ID

38075

Descripción

BACKGROUND: Currently, there is no proven pharmacologic treatment for patients with the acute respiratory distress syndrome (ARDS). Great interest remains in the use of corticosteroids for the salvage of patients with severe acute lung injury in the early phase of their disease process, a situation that that has not been evaluated in most published trials. Dexamethasone has never been evaluated in ARDS in a randomized controlled fashion. HYPOTHESIS AND OBJECTIVES: The investigators hypothesize that adjunctive treatment with intravenous dexamethasone of patients with established ARDS might change the pulmonary and systemic inflammatory response and thereby will increase the number of ventilator-free days and will decrease the extremely high overall mortality. Our goal is to examine the effects of dexamethasone on length of duration of mechanical ventilation (assessed by number of ventilator-free days) and on mortality, in patients admitted into a network of Spanish intensive care units (ICUs) who still meet ARDS criteria at 24 hours after ARDS onset.

Palabras clave

Versiones (1)
  1. 15/9/19 15/9/19 -
Titular de derechos de autor

Dr. Negrin University Hospital

Subido en

15 de septiembre de 2019

DOI

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Licencia

Creative Commons BY-NC 3.0
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Dexamethasone for Acute Respiratory Distress Syndrome NCT01731795

Inglés

Eligibility Criteria

1 formularios  
  1. StudyEvent: ODM
    1. Eligibility Criteria
Inclusion Criteria
Descripción

Inclusion Criteria

Alias
UMLS CUI-1
C1512693
Is the participant ≥18 years old?
Descripción

Age

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0001779
Does the participant have acute onset of ARDS, as defined by the American-European Consensus Conference (AECC) criteria for ARDS?
Descripción

American-European Consensus Conference criteria for ARDS: (i) having an initiating clinical condition (pneumonia, aspiration, inhalation injury, sepsis, trauma, acute pancreatitis, etc.; (ii) bilateral infiltrates on frontal chest radiograph; (iii) absence of left atrial hypertension, a pulmonary capillary wedge pressure (PCWP) less than 18 mm Hg, or no clinical signs of left heart failure; (iv) severe hypoxemia (a PaO2/FIO2 <200 mm Hg, regardless of FIO2 or positive end-expiratory pressure (PEEP)

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1276802
UMLS CUI [1,2]
C0035222
UMLS CUI [1,3]
C0683983
UMLS CUI [1,4]
C0243161
Is the participant intubated and mechanically ventilated?
Descripción

Intubation and Mechanical Ventilation

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0021925
UMLS CUI [2]
C0199470
Does the participant have provided signed written informed consent from the patient or the patient's personal legal representative?
Descripción

Informed consent

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0009797
UMLS CUI [1,2]
C1519316
UMLS CUI [1,3]
C0030705
UMLS CUI [2,1]
C0009797
UMLS CUI [2,2]
C1519316
UMLS CUI [2,3]
C0030701
Exclusion Criteria
Descripción

Exclusion Criteria

Alias
UMLS CUI-1
C0680251
Is the participant a woman known to be pregnant or lactating?
Descripción

Pregnant or Lactating

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0043210
UMLS CUI [1,2]
C0032961
UMLS CUI [2,1]
C0043210
UMLS CUI [2,2]
C0006147
Does the participant take part in another experimental treatment protocol (simultaneously)?
Descripción

Other treatment protocol

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0205394
UMLS CUI [1,2]
C1517586
UMLS CUI [1,3]
C0040808
UMLS CUI [1,4]
C0521115
Does the participant have Brain death?
Descripción

Brain death

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0006110
Does the participant have terminal-stage cancer or other terminal disease?
Descripción

Terminal stage cancer or disease

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0205088
UMLS CUI [1,2]
C0006826
UMLS CUI [2,1]
C0205394
UMLS CUI [2,2]
C0679247
Does the participant have do-not-resuscitate orders?
Descripción

Do-not-rescuitate orders

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0079252
Is the participant immune-compromised?
Descripción

Immunocompromised

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0085393
Does the participant receive corticosteroids or immunosuppressive drugs?
Descripción

Corticosteroids or immunosuppressive drugs

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0239126
UMLS CUI [2]
C0021081
Have more than 24 hours had elapsed after initially meeting the AECC ARDS criteria before consent and results of initial standard ventilator settings could be obtained in this participant?
Descripción

24 hours since onset elasped

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C4699705
UMLS CUI [1,2]
C0687676
UMLS CUI [1,3]
C0243161
UMLS CUI [1,4]
C1550543
UMLS CUI [1,5]
C0332152
UMLS CUI [1,6]
C1511481
UMLS CUI [1,7]
C0205265
UMLS CUI [1,8]
C0087153
UMLS CUI [1,9]
C4533435
Does the participant have severe chronic obstructive pulmonary disease (COPD)?
Descripción

COPD

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0205082
UMLS CUI [1,2]
C0024117
Does the participant have congestive heart failure?
Descripción

Congestive Heart Failure

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0018802
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Similar models

Eligibility Criteria

1 formularios
  1. StudyEvent: ODM
    1. Eligibility Criteria
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
Inclusion Criteria
C1512693 (UMLS CUI-1)
Age
Item
Is the participant ≥18 years old?
boolean
C0001779 (UMLS CUI [1])
Acute Respiratory Distress Syndrome
Item
Does the participant have acute onset of ARDS, as defined by the American-European Consensus Conference (AECC) criteria for ARDS?
boolean
C1276802 (UMLS CUI [1,1])
C0035222 (UMLS CUI [1,2])
C0683983 (UMLS CUI [1,3])
C0243161 (UMLS CUI [1,4])
Intubation and Mechanical Ventilation
Item
Is the participant intubated and mechanically ventilated?
boolean
C0021925 (UMLS CUI [1])
C0199470 (UMLS CUI [2])
Informed consent
Item
Does the participant have provided signed written informed consent from the patient or the patient's personal legal representative?
boolean
C0009797 (UMLS CUI [1,1])
C1519316 (UMLS CUI [1,2])
C0030705 (UMLS CUI [1,3])
C0009797 (UMLS CUI [2,1])
C1519316 (UMLS CUI [2,2])
C0030701 (UMLS CUI [2,3])
Item Group
Exclusion Criteria
C0680251 (UMLS CUI-1)
Pregnant or Lactating
Item
Is the participant a woman known to be pregnant or lactating?
boolean
C0043210 (UMLS CUI [1,1])
C0032961 (UMLS CUI [1,2])
C0043210 (UMLS CUI [2,1])
C0006147 (UMLS CUI [2,2])
Other treatment protocol
Item
Does the participant take part in another experimental treatment protocol (simultaneously)?
boolean
C0205394 (UMLS CUI [1,1])
C1517586 (UMLS CUI [1,2])
C0040808 (UMLS CUI [1,3])
C0521115 (UMLS CUI [1,4])
Brain death
Item
Does the participant have Brain death?
boolean
C0006110 (UMLS CUI [1])
Terminal stage cancer or disease
Item
Does the participant have terminal-stage cancer or other terminal disease?
boolean
C0205088 (UMLS CUI [1,1])
C0006826 (UMLS CUI [1,2])
C0205394 (UMLS CUI [2,1])
C0679247 (UMLS CUI [2,2])
Do-not-rescuitate orders
Item
Does the participant have do-not-resuscitate orders?
boolean
C0079252 (UMLS CUI [1])
Immunocompromised
Item
Is the participant immune-compromised?
boolean
C0085393 (UMLS CUI [1])
Corticosteroids or immunosuppressive drugs
Item
Does the participant receive corticosteroids or immunosuppressive drugs?
boolean
C0239126 (UMLS CUI [1])
C0021081 (UMLS CUI [2])
24 hours since onset elasped
Item
Have more than 24 hours had elapsed after initially meeting the AECC ARDS criteria before consent and results of initial standard ventilator settings could be obtained in this participant?
boolean
C4699705 (UMLS CUI [1,1])
C0687676 (UMLS CUI [1,2])
C0243161 (UMLS CUI [1,3])
C1550543 (UMLS CUI [1,4])
C0332152 (UMLS CUI [1,5])
C1511481 (UMLS CUI [1,6])
C0205265 (UMLS CUI [1,7])
C0087153 (UMLS CUI [1,8])
C4533435 (UMLS CUI [1,9])
COPD
Item
Does the participant have severe chronic obstructive pulmonary disease (COPD)?
boolean
C0205082 (UMLS CUI [1,1])
C0024117 (UMLS CUI [1,2])
Congestive Heart Failure
Item
Does the participant have congestive heart failure?
boolean
C0018802 (UMLS CUI [1])
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