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   43871   clinical trials with a EudraCT protocol, of which   7290   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:2021-002816-30
    Sponsor's Protocol Code Number:01072021
    National Competent Authority:Denmark - DHMA
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2021-09-03
    Trial 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 ConcernedDenmark - DHMA
    A.2EudraCT number2021-002816-30
    A.3Full title of the trial
    Individualised perioperative blood pressure and fluid therapy in oesophagectomy -
    Study protocol for a prospective randomised controlled trial
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Individualised perioperative blood pressure and fluid therapy in oe-sophagectomy -
    Study protocol for a prospective randomised controlled trial
    A.4.1Sponsor's protocol code number01072021
    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 SponsorDepartment of Anaesthesiology, Aarhus University Hospital
    B.1.3.4CountryDenmark
    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 Anaesthesiology, Aarhus University Hospital
    B.4.2CountryDenmark
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationDepartment of Anaesthesiology, Aarhus University Hospital
    B.5.2Functional name of contact pointDepartment of Anaesthesiology
    B.5.3 Address:
    B.5.3.1Street AddressPalle Juul-Jensens Blvd. 161
    B.5.3.2Town/ cityAarhus N
    B.5.3.3Post code8200
    B.5.3.4CountryDenmark
    B.5.6E-mailpeter.juhl-olsen@clin.au.dk
    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 Noradrenalin SAD
    D.2.1.1.2Name of the Marketing Authorisation holderAmgros I/S Dampfærgevej 22 Postbox 2593 2100 København Ø
    D.2.1.2Country which granted the Marketing AuthorisationDenmark
    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 nameNoradrenalin SAD
    D.3.2Product code C01CA03
    D.3.4Pharmaceutical form Infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    Infusion (Noncurrent)
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNNoradrenaline SAD
    D.3.9.3Other descriptive nameNORADRENALINE HYDROCHLORIDE
    D.3.9.4EV Substance CodeSUB03456MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1
    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 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 Dobutrex
    D.2.1.1.2Name of the Marketing Authorisation holderSTADA Nordic ApS Marielundvej 46A 2730 Herlev
    D.2.1.2Country which granted the Marketing AuthorisationDenmark
    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 IMPInfusion (Noncurrent)
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNDOBUTAMINE
    D.3.9.1CAS number 34368-04-2
    D.3.9.4EV Substance CodeSUB06343MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/l milligram(s)/litre
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number1 to 2000
    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 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
    Oesophagectomy
    E.1.1.1Medical condition in easily understood language
    The surgical removal of part of the oesophagus in the case of cancer or other disease.
    Fjernelse af et stykke eller hele spiserøret i tilfælde af spiserørskræft
    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 10030215
    E.1.2Term Oesophagectomy
    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
    Version 2.1
    Date: 03.06.22

    To investigate the impact of goal directed fluid therapy (GDT) vs. standard fluid/vasoactive therapy in the perioperative phase of oesophagectomy on comprehensive complication index at 30 days
    E.2.2Secondary objectives of the trial
    For all secondary endpoints see E.5.2 Secondary end point(s).
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Version 2.1
    Date: 03.06.22

    Title
    The effects of pneumoperitoneum and one lung ventilation on stroke volume variation (SVV) during laparoscopic procedures

    Hypothesis
    The induction of pneumoperitoneum increases SVV and PPV. SVV is dependent on the sidedness of OLV.

    Aims
    1. To delineate the effects of the increased abdominal pressure induced by pneumoperitoneum on SVV and determine whether this impact on SVV is sufficient to create a false positive indication of fluid responsiveness (>10%).
    2. To demask effects of pneumoperitoneum on pressures in related bodily compartments at the venous, arterial and respiratory level using a GAM.
    3. To describe the effects of OLV on SVV and PPV
    E.3Principal inclusion criteria
    • Scheduled for elective esophagectomy at the Department of Thoracic Surgery, Aarhus University Hospital, comprising of:
    o Esophagectomy with gastric pull-up
    o Distal esophagectomy with total gastrectomy and other reconstructive procedure (duodenum eller colon)
    o Total esophagectomy med colonanastomosis in the neck area
    • Age ≥ 18 years
    • Scheduled for laparoscopy (and not open surgery) (study II only)
    E.4Principal exclusion criteria
    • Lack of consent
    • Women of childbearing age without negative pregnancy test
    • Known allergy or intolerance to any of the included drugs
    • Cardiac pacemaker
    • Chronic- or paroxysmal atrial fibrillation
    • Left ventricular ejection fraction <40% (if known)
    • Right ventricular TAPSE < 16mm (if known)
    • Cardiac pacemaker
    • Chronic- or paroxysmal atrial fibrillation
    • Left ventricular ejection fraction <40% (if known)
    • Right ventricular TAPSE < 16mm (if known)
    E.5 End points
    E.5.1Primary end point(s)
    Version 2.1
    Date: 03.06.22

    The primary endpoint is overall morbidity using the CCI calculated from www.assessurgery.com
    E.5.1.1Timepoint(s) of evaluation of this end point
    Day 30 post-operative
    E.5.2Secondary end point(s)
    Within anaesthesia time
    - Anaesthetics used
    - Vasoactive medication
    - Systemic blood pressure (systolic- and diastolic blood pressure every 20 minutes – mmHg)
    - Fluids: colloids (mL), crystalloids (mL)
    - Estimated blood loss (mL)
    - Blood transfusion (type and mL)
    - Urine output (mL)
    - Net fluid balance from the start of anaesthesia until the end of anaesthesia (mL)
    - Net fluid balance from the start of anaesthesia until 24 hours after start of anaesthesia
    - One-lung ventilation time and volume (mins and mL)
    - Laparoscopic inflation time (no & min)
    - Open thorax (open surgery only) (no & min)
    - Thoracoscopic surgery time (only scopic surgery in thorax) (no & min)
    o CO (continuous – L/min)
    o SVV (continuous - %)
    o PPV (continuous - %)
    o HPI (continuous – 1-100)
    o Mean, systolic and diastolic blood pressures (continuous – mmHg)
    - Timing of surgeon’s hands-on that may influence dynamic haemodynamic variables
    - Peritoneal pressure (from the laparoscopy inflation device) is recorded manually during surgery

    In the ICU
    - Opioids used (morphine (mg), fentanyl (ug), alfentanil (mg), oxycodone (mg).
    - Epidural dose of. Breivik’s mixture25 (bupivacaine 0.1 mg/mL, fentanyl 2 ug/mL, adrenaline 2 ug/mL) mL
    - Systemic blood pressure (systolic- and diastolic blood pressure every 20 minutes – mmHg)
    o CO (continuous – L/min)
    o PPV (continuous - %)
    o HPI (continuous – 1-100)
    o Mean, systolic and diastolic blood pressures (continuous – mmHg)
    - Colloids (mL)
    - Crystalloids (mL)
    - Sum of colloids & crystalloids (mL)
    - Blood transfusion (type and mL)
    - Urine output (mL)
    - New onset arrhythmia (atrial fibrillation/atrial flutter (no), ventricular tachycardia (no)
    - Troponin I (day 1 morning)

    Ultrasonographic muscle mass assessment which will be compared to CCI at 30 and 90 days.
     Quadriceps depth (cm) day 1 and 90
     Rectus femoris cross sectional area (cm2) day 1 and 90
    Variables from preoperative CT-scans
    o Average of left and right psoas muscle area at the level of L4 (cm2)

    Complications: temporally defined as occurring within 30 and 90 days of surgery (date minus surgical date)
    - Reoperation (no): defined as interventions requiring general anaesthesia
    - Anastomotic leak (no and divided into mild, moderate and severe as defined by European Perioperative Clinical Outcome (EPCO)30
    - Delirium (no of days): As defined by attending physician
    - Pneumonia (no) as defined by EPCO
    - Atelectasis
    - Pneumothorax (Drain in situ 8 days for (If no anastomotic leakage on day 8)) (no)
    - Pneumothorax (requiring renewed drainage) (no)
    - Pleural Effusion
    - Acute Lung Injury (ALI) (yes/no) definition:
    1. acute onset within a few days from the insult
    2. non-cardiogenic pulmonary oedema
    3. diffuse bilateral infiltrates
    4. PaO2/FiO2 < 300 mmHg
    - Acute Respiratory Distress Syndrome (ARDS) (yes/no)
    - Overhydration defined as the clinician opting to treat weight gain with or without respiratory symptoms with diuretics
    - Pulmonary embolism (no) as defined by radiology
    - Non-fatal cardiac arrest as defined by EPCO
    - Acute myocardial infarction (no) as defined by EPCO
    - Cardiogenic pulmonary oedema (no and divided into mild, moderate and severe) (EPCO)
    - New onset arrythmia (no and divided into mild, moderate and severe) (EPCO)
    - Major Adverse Cardiac Events (MACE) (no) as defined by EPCO
    - Acute kidney injury within 7 days of surgery (no total and divided in categories) – as defined with Kidney Disease Improving Global Outcomes (KDIGO) criteria (only changes in creatinine) (EPCO)
    - Paralytic ileus as defined by EPCO
    - Infection, superficial (no) as defined by EPCO
    - Infection, deep (no) as defined by EPCO
    - Urinary tract infection (no) as defined by EPCO
    - Infection with unknown focus (no and divided into mild, moderate and severe) (EPCO)
    - Chyle leak, conservative treatment (no)
    o The following diagnostic criteria must be met for chyle leakage to be diagnosed: triglycerides >110 mg/dL, cholesterol <200 mg/dL, and presence of chylomicrons. However, the above criteria may not be met when the patient is fasting, and the drainage color can be serous with a normal level of triglycerides
    - Chyle leak, operative treatment (no)
    - Oesophageal stricture, conservative treatment (no)
    - Oesophageal stricture, operative treatment (no)
    - Deep vein thrombosis as diagnosed by ultrasound (no)
    - Central venous line infection (no)
    - Jejunostomy infection (no)
    - Vocal cord palsy (no)
    - All-cause mortality (90 days from date of surgery. Defined as date of death minus date of surgery)
    - Postoperative intubation (no and hours)
    - Creatinine before surgery and on day 1, 3 and 7
    E.5.2.1Timepoint(s) of evaluation of this end point
    Day 30 and 90 post-operative
    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 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 Yes
    E.8.2.3.1Comparator description
    Perioperative fluid therapy according to local guidelines
    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
    90 days after inclusion of the last patient or if any of the prespecified stopping rules are met (see full protocol)
    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: 70
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 30
    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 state100
    F.4.2 For a multinational trial
    F.4.2.2In the whole clinical trial 100
    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)
    Participants receive treatment according to local guidelines when the intervention period ends at 07:00 AM the first post-operative day
    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 Decision2021-11-02
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-11-12
    P. End of Trial
    P.End of Trial StatusOngoing
    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-Thu May 02 01:48:28 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA