ID

37370

Description

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.

Link

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

Keywords

Versions (1)
  1. 7/20/19 7/20/19 -
Copyright Holder

GlaxoSmithKline

Uploaded on

July 20, 2019

DOI

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License

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

English

Vitals Signs

1 forms  
  1. StudyEvent: ODM
    1. Vitals Signs
Administrative Data
Description

Administrative Data

Alias
UMLS CUI-1
C1320722
Subject ID
Description

Subject ID

Data type

integer

Alias
UMLS CUI [1]
C2348585
Cohort
Description

Cohort

Data type

integer

Alias
UMLS CUI [1]
C0599755
Type of Visit
Description

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.

Data type

integer

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

Dosing Date and Time

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

if applicable

Data type

datetime

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

Vital Signs

Alias
UMLS CUI-1
C0518766
Actual date/time
Description

Date/time

Data type

datetime

Alias
UMLS CUI [1]
C1264639
Height
Description

Height

Data type

integer

Measurement units
  • cm
Alias
UMLS CUI [1]
C0005890
cm
Weight
Description

Weight

Data type

float

Measurement units
  • kg
Alias
UMLS CUI [1]
C0005910
kg
Body mass index
Description

calculated from height and weight

Data type

float

Measurement units
  • kg/m2
Alias
UMLS CUI [1]
C1305855
kg/m2
Blood pressure systolic
Description

if done

Data type

integer

Measurement units
  • mmHg
Alias
UMLS CUI [1]
C0871470
mmHg
Blood pressure diastolic
Description

if done

Data type

integer

Measurement units
  • mmHg
Alias
UMLS CUI [1]
C0428883
mmHg
Heart Rate
Description

if done

Data type

integer

Measurement units
  • beats/min
Alias
UMLS CUI [1]
C0018810
beats/min
Oxygen Administration
Description

Oxygen Administration

Alias
UMLS CUI-1
C0184633
Method of Oxygen delivery
Description

If ventilator, give details in following questions

Data type

text

Alias
UMLS CUI [1]
C0809836
Mode of Ventilation
Description

if applicable if 6 = Other, please specify

Data type

integer

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

if applicable

Data type

text

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

If yes, give value in next question.

Data type

boolean

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

if applicable

Data type

float

Measurement units
  • mL
Alias
UMLS CUI [1]
C0040210
mL
Minute Volume determinable?
Description

If yes, give value in next question.

Data type

boolean

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

if determinable

Data type

float

Measurement units
  • L
Alias
UMLS CUI [1]
C0428679
L
Positive End Expiratory Pressure (PEEP) determinable?
Description

If yes, give value in next question.

Data type

boolean

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

if determinable

Data type

integer

Measurement units
  • cm H2O
Alias
UMLS CUI [1]
C0032740
cm H2O
Peak Ventilatory Pressure determinable
Description

If yes, give value in next question.

Data type

boolean

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

if determinable

Data type

integer

Measurement units
  • cm H2O
Alias
UMLS CUI [1]
C0232021
cm H2O
Plateau Ventilatory Pressure determinable
Description

If yes, give value in next question.

Data type

boolean

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

if determinable

Data type

integer

Measurement units
  • cm H2O
Alias
UMLS CUI [1]
C0445176
cm H2O
Oxygen Requirement (FiO2)
Description

in Percent or Litre/min (see next item)

Data type

float

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

Oxygen Requirement units

Data type

integer

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

Pulse Oximeter

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

Oxygen Saturation

Data type

integer

Measurement units
  • %
Alias
UMLS CUI [1]
C0523807
%
ABG
Description

ABG

Alias
UMLS CUI-1
C2598151
ABG PaO2 done?
Description

ABG PaO2 done

Data type

boolean

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

if done

Data type

integer

Measurement units
  • mmHg
Alias
UMLS CUI [1]
C2237101
mmHg
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Similar models

Vitals Signs

1 forms
  1. StudyEvent: ODM
    1. Vitals Signs
Name
Type
Description | Question | Decode (Coded Value)
Data type
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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