Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   43865   clinical trials with a EudraCT protocol, of which   7286   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Print Download

    Summary
    EudraCT Number:2016-001313-24
    Sponsor's Protocol Code Number:SUPERADD
    National Competent Authority:Germany - PEI
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2016-09-05
    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 - PEI
    A.2EudraCT number2016-001313-24
    A.3Full title of the trial
    SUbstition of PERioperative Albumin Deficiency Disorders
    Einfluss der Therapie einer perioperativen Hypoalbuminämie auf postoperative Komplikationen
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Can the compensation of protein deficits, which occur during or after surgery, improve outcome after surgery?
    Kann der Ausgleich eines Eiweißmangels, der während oder unmittelbar nach einer Operation auftritt den Krankheitsverlauf nach einer Operation verbessern?
    A.3.2Name or abbreviated title of the trial where available
    SUPERADD
    A.4.1Sponsor's protocol code numberSUPERADD
    A.5.3WHO Universal Trial Reference Number (UTRN)U1111-1181-2625
    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 SponsorTechnische Universität München, Fakultät für Medizin
    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 supportKlinik für Anaesthesiologie des Klinikums rechts der Isar der TUM
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationTechnische Universität München, Fakultät für Medizin
    B.5.2Functional name of contact pointKlinik für Anästhesiologie
    B.5.3 Address:
    B.5.3.1Street AddressIsmaningerstr. 22
    B.5.3.2Town/ cityMunich
    B.5.3.3Post code81675
    B.5.3.4CountryGermany
    B.5.4Telephone number498941409635
    B.5.5Fax number498941406282
    B.5.6E-mails.schaller@tum.de
    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 Human-Albumin 20 % Behring, salzarm Infusionslösung
    D.2.1.1.2Name of the Marketing Authorisation holderCSL Behring 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.3.1Product nameHuman-Albumin 20 % Behring, salzarm
    D.3.4Pharmaceutical form Solution for injection/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 No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    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 Yes
    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
    High risk surgical patients or procedures showing a hypoalbuminemia intraoperatively.
    Hochrisiko-patienten und -operationen bei denen sich intraoperativ eine Hypoalbuminämie zeigt.
    E.1.1.1Medical condition in easily understood language
    Patients during an operation showing or developing a low level of albumin (an important blood protein).
    Patienten während einer Operation, die eine niedrige Konzentration von Albumin (ein wichtiges Protein im Blut) aufweisen oder entwickeln.
    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 10005286
    E.1.2Term Blood albumin abnormal
    E.1.2System Organ Class 10022891 - Investigations
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10005287
    E.1.2Term Blood albumin decreased
    E.1.2System Organ Class 10022891 - Investigations
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.1
    E.1.2Level LLT
    E.1.2Classification code 10020943
    E.1.2Term Hypoalbuminemia
    E.1.2System Organ Class 10027433 - Metabolism and nutrition disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10020942
    E.1.2Term Hypoalbuminaemia
    E.1.2System Organ Class 10027433 - Metabolism and nutrition disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Reduction of postoperative complications of either high-risk surgical procedures or high-risk surgical patients through perioperative therapy of hypoalbuminemia (defined as <30g/l).
    Verringerung postoperativer Komplikationen nach operativen Hochrisiko-Eingriffen oder bei Hochrisiko-Patienten, welcher sich einer Operation unterziehen, durch gezielte Therapie einer perioperativen Hypalbuminämie (definiert als <30g/l)
    E.2.2Secondary objectives of the trial
    Amelioration of the below defined secondary outcomes of either high-risk surgical procedures or high-risk surgical patients through perioperative therapy of hypoalbuminemia (defined as <30g/l).
    Verbesserung der unten definierten sekundären Endpunkte nach operativen Hochrisiko-Eingriffen oder bei Hochrisiko-Patienten, welcher sich einer Operation unterziehen, durch gezielte Therapie einer perioperativen Hypalbuminämie (definiert als <30g/l)
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. patients older than 18 years
    2. patients, who voluntarily signed the consent form of the study
    3. a. ASA III or IV
    OR
    b. planned high risk surgery: open aortic surgery, open revascularization of lower limbs, esophagectomy, cystectomy, pancreatic surgery, hepatic surgery, thrombectomy/embolectomy, amputation of a limb, replacement of artificial hip or knee joint
    1. Personen 18 Lebensjahre
    2. Patienten, die ihr schriftliches Einverständnis zur Teilnahme an der Studie gegeben haben

    3. a. ASA III und IV
    ODER
    b. geplanter operativer Hochrisikoeingriff: Offene Aortenchirurgie, Offene Revaskularisierung der Beine, Ösophagektomie, Zystektomie, Pankreaschirurgie, Leberchirurgie, Thrombektomie/Embolektomie, Amputation, Hüft- oder Knie-TEP Wechsel
    E.4Principal exclusion criteria
    1. emergency surgery
    2. severe liver cirrhosis (Child Pugh C)
    3. terminal renal insufficiency needing renal replacement therapy
    4. patients, who have been randomized in SUPERADD before
    5. patients having a caregiver in medical affairs
    6. patients with contraindications for albumin
    7. patients allergic to albumin or substances in the albumin preparation
    8. pregnant women
    9. breastfeeding women
    10. patient with a BMI > 35 kg/m2
    1. Notfalloperationen
    2. Schwere Leberzirrhose (Child Pugh C)
    3. Terminale Niereninsuffizienz mit Dialysepflichtigkeit
    4. Patienten, die bereits in SUPERADD eingeschlossen wurden
    5. Patienten, die einen Betreuer in medizinischen Angelegenheiten besitzen
    6. Patienten, bei denen Albumin kontraindiziert ist
    7. Patienten, die eine Überempfindlichkeit gegen Albuminpräparate oder gegen jegliche Hilfsstoffe der Zubereitung haben
    8. Frauen, die schwanger sind
    9. Frauen, die stillen
    10. Patienten mit BMI > 35 kg/m2
    E.5 End points
    E.5.1Primary end point(s)
    Postoperative Complications assessed by POMS (Postoperative Morbidity Survey) and Clavien-Dindo-Score.
    Postoperative Komplikationen erfasst mittels POMS (Postoperative Morbidity Survey) und Clavien-Dindo-Score.
    E.5.1.1Timepoint(s) of evaluation of this end point
    At hospital discharge
    Bei Krankenhausentlassung
    E.5.2Secondary end point(s)
    Secondary Outcomes are:
    1. PACU length of stay
    2. ICU length of stay
    3. hospital length of stay
    4. clavien dindo over the hospital stay
    5. hospital mortality
    6. Quality of recovery -9 (QoR-9) score on 1. and 3. postoperative day and 6 months after hospital discharge, including changes to base value (assessed during presurgical anesthesia assessment)
    7. incidence of 6 month mortality
    8. incidence of acute renal failure (acute kidney injury (AKI) ≥ 1)
    9. incidence of pulmonalvenous congestions (assessed by chest Xray)
    10. intra- and postoperative catecholamine requirements
    11. incidence and duration of intra- and postoperative hypotension (defined as values < 30% of basic value before anesthesia induction as well as vasopressor therapy)
    12. amount of infusions (anesthesia induction till PACU-discharge)
    13. amount of transfused red blood cell units (anesthesia induction till PACU-discharge)
    14. amount of transfused thrombocytes (anesthesia induction till PACU-discharge)
    15. amount of transfused clotting factors (PCC and fibrinogen, assessed from anesthesia induction till PACU discharge)
    16. new, intermittent or escalated diuretic therapy
    17. effectivitiy of albumin therapy to raise the albumin level and colloidosmotic pressure
    Sekundäre Endpunkte sind:
    1. Verweildauer im Aufwachraum
    2. Verweildauer auf der Intensivstation
    3. Verweildauer im Krankenhaus
    4. Clavien Dindo über den Krankenhausaufenthalt
    5. Krankenhausmortalität
    6. Quality of recovery -9 (QoR-9) score am 1. und 3. postoperativen Tag sowie nach sechs Monaten, sowie dessen Veränderung zum Basiswert (Erhebung während der Prämedikation)
    7. 6-Monats-Mortalität
    8. Inzidenz von akutem Nierenversagen (Acute kidney injury (AKI) ≥ 1)
    9. Inzidenz von pulmonalvenöser Stauung (bestimmt mittels Röntgen-Thorax)
    10. intra- und postoperativer Katecholaminbedarf
    11. Inzidenz und Dauer intra- und postoperativer Hypotonie (definiert als Werte < 30% des Ausgangswertes gemessen vor Narkoseeinleitung sowie Therapie mit Vasopressoren)
    12. Infusionsmenge (von Narkoseeinleitung bis Ende Aufwachraum)
    13. Menge an transfundierten Erythrozytenkonzentraten (von Narkoseeinleitung bis Ende Aufwachraum)
    14. Menge an transfundierten Thrombozytenkonzentraten (von Narkoseeinleitung bis Ende Aufwachraum)
    15. Menge an transfundierten Gerinnungsfaktoren (PPSB und Fibrinogen von Narkoseeinleitung bis Ende Aufwachraum)
    16. Neu angesetzte, intermittierende oder erweiterte Diuretikatherapie
    17. Effektivität der Albumintherapie zur Anhebung des Albuminspiegels und kolloidosmotischen Drucks
    E.5.2.1Timepoint(s) of evaluation of this end point
    Most secondary endpoints are assessed at hospital discharge. In addition, 6-months mortality and the QoR-9 are assessed 6 months after hospital discharge. Vasopressor requirements, hypotension, infusions, red blood cell units, thrombocyte transfusions and clotting factors are assessed from anesthesia induction till PACU discharge.
    Die meisten sekundären Endpunkte werden bis zur Krankenhausentlassung erfasst. Die 6-Monatsmortalität sowie ein QoR-9 Score wird 6 Monate nach Krankenhausentlassung erhoben. Katecholaminmenge, Hypotension, Infusionsmenge, Erythrozyten-, Thrombozyten- und Gerinnungssubstiution wird von Narkoseeinleitung bis zur Verlegung aus dem Aufwachraum erfasst.
    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 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 Yes
    E.8.1.7.1Other trial design description
    Auswerter verblindet
    Assessor blinded
    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
    Standardtherapie des Krankenhauses nach SOP
    Standard therapy according to hospital SOP
    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 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
    LVLS
    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 months4
    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: 210
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 390
    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 No
    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 state600
    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.
    Keine.
    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 Decision2017-02-13
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-09-14
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2020-06-03
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

    European Medicines Agency © 1995-Sat Apr 27 04:01:05 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA