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    Summary
    EudraCT Number:2010-024225-20
    Sponsor's Protocol Code Number:301110_PALANCE
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2014-04-04
    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 ConcernedGermany - BfArM
    A.2EudraCT number2010-024225-20
    A.3Full title of the trial
    The impact of phosphate balanced cristalloid infusion on acid-base homeostastis
    Auswirkungen einer balancierten Infusionslösung mit Phosphatzusatz auf den Säure-Basen-Haushalt
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Effects of a continuous application of fluids enriched with phosphate on the patients' proper balance of acids and bases during surgery.
    Auswirkungen einer kontinuierlichen Verabreichung von phosphatangereicherter Infusionsflüssigkeit auf den Säure-Basen-Haushalt des Menschen im Rahmen von operativen Eingriffen.
    A.3.2Name or abbreviated title of the trial where available
    PALANCE
    A.4.1Sponsor's protocol code number301110_PALANCE
    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 SponsorUniversity Hospital Munich, Germany
    B.1.3.4CountryGermany
    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, University Hospital of Munich, Munich, Germany
    B.4.2CountryGermany
    B.4.1Name of organisation providing supportFresenius Kabi Deutschland GmbH
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUniversity Hospital Munich
    B.5.2Functional name of contact pointProf. Dr. med. Markus Rehm
    B.5.3 Address:
    B.5.3.1Street AddressMarchioninistrasse 15
    B.5.3.2Town/ cityMunich
    B.5.3.3Post code81377
    B.5.3.4CountryGermany
    B.5.4Telephone number+49(0)89440073402
    B.5.5Fax number+49(0)89440078886
    B.5.6E-mailmarkus.rehm@med.uni-muenchen.de
    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 Jonosteril®
    D.2.1.1.2Name of the Marketing Authorisation holderFresenius Kabi Deutschland GmbH
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    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 Infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous 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.IMP: 2
    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 Sodiumglycerophosphate
    D.2.1.1.2Name of the Marketing Authorisation holderFresenius Kabi Deutschland GmbH
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    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 INNSODIUM GLYCEROPHOSPHATE
    D.3.9.1CAS number 1555-56-2
    D.3.9.3Other descriptive nameSODIUM GLYCEROPHOSPHATE
    D.3.9.4EV Substance CodeSUB15289MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mmol/l millimole(s)/litre
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number1 to 6
    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
    This study aims to investigate a new crystalloid fluid therapy regime for the perioperative setting providing stable fluid and acid-base homeostasis in the patient.
    E.1.1.1Medical condition in easily understood language
    We aim to investigate a new fluid therapy for the patient undergoing surgery in the operating theatre.
    E.1.1.2Therapeutic area Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]
    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
    An aedequate perioperative fluid therapy should be capable of replacing fluid (such as urinary output and insensible perspiration) and limited blood losses without disturbing fluid and acid-base homeostasis within the human body. With the use of state of the art crystalloids preparations we often observe the onset of a hyperchloremic acidosis with all its negative consequences like the reduction of renal function, among others. Our hypothesis is based on the Stewart model of acid-base balance where albumin and phosphate, referred to as weak acids (A-), are capable of regulating the pH. Adding sodium glycerophosphate to an established crystalloid preparation, our main objective is to stabilize the level of A- in the patient in order to maintain constant acid-base conditions.
    E.2.2Secondary objectives of the trial
    Secondary objectives of the trial are :

    the effects of the crystalloid preparation on
    -The onset and severity of postoperative nausea and vomiting (PONV)
    -Other Stewart acid-base parameters
    -Electrolyte levels and their excretion in the urine
    -Hemodynamics
    -Amounts of catecholamines and vasopressors used

    and the safety of the infusion regime
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • only female patients who have given their informed consent
    • ASA I-III classified female patients, who are scheduled for an extended abdominal surgical procedure under general anesthesia with routinely planned placement of a central venous and arterial catheter
    • age ≥ 18 years
    E.4Principal exclusion criteria
    •participation in another clinical trial
    •patients who are not personally able to giver their informed consent
    •patients at a childbearing age without using contraceptives
    • acute or chronic renal failiure (glomerular filtration rate <60ml/min)
    • patients suffering from acid-base-dysregulation (i.e. severe acidosis, sepsis, SIRS)
    • pregnancy or lactation period (pregnancy testing will be executed on the ward at least one day prior to the surgical procedure)
    • edema, hypertonic dehydratation, hyperhidratation
    • hyperphosphatemia, hypernatremia,hypocalcemia
    • known hypersensitivity against IMPs and/or other components
    • known history or active abuse of alcohol and/or drugs
    E.5 End points
    E.5.1Primary end point(s)
    Calculation of the week acids concentration (A-) according to the Stewart approach of acid-base balance:
    A- = albumin x (0.123 x pH – 0.631) + phosphate x (0.309 x pH - 0.469)
    E.5.1.1Timepoint(s) of evaluation of this end point
    Calculation takes place after measurement of pH, serum phosphate and albumin during distinct timepoints (every 30 minutes until 120 minutes after the induction of anesthesia)
    E.5.2Secondary end point(s)
    1) analysis of serum phosphate levels
    2) analysis of acid-base parameters: pH, paCO2, HCO3-, BE, anion gap
    3) analysis of Strong Ion Difference (SID), Effective Strong Ion Difference, Strong Ion Gap, albumin, lactate
    4) serum and urine analysis of electrolytes
    5) documentation of blood pressure, heart frequency, demand of catecholamines and vasopressors, variation in stroke volume and cardiac output
    6)analysis of creatinine and urea as well as calculation of glomeraular filtration rate
    7) analysis of glykokalix components (hyaluronic acid, syndecan-1)
    8) evaluation and documentation of postoperative nausea and vomiting
    E.5.2.1Timepoint(s) of evaluation of this end point
    1)-5) starting after induction of anesthesia (T1) on the day of the surgical procedure until 120min after T1
    6) one day prior to the surgical procedure as well as on day 3
    7) T1 -T5
    8) at the end of the surgical procedure as well as on day 1 and 3 after surgery
    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 Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    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 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 years1
    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: 28
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 20
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male No
    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 state48
    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 Decision2014-05-19
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-08-22
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2020-03-26
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