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ID

37370

Beskrivning

Study ID: 111592 Clinical Study ID: 111592 Study Title: A Randomized, Double-blind, Placebo-controlled, Doseescalation Study to Assess the Anti-inflammatory Activity, Efficacy, and Safety of Intravenous SB-681323 in Subjects at Risk for Development of Acute Lung Injury or ARDS Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00996840 See https://clinicaltrials.gov/ct2/show/NCT00996840 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 2 Study Recruitment Status: Completed Generic Name: Placebo, SB-681323 Trade Name: N/A Study Indication: Lung Injury, Acute The primary objective of this phase 2 trial is to evaluate the safety and tolerability of intravenous dilmapimod/SB-681323 given in escalating dosages and over different intervals for three days in trauma patients at risk for the development of ALI or ARDS. This study consists of Screening, infusion of dilmapimod/SB-681323 on days 1-3, examination/sampling up to early day 5 (denoted as "Day 3 - 48 hrs") and a Follow-up on day 7. There are four cohorts, cohorts 1 and 3 receive the medication (or placebo) infusion over 4 hours, cohorts 2 and 4 over 24 hours. This form contains the participant's vital signs including ventilator settings, which are assessed at Screening, on Day 1 at 4 hrs (cohorts 1 and 3 only), Day 2 at 0 hrs, Day 3 at 0 hrs, Day 3 at 24 hrs (i.e. Day 4 at 0 hrs), and Follow-Up (for all cohorts, except for Day 1 at 4 hrs). This form can also be used for any repeat/unscheduled assessment of vital signs.

Länk

https://clinicaltrials.gov/ct2/show/NCT00996840

Nyckelord

Versioner (1)
  1. 20.07.19 20.07.19 -
Rättsinnehavare

GlaxoSmithKline

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20. Juli 2019

DOI

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Creative Commons BY-NC 3.0
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    SB-681323 in ALI/ARDS risk patients - NCT00996840

    Engelsk

    Vitals Signs

    1 Formulär  
    1. StudyEvent: ODM
      1. Vitals Signs
    Administrative Data
    Beskrivning

    Administrative Data

    Alias
    UMLS CUI-1
    C1320722
    Subject ID
    Beskrivning

    Subject ID

    Datatyp

    integer

    Alias
    UMLS CUI [1]
    C2348585
    Cohort
    Beskrivning

    Cohort

    Datatyp

    integer

    Alias
    UMLS CUI [1]
    C0599755
    Type of Visit
    Beskrivning

    Please select options 1, 6 or 7 as visit type, and select scheduled time (options 2 to 5) for planned visits (i.e. time after start of dose). Day 1, 4 hrs is only applicable for Cohorts 1 and 3, all others for all cohorts.

    Datatyp

    integer

    Alias
    UMLS CUI [1]
    C3641100
    Dosing Date and Time
    Beskrivning

    Dosing Date and Time

    Alias
    UMLS CUI-1
    C0178602
    UMLS CUI-2
    C1264639
    Start Dosing date/time
    Beskrivning

    if applicable

    Datatyp

    datetime

    Alias
    UMLS CUI [1,1]
    C3897500
    UMLS CUI [1,2]
    C3469597
    UMLS CUI [1,3]
    C0304229
    Vital Signs
    Beskrivning

    Vital Signs

    Alias
    UMLS CUI-1
    C0518766
    Actual date/time
    Beskrivning

    Date/time

    Datatyp

    datetime

    Alias
    UMLS CUI [1]
    C1264639
    Height
    Beskrivning

    Height

    Datatyp

    integer

    Måttenheter
    • cm
    Alias
    UMLS CUI [1]
    C0005890
    cm
    Weight
    Beskrivning

    Weight

    Datatyp

    float

    Måttenheter
    • kg
    Alias
    UMLS CUI [1]
    C0005910
    kg
    Body mass index
    Beskrivning

    calculated from height and weight

    Datatyp

    float

    Måttenheter
    • kg/m2
    Alias
    UMLS CUI [1]
    C1305855
    kg/m2
    Blood pressure systolic
    Beskrivning

    if done

    Datatyp

    integer

    Måttenheter
    • mmHg
    Alias
    UMLS CUI [1]
    C0871470
    mmHg
    Blood pressure diastolic
    Beskrivning

    if done

    Datatyp

    integer

    Måttenheter
    • mmHg
    Alias
    UMLS CUI [1]
    C0428883
    mmHg
    Heart Rate
    Beskrivning

    if done

    Datatyp

    integer

    Måttenheter
    • beats/min
    Alias
    UMLS CUI [1]
    C0018810
    beats/min
    Oxygen Administration
    Beskrivning

    Oxygen Administration

    Alias
    UMLS CUI-1
    C0184633
    Method of Oxygen delivery
    Beskrivning

    If ventilator, give details in following questions

    Datatyp

    text

    Alias
    UMLS CUI [1]
    C0809836
    Mode of Ventilation
    Beskrivning

    if applicable if 6 = Other, please specify

    Datatyp

    integer

    Alias
    UMLS CUI [1]
    C0808387
    Other mode of Ventilation specification
    Beskrivning

    if applicable

    Datatyp

    text

    Alias
    UMLS CUI [1,1]
    C0205394
    UMLS CUI [1,2]
    C0808387
    UMLS CUI [1,3]
    C2348235
    Tidal Volume (mL) applicable?
    Beskrivning

    If yes, give value in next question.

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0040210
    UMLS CUI [1,2]
    C1706839
    Tidal Volume
    Beskrivning

    if applicable

    Datatyp

    float

    Måttenheter
    • mL
    Alias
    UMLS CUI [1]
    C0040210
    mL
    Minute Volume determinable?
    Beskrivning

    If yes, give value in next question.

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0428679
    UMLS CUI [1,2]
    C1148554
    UMLS CUI [1,3]
    C0332149
    Minute Volume
    Beskrivning

    if determinable

    Datatyp

    float

    Måttenheter
    • L
    Alias
    UMLS CUI [1]
    C0428679
    L
    Positive End Expiratory Pressure (PEEP) determinable?
    Beskrivning

    If yes, give value in next question.

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0807495
    UMLS CUI [1,2]
    C1148554
    UMLS CUI [1,3]
    C0332149
    Positive End Expiratory Pressure (PEEP)
    Beskrivning

    if determinable

    Datatyp

    integer

    Måttenheter
    • cm H2O
    Alias
    UMLS CUI [1]
    C0032740
    cm H2O
    Peak Ventilatory Pressure determinable
    Beskrivning

    If yes, give value in next question.

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0232021C1148554
    UMLS CUI [1,2]
    C0332149
    Peak Ventilatory Pressure
    Beskrivning

    if determinable

    Datatyp

    integer

    Måttenheter
    • cm H2O
    Alias
    UMLS CUI [1]
    C0232021
    cm H2O
    Plateau Ventilatory Pressure determinable
    Beskrivning

    If yes, give value in next question.

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0445176
    UMLS CUI [1,2]
    C1148554
    UMLS CUI [1,3]
    C0332149
    Plateau Ventilatory Pressure
    Beskrivning

    if determinable

    Datatyp

    integer

    Måttenheter
    • cm H2O
    Alias
    UMLS CUI [1]
    C0445176
    cm H2O
    Oxygen Requirement (FiO2)
    Beskrivning

    in Percent or Litre/min (see next item)

    Datatyp

    float

    Alias
    UMLS CUI [1,1]
    C1514873
    UMLS CUI [1,2]
    C4534306
    Oxygen Requirement (FiO2) units
    Beskrivning

    Oxygen Requirement units

    Datatyp

    integer

    Alias
    UMLS CUI [1,1]
    C1514873
    UMLS CUI [1,2]
    C4534306
    UMLS CUI [2]
    C1519795
    Pulse Oximeter
    Beskrivning

    Pulse Oximeter

    Alias
    UMLS CUI-1
    C0034108
    Oxygen Saturation (SpO2)
    Beskrivning

    Oxygen Saturation

    Datatyp

    integer

    Måttenheter
    • %
    Alias
    UMLS CUI [1]
    C0523807
    %
    ABG
    Beskrivning

    ABG

    Alias
    UMLS CUI-1
    C2598151
    ABG PaO2 done?
    Beskrivning

    ABG PaO2 done

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C2237101
    UMLS CUI [1,2]
    C0884358
    ABG PaO2
    Beskrivning

    if done

    Datatyp

    integer

    Måttenheter
    • mmHg
    Alias
    UMLS CUI [1]
    C2237101
    mmHg
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    Similar models

    Vitals Signs

    1 Formulär
    1. StudyEvent: ODM
      1. Vitals Signs
    Name
    Typ
    Description | Question | Decode (Coded Value)
    Datatyp
    Alias
    Item Group
    Administrative Data
    C1320722 (UMLS CUI-1)
    Subject ID
    Item
    Subject ID
    integer
    C2348585 (UMLS CUI [1])
    Item
    Cohort
    integer
    C0599755 (UMLS CUI [1])
    Cohort
    Code List
    Cohort
    CL Item
    Cohort 1 (1)
    CL Item
    Cohort 2 (2)
    CL Item
    Cohort 3 (3)
    CL Item
    Cohort 4 (4)
    Item
    Type of Visit
    integer
    C3641100 (UMLS CUI [1])
    Type of Visit
    Code List
    Type of Visit
    CL Item
    Screening (1)
    CL Item
    Day 1, 4 hrs (2)
    CL Item
    Day 2, 0 hrs (3)
    CL Item
    Day 3, 0 hrs (4)
    CL Item
    Day 3, 24 hrs (5)
    CL Item
    Follow-up (6)
    CL Item
    Repeat Assessment (7)
    Item Group
    Dosing Date and Time
    C0178602 (UMLS CUI-1)
    C1264639 (UMLS CUI-2)
    Start Dosing date/time
    Item
    Start Dosing date/time
    datetime
    C3897500 (UMLS CUI [1,1])
    C3469597 (UMLS CUI [1,2])
    C0304229 (UMLS CUI [1,3])
    Item Group
    Vital Signs
    C0518766 (UMLS CUI-1)
    Date/time
    Item
    Actual date/time
    datetime
    C1264639 (UMLS CUI [1])
    Height
    Item
    Height
    integer
    C0005890 (UMLS CUI [1])
    Weight
    Item
    Weight
    float
    C0005910 (UMLS CUI [1])
    Body mass index
    Item
    Body mass index
    float
    C1305855 (UMLS CUI [1])
    Blood pressure systolic
    Item
    Blood pressure systolic
    integer
    C0871470 (UMLS CUI [1])
    Blood pressure diastolic
    Item
    Blood pressure diastolic
    integer
    C0428883 (UMLS CUI [1])
    Heart Rate
    Item
    Heart Rate
    integer
    C0018810 (UMLS CUI [1])
    Item Group
    Oxygen Administration
    C0184633 (UMLS CUI-1)
    Item
    Method of Oxygen delivery
    text
    C0809836 (UMLS CUI [1])
    Method of Oxygen delivery
    Code List
    Method of Oxygen delivery
    CL Item
    Room Air (Room Air)
    CL Item
    Nasal Prongs (Nasal Prongs)
    CL Item
    Face Mask (Face Mask)
    CL Item
    Ventilator (Ventilator)
    Item
    Mode of Ventilation
    integer
    C0808387 (UMLS CUI [1])
    Mode of Ventilation
    Code List
    Mode of Ventilation
    CL Item
    A/C (1)
    CL Item
    IMV/sIMV (2)
    CL Item
    Pressure controlled ventilation (3)
    CL Item
    Pressure support (4)
    CL Item
    Non-invasive positive pressure ventilation (5)
    CL Item
    Other (6)
    Other ventilation mode specification
    Item
    Other mode of Ventilation specification
    text
    C0205394 (UMLS CUI [1,1])
    C0808387 (UMLS CUI [1,2])
    C2348235 (UMLS CUI [1,3])
    Tidal Volume applicable
    Item
    Tidal Volume (mL) applicable?
    boolean
    C0040210 (UMLS CUI [1,1])
    C1706839 (UMLS CUI [1,2])
    Tidal Volume
    Item
    Tidal Volume
    float
    C0040210 (UMLS CUI [1])
    Minute Volume determinable
    Item
    Minute Volume determinable?
    boolean
    C0428679 (UMLS CUI [1,1])
    C1148554 (UMLS CUI [1,2])
    C0332149 (UMLS CUI [1,3])
    Minute Volume
    Item
    Minute Volume
    float
    C0428679 (UMLS CUI [1])
    PEEP determinable
    Item
    Positive End Expiratory Pressure (PEEP) determinable?
    boolean
    C0807495 (UMLS CUI [1,1])
    C1148554 (UMLS CUI [1,2])
    C0332149 (UMLS CUI [1,3])
    PEEP
    Item
    Positive End Expiratory Pressure (PEEP)
    integer
    C0032740 (UMLS CUI [1])
    Peak Ventilatory Pressure determinable
    Item
    Peak Ventilatory Pressure determinable
    boolean
    C0232021C1148554 (UMLS CUI [1,1])
    C0332149 (UMLS CUI [1,2])
    Peak Ventilatory Pressure
    Item
    Peak Ventilatory Pressure
    integer
    C0232021 (UMLS CUI [1])
    Plateau Ventilatory Pressure determinable
    Item
    Plateau Ventilatory Pressure determinable
    boolean
    C0445176 (UMLS CUI [1,1])
    C1148554 (UMLS CUI [1,2])
    C0332149 (UMLS CUI [1,3])
    Plateau Ventilatory Pressure
    Item
    Plateau Ventilatory Pressure
    integer
    C0445176 (UMLS CUI [1])
    Oxygen Requirement
    Item
    Oxygen Requirement (FiO2)
    float
    C1514873 (UMLS CUI [1,1])
    C4534306 (UMLS CUI [1,2])
    Item
    Oxygen Requirement (FiO2) units
    integer
    C1514873 (UMLS CUI [1,1])
    C4534306 (UMLS CUI [1,2])
    C1519795 (UMLS CUI [2])
    Oxygen Requirement units
    Code List
    Oxygen Requirement (FiO2) units
    CL Item
    Percent (1)
    CL Item
    Litre per minute (2)
    Item Group
    Pulse Oximeter
    C0034108 (UMLS CUI-1)
    Oxygen Saturation
    Item
    Oxygen Saturation (SpO2)
    integer
    C0523807 (UMLS CUI [1])
    Item Group
    ABG
    C2598151 (UMLS CUI-1)
    ABG PaO2 done
    Item
    ABG PaO2 done?
    boolean
    C2237101 (UMLS CUI [1,1])
    C0884358 (UMLS CUI [1,2])
    ABG PaO2
    Item
    ABG PaO2
    integer
    C2237101 (UMLS CUI [1])
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