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    Summary
    EudraCT Number:2005-004602-86
    Sponsor's Protocol Code Number:
    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:2005-10-17
    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 number2005-004602-86
    A.3Full title of the trial
    A comparison of crystalloids vs. colloids for intraoperative goal-directed fluid management
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A comparison of crystalloids vs. colloids for intraoperative goal-directed fluid management
    A.3.2Name or abbreviated title of the trial where available
    Crystalloids vs. colloids during surgery
    A.4.1Sponsor's protocol code number
    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 support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    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 No
    D.2.1.1.1Trade name Voluven
    D.2.1.1.2Name of the Marketing Authorisation holderFresenius Kabi
    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.3.1Product nameVoluven
    D.3.4Pharmaceutical form 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.3.9.1CAS number 9004-62-0
    D.3.10 Strength
    D.3.10.1Concentration unit g gram(s)
    D.3.10.2Concentration typeup to
    D.3.10.3Concentration number60
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboSolution for infusion
    D.8.4Route of administration of the placeboIntravenous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Fluid optimization has been considered as major contributor to improved oxygen delivery, and thus improved outcome in patients. Hypovolemia has been associated with significant increases in morbidity and mortality. Administering volume deliberately, however, also may have undesired effects like hemodynamic deterioration, pulmonary edema, tissue edema, and decreased O2-delivery.
    E.1.1.1Medical condition in easily understood language
    Fluid optimization to improved oxygen delivery, and thus improved outcome in patients
    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
    1. To test whether colloid-based goal-directed intraoperative fluid management leads to less perioperative morbidity compared to crystalloid-based goal-directed intraoperative fluid management.

    E.2.2Secondary objectives of the trial
    2. To compare colloid- vs. crystalloid-based goal-directed intraoperative fluid management on the outcome of various organ systems.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    After IRB approval and written informed consent patients aged 18 to 80 and scheduled for elective open abdominal surgery, open hysterectomy or myomectomy, or open urologic surgery (open prostatectomies and open cystectomies with ileal conduit formation) will be included in the study. Patients will be assigned to two groups:
    E.4Principal exclusion criteria
    We will exclude patients having cardiac (EF<35%) or renal insufficiency (creatinine clearance < 30ml/min, or on renal replacement therapy), coronary (NYHA IV) or peripheral artery disease, COPD, coagulopathies, symptoms of infection or sepsis, or a history of susceptibility to malignant hyperthermia or porphyria. Participants in other studies will be excluded, when an interference of the studies cannot be ruled out. Operating Room records indicate that sufficient qualifying patients will be available to complete the proposed studies within the requested timetable.
    E.5 End points
    E.5.1Primary end point(s)
    We will evaluate post-operative morbidity. This is the primary outcome parameter of the study and will define the stopping point of the study. Postoperative morbidity will be assessed daily with a postoperative morbidity survey [40] by a team member strictly blinded to group assignment. We add mortality end rehospitalization within 30 postoperative days.
    E.5.1.1Timepoint(s) of evaluation of this end point
    refer to 5.1
    E.5.2Secondary end point(s)
    Subcutaneous oxygen tension (PsqO2) will be evaluated intraoperatively in a subgroup of 60 patients with a polarographic-type tissue oxygen sensor (Licox, Inc. Germany) positioned within a subcutaneous, saline filled Silastic® tonometer inserted into the patients’ upper arm after induction of anesthesia. (Silastic® readily permits transfer of oxygen by diffusion.) It has been shown previously, that subcutaneous oxygen tension in the upper arm is comparable to oxygen tension at the side of chest and abdominal wounds though it is about 10 mmHg higher than in the incised wound [41]. The arm is chosen, because it is convenient and can be accessed intraoperatively.

    The tonometer consists of a Luer-hubbed, 15-cm-long segment of Silastic® tubing (internal diameter, 0,8 mm; external diameter, 1.0 mm). Under controlled conditions, the optode measures p02 accurately and reliably in vitro over a broad range of p02 values and temperatures. In vitro accuracy of the optode (in a water bath at 37 C) is ± 3 mmHg for the range from 0-100 mmHg, and ± 5% for the range 100-360 mmHg. Temperature sensitivity is 0.25%/°C, but a thermistor is incorporated into the probe and temperature-compensation is included in the PsqO2 calculation. The calibration remains stable (within 8% of baseline value for room air) in vitro for at least 72 hours and in vivo for at least 8 hours.
    The polographic sensor will be initially calibrated, as in our previous studies, by exposing it to room air (pO2=154 mmHg). It will then be inserted into the Silastic® tonometer, which will be flushed with hypoxic saline to provide more rapid equilibration with the surrounding tissue. The optode will be allowed to equilibrate with tissue oxygen for at least 30 minutes. It was shown that this time period is sufficient for any clinically observed PsqO2. It also was shown that PsqO2 values correlate well with the incidence of clinically significant wound infections. Measurements will start as soon as practical after induction of anesthesia.
    Values will be recorded at 10-minute intervals during surgery as well as during the first two hours of recovery, and on the first postoperative day, respectively. The silastic tonometer will be removed immediately after the investigation period.
    As the tissue of interest for colon surgery is the gut we will measure intramural intestinal oxygen partial pressure (PimO2) intraoperatively. Surgeons will insert oxygen sensors through 20-g-cannulae into a section of the descending colon(approximately 20 cm away from the tumor) that will subsequently be resected. The probes will be inserted into the tissue plane between the serosa and mucosa after mobilization of the left colon. Additionally, needle temperature probes will be inserted adjacent to the oxygen probes(Tyco-mallinckrodt Anesthesiology Products). In order to obtain temperature corrected measurements, we will adjust the Licox monitor according to the measured temperature. PimO2 will be measured every 60 seconds for fifteen minutes, surgery will be discontinued during PimO2 measurements.
    At the end of surgery, a tonometer will be inserted 2-3 cm lateral and parallel to the surgical incision to measure wound tissue oxygen tension (PsqO2 wound) 2 hours postoperatively every ten minutes.
    E.5.2.1Timepoint(s) of evaluation of this end point
    seee 5.2
    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 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 Yes
    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.8.4.1Number of sites anticipated in Member State concerned1
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA1
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    United States
    E.8.7Trial has a data monitoring committee Yes
    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
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years9
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years9
    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 No
    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 state
    F.4.2 For a multinational trial
    F.4.2.2In the whole clinical trial 1112
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    G.4.1Name of Organisation Cleveland Clinic Lerner College of Medicine
    G.4.3.4Network Country United States
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2005-11-21
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2005-11-21
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2016-12-31
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