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    Summary
    EudraCT Number:2017-000442-21
    Sponsor's Protocol Code Number:RC17_0029
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2017-04-21
    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 ConcernedFrance - ANSM
    A.2EudraCT number2017-000442-21
    A.3Full title of the trial
    Effects of perioperative administration of dexamethasone on postoperative complications and mortality after non-cardiac major surgery : a randomized, multicentre, double blind, study
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Effects of perioperative administration of dexamethasone on postoperative complications and mortality after non-cardiac major surgery : a randomized, multicentre, double blind, study
    A.3.2Name or abbreviated title of the trial where available
    PACMAN
    A.4.1Sponsor's protocol code numberRC17_0029
    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 SponsorCHU de Nantes
    B.1.3.4CountryFrance
    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 supportDGOS-PHRCN
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCHU de Nantes
    B.5.2Functional name of contact pointSandrine Cussonneau
    B.5.3 Address:
    B.5.3.1Street Address5 Allée de l'île Gloriette
    B.5.3.2Town/ cityNantes
    B.5.3.3Post code44093
    B.5.3.4CountryFrance
    B.5.4Telephone number0033253482430
    B.5.5Fax number0033253482836
    B.5.6E-mailsandrine.cussonneau@chu-nantes.fr
    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 DEXAMETHASONE MYLAN 20mg/5mL
    D.2.1.1.2Name of the Marketing Authorisation holderMYLAN SAS
    D.2.1.2Country which granted the Marketing AuthorisationFrance
    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 nameDEXAMETHASONE
    D.3.4Pharmaceutical form Solution for injection
    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 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 CHLORURE DE SODIUM LAVOISIER 0,9 POUR CENT
    D.2.1.1.2Name of the Marketing Authorisation holderLABORATOIRES CHAIX ET DU MARAIS
    D.2.1.2Country which granted the Marketing AuthorisationFrance
    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 nameCHLORURE DE SODIUM LAVOISIER 0,9 POUR CENT
    D.3.4Pharmaceutical form Solution for injection
    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.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 injection
    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
    non-cardiac major surgery
    E.1.1.1Medical condition in easily understood language
    non-cardiac major surgery
    E.1.1.2Therapeutic area Not possible to specify
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10042609
    E.1.2Term Surgery
    E.1.2System Organ Class 10042613 - Surgical and medical procedures
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Evaluate the effectiveness of perioperative administration of corticosteroid to reduce postoperative morbidity and mortality in patients undergoing major non-cardiac surgery
    E.2.2Secondary objectives of the trial
    - To evaluate the safety (clinical adverse events, especially glycaemic deregulation) of corticosteroids administration in patients undergoing major non-cardiac surgery
    - To evaluate the effect of corticosteroid administration on the incidence of postoperative infections, wound healing
    - To evaluate the effect of corticosteroid administration on postoperative gastrointestinal dysfunction
    - To evaluate the effect of corticosteroid administration on the duration of hospital stay
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Major surgery (> 90 minutes and realized under general anesthesia) of the abdomen, pelvis, thorax, face/neck, vascular surgery in a patient older than 65 years
    Or
    Major surgery (> 90 minutes and realized under general anesthesia) of the abdomen, pelvis, thorax, face/neck, vascular surgery in a patient older than 50 years and presenting one of the following criteria
    o Presence of a defined risk factor for cardiac or respiratory disease (exercise tolerance equivalent to 6 metabolic equivalents or less)
    o Medical history of stroke
    o Moderate to severe renal impairment (clearance of creatinine ≤ 30 mll/L)
    o Active smoking
    o Averaged observed blood losses over 500 ml
    o Emergency surgery
    E.4Principal exclusion criteria
    - Pregnant women, Minors, Adults under guardianship or trusteeship
    - Treatment with systemic corticosteroids at a dose > 5 mg.day-1 of equivalent prednisolone in the previous 3 months
    - Patients with chronic renal failure (clearance of creatinine < 10 ml/min)
    - Patients for which death is deemed imminent and inevitable or patients with an underlying disease process with a life expectancy of less than 1 month
    - Patient with preoperative shock (defined by the need for vasoactive drugs before surgery)
    - Acute Pulmonary edema in the last 7 days
    - Active bacterial or viral infection
    - Allergy to the intravenous formulation of dexamethasone
    - Uncontrolled psychotic disorder (acute or chronical)
    E.5 End points
    E.5.1Primary end point(s)
    Composite outcome (all-cause mortality and major postoperative complications) within 14 days after surgery, at least one item among the following:
    - Postoperative sepsis, severe sepsis, septic shock
    - Postoperative pulmonary complication (postoperative pneumonia, need for invasive ventilation and/or noninvasive ventilation for respiratory failure)
    E.5.1.1Timepoint(s) of evaluation of this end point
    14 days after surgery
    E.5.2Secondary end point(s)
    - All-cause mortality 28 days after randomization
    - Hospital free-days at 28 days
    - Surgical complications according to the Clavien-Dindo classification within 28 days following randomization
    - Duration of hospital stay (patients who will be outside the hospital but in other types of health care facilities at day 28 will be considered to have been discharged home)
    - Unplanned admission or readmission to critical care (within 28 days following randomization)
    - Proportion of patients who experience postoperative morbidity (all defined according to consensus criteria or universal definitions within 7 days after surgery) including:
    o renal dysfunction (according to the KDIGO criteria: Appendix 2),
    o cardiac complications (acute heart failure, myocardial infarction),
    o infectious complications (especially surgical site infection),
    o gastrointestinal dysfunction
    - Duration of invasive mechanical ventilation, Duration of non-invasive mechanical ventilation
    - SOFA score at day 1 and day 3 after surgery
    - Percentage of patients with new organ dysfunction (not present at randomization)
    - Blood levels of CRP
    - Proportion of patients who experienced adverse events, especially hyperglycaemia, healing impairment within 7 days after surgery
    E.5.2.1Timepoint(s) of evaluation of this end point
    28 days
    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 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) Yes
    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 No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group No
    E.8.1.6Cross over Yes
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    cluster
    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.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned32
    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
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months25
    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 For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2017-04-21. Yes
    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 state1222
    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)
    At the end of the trial the patients will be follow for their medical condition according to the local clinical practice.
    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 Decision2017-09-06
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-09-12
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2019-04-16
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