidation-reduction of potential will be measured every hour during surgery, 2 hours within end of surgery and within 48 hours before hospital discharge.
    5) The overall amount of administered vasopressor to maintain hemodynamic stability will be recorded.
    6) Measurement of vWF will be performed within 2 hours after end of surgery, on postoperative day 1 and 3.
    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 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 No
    E.8.1.3Single blind Yes
    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) No
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    Comparison of intraoperative administration of different oxygen concentration (30% versus 80%)
    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 years3
    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.1.3Elderly (>=65 years) Yes
    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 state260
    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)
    There is no difference from the normal treatment after the study subject has ended the participation in this trial.
    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 Decision2017-11-15
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-10-10
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2020-01-31
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