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    Summary
    EudraCT Number:2014-004867-19
    Sponsor's Protocol Code Number:v1330032015
    National Competent Authority:Austria - BASG
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2015-01-20
    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 number2014-004867-19
    A.3Full title of the trial
    Perioperative fluid management in patients receiving major abdominal surgery – Effects of normal saline versus an acetate buffered balanced infusion solution on the necessity of catecholamines for cardiocirculatory support
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Perioperative fluid management in patients undergoing major surgery and its effect on blood pressure
    A.4.1Sponsor's protocol code numberv1330032015
    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 SponsorClinic for General Anesthesiology, Intensive Care and Pain Management
    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 supportMedical University of Vienna
    B.4.2CountryAustria
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationClinic for General Anesthesiology, Intensive Care and Pain Management
    B.5.2Functional name of contact pointHead of Department
    B.5.3 Address:
    B.5.3.1Street AddressWaehringerstrasse 18-20
    B.5.3.2Town/ cityVienna
    B.5.3.3Post code1090
    B.5.3.4CountryAustria
    B.5.4Telephone number0041140100
    B.5.6E-mailanesthesie@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.2.1.1.1Trade name Elomel isoton Fresenius Kabi Austria GmbH
    D.2.1.1.2Name of the Marketing Authorisation holderFresenius Kabi
    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 nameElomel isoton
    D.3.4Pharmaceutical form Infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous drip use (Noncurrent)
    Intravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INN-
    D.3.9.1CAS number 8026-10-6
    D.3.9.2Current sponsor code1
    D.3.9.3Other descriptive nameRINGER'S ACETATE SOLUTION
    D.3.9.4EV Substance CodeSUB33359
    D.3.10 Strength
    D.3.10.1Concentration unit mmol/l millimole(s)/litre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number302
    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 Physiologische Kochsalzlösung Fresenius-Infusionslösung
    D.2.1.1.2Name of the Marketing Authorisation holderFresenius Kabi
    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 namePhysiologische Kochsalzlösung
    D.3.4Pharmaceutical form Infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous bolus use (Noncurrent)
    Intravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INN-
    D.3.9.1CAS number -
    D.3.9.2Current sponsor code2
    D.3.9.3Other descriptive nameSODIUM CHLORIDE SOLUTION 0.9%
    D.3.9.4EV Substance CodeSUB20079
    D.3.10 Strength
    D.3.10.1Concentration unit mmol/l millimole(s)/litre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number154
    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
    hemodynamic stability of patients undergoing major surgery
    E.1.1.1Medical condition in easily understood language
    patients undergoing major surgery
    E.1.1.2Therapeutic area Diseases [C] - Cardiovascular Diseases [C14]
    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
    In this study we want to clarify whether a balanced type fluid solution for perioperative fluid management of patients receiving major abdominal surgery is associated with a lower incidence of need for catecholamines for hemodynamic stability than use of isotonic saline.
    E.2.2Secondary objectives of the trial
    balanced infusion solutions results in a lower volume of fluid needed to achieve cardiovascular stability, lower total dosage of catecholamines as well as lower frequency of unexpected intensive care unit transfers (ICU) than with administration of isotonic saline. Additionally, we will evaluate whether use of an acetate buffered balanced infusion solutions results in lower incidence rates of metabolic acidosis and electrolyte disorders than use of isotonic saline.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    All patients scheduled for open elective major abdominal surgery and expected to last a minimum of 2 hours will be included in the study.
    Major abdominal surgery includes all gynecological, urological and general surgical operations requiring laparotomy.
    Major general surgery includes complex visceral resection (surgery involving the liver, esophagus, pancreas or multiple organs), partial or total colectomy, stomach surgery, small bowel resection, open gall-bladder resection, splenektomie, adrenalektomie and regional lymphnode dissection. Major urological or gynecological surgery includes renal transplant, nephrectomie, visceral resection (ureterectomy, bladder resection, retroperitoneal tumor resection, exenteration), cytoreductive surgery (tumor debulking), radical hysterectomy, radical prostatectomy and open hysterectomy.
    E.4Principal exclusion criteria
    - Patients younger than 18 years of age
    - Patients unable to give informed consent
    - Pregnancy or breastfeeding
    - Patients transferred form the intensive care unit to the operating theater
    - Patients with an already established catecholamine therapy
    - Emergency operation
    - Chronic inflammatory diseases (chronic inflammatory rheumatoid diseases, chronic inflammatory renal diseases, chronic inflammatory infectious diseases, chronic inflammatory bowel diseases, chronic liver disease with signs of liver insufficiency)
    - Severe cardiovascular disease (heart disease with an ejection fraction below 30%, instable coronary syndroms, severe valvular disease)
    - Any signs of infection or sepsis
    - Any contraindication for oesophageal Doppler monitoring (oesophageal and aortic pathology, planned oesophageal resection)
    - Patients with additional epidural anesthesia are excluded from the study if epidural anesthesia is planned to be used for analgesia intraoperatively.
    - Patients not able to understand the consenting information without help of a translator are excluded from the study.
    E.5 End points
    E.5.1Primary end point(s)
    necessity of catecholamines for cardiocirculatory support
    E.5.1.1Timepoint(s) of evaluation of this end point
    necessity of catecholamines for cardiocirculatory support yes or no
    E.5.2Secondary end point(s)
    - time of vasopressor start
    - dose of vasopressor start
    - type of vasopressor used
    - maximal dose of vasopressor
    - frequency of vasopressor use
    - cumulative intraoperative vasopressor dose per kg of body weight
    - cumulative intraoperative crystalloids
    - total amount of fluid given at the time of the start of the catecholamine therapy
    E.5.2.1Timepoint(s) of evaluation of this end point
    end of operation
    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 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 years2
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    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: 240
    F.1.3Elderly (>=65 years) No
    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.3.3.6.1Details of subjects incapable of giving consent
    no risk for this group
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state240
    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 post trial treatment
    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 Decision2015-02-24
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-12-11
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2016-04-24
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