ID

32343

Description

Clinical Factors Associated With the Development of Severe Sepsis in Patients Being Treated for Acute Myeloid Leukemia; ODM derived from: https://clinicaltrials.gov/show/NCT00806325

Link

https://clinicaltrials.gov/show/NCT00806325

Keywords

Versions (1)
  1. 10/27/18 10/27/18 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

October 27, 2018

DOI

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License

Creative Commons BY 4.0
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Eligibility Sepsis NCT00806325

English

Eligibility Sepsis NCT00806325

1 forms  
  1. StudyEvent: Eligibility
    1. Eligibility Sepsis NCT00806325
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
diagnosis of acute myeloid leukemia
Description

Leukemia, Myelocytic, Acute

Data type

boolean

Alias
UMLS CUI [1]
C0023467
age ≥ 18 years of age
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
plans to receive chemotherapy as an inpatient and remain inpatient until hematologic recovery as determined by the primary treating physician
Description

Inpatient | Chemotherapy Planned | Inpatient Until Recovery Hematologic

Data type

boolean

Alias
UMLS CUI [1]
C0021562
UMLS CUI [2,1]
C0392920
UMLS CUI [2,2]
C1301732
UMLS CUI [3,1]
C0021562
UMLS CUI [3,2]
C1720302
UMLS CUI [3,3]
C2004454
UMLS CUI [3,4]
C0205488
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
subject is unlikely to survive > 3 months with treatment
Description

Life Expectancy

Data type

boolean

Alias
UMLS CUI [1]
C0023671
current diagnosis of severe sepsis
Description

Severe Sepsis

Data type

boolean

Alias
UMLS CUI [1]
C1719672
subject or surrogate is unable to give informed consent
Description

Informed Consent Unable | Patient Representative Informed Consent Unable

Data type

boolean

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C1299582
UMLS CUI [2,1]
C0030701
UMLS CUI [2,2]
C0021430
UMLS CUI [2,3]
C1299582
subject is incarcerated
Description

Study Subject In prison

Data type

boolean

Alias
UMLS CUI [1,1]
C0681850
UMLS CUI [1,2]
C0392751
patient's family, physician, or both not in favor of endotracheal intubation or mechanical ventilation for any length of time or the presence of an advanced directive to withhold the same.
Description

Patient Family Endotracheal Intubation Unfavorable | Physician Endotracheal Intubation Unfavorable | Patient Family Mechanical ventilation Unfavorable | Physician Mechanical ventilation Unfavorable

Data type

boolean

Alias
UMLS CUI [1,1]
C0030705
UMLS CUI [1,2]
C0015576
UMLS CUI [1,3]
C0021932
UMLS CUI [1,4]
C3640815
UMLS CUI [2,1]
C0031831
UMLS CUI [2,2]
C0021932
UMLS CUI [2,3]
C3640815
UMLS CUI [3,1]
C0030705
UMLS CUI [3,2]
C0015576
UMLS CUI [3,3]
C0199470
UMLS CUI [3,4]
C3640815
UMLS CUI [4,1]
C0031831
UMLS CUI [4,2]
C0199470
UMLS CUI [4,3]
C3640815
subject currently requiring mechanical ventilation
Description

Mechanical ventilation Required

Data type

boolean

Alias
UMLS CUI [1,1]
C0199470
UMLS CUI [1,2]
C1514873
subject with current diagnosis of acute lung injury or ards (bilateral infiltrates on chest x-ray and pf ratio< 300 with no evidence of left atrial hypertension)
Description

Lung Injury | Respiratory Distress Syndrome, Adult | Bilateral pulmonary infiltrates Chest X-ray | PaO2/FiO2 ratio | Left atrium Hypertension Absent

Data type

boolean

Alias
UMLS CUI [1]
C0273115
UMLS CUI [2]
C0035222
UMLS CUI [3,1]
C2939072
UMLS CUI [3,2]
C0039985
UMLS CUI [4]
C4087239
UMLS CUI [5,1]
C0225860
UMLS CUI [5,2]
C0020538
UMLS CUI [5,3]
C0332197
subject has received chemotherapy for the treatment of aml > 96 hours ago.
Description

Chemotherapy AML

Data type

boolean

Alias
UMLS CUI [1,1]
C0392920
UMLS CUI [1,2]
C0023467
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Similar models

Eligibility Sepsis NCT00806325

1 forms
  1. StudyEvent: Eligibility
    1. Eligibility Sepsis NCT00806325
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Leukemia, Myelocytic, Acute
Item
diagnosis of acute myeloid leukemia
boolean
C0023467 (UMLS CUI [1])
Age
Item
age ≥ 18 years of age
boolean
C0001779 (UMLS CUI [1])
Inpatient | Chemotherapy Planned | Inpatient Until Recovery Hematologic
Item
plans to receive chemotherapy as an inpatient and remain inpatient until hematologic recovery as determined by the primary treating physician
boolean
C0021562 (UMLS CUI [1])
C0392920 (UMLS CUI [2,1])
C1301732 (UMLS CUI [2,2])
C0021562 (UMLS CUI [3,1])
C1720302 (UMLS CUI [3,2])
C2004454 (UMLS CUI [3,3])
C0205488 (UMLS CUI [3,4])
Item Group
C0680251 (UMLS CUI)
Life Expectancy
Item
subject is unlikely to survive > 3 months with treatment
boolean
C0023671 (UMLS CUI [1])
Severe Sepsis
Item
current diagnosis of severe sepsis
boolean
C1719672 (UMLS CUI [1])
Informed Consent Unable | Patient Representative Informed Consent Unable
Item
subject or surrogate is unable to give informed consent
boolean
C0021430 (UMLS CUI [1,1])
C1299582 (UMLS CUI [1,2])
C0030701 (UMLS CUI [2,1])
C0021430 (UMLS CUI [2,2])
C1299582 (UMLS CUI [2,3])
Study Subject In prison
Item
subject is incarcerated
boolean
C0681850 (UMLS CUI [1,1])
C0392751 (UMLS CUI [1,2])
Patient Family Endotracheal Intubation Unfavorable | Physician Endotracheal Intubation Unfavorable | Patient Family Mechanical ventilation Unfavorable | Physician Mechanical ventilation Unfavorable
Item
patient's family, physician, or both not in favor of endotracheal intubation or mechanical ventilation for any length of time or the presence of an advanced directive to withhold the same.
boolean
C0030705 (UMLS CUI [1,1])
C0015576 (UMLS CUI [1,2])
C0021932 (UMLS CUI [1,3])
C3640815 (UMLS CUI [1,4])
C0031831 (UMLS CUI [2,1])
C0021932 (UMLS CUI [2,2])
C3640815 (UMLS CUI [2,3])
C0030705 (UMLS CUI [3,1])
C0015576 (UMLS CUI [3,2])
C0199470 (UMLS CUI [3,3])
C3640815 (UMLS CUI [3,4])
C0031831 (UMLS CUI [4,1])
C0199470 (UMLS CUI [4,2])
C3640815 (UMLS CUI [4,3])
Mechanical ventilation Required
Item
subject currently requiring mechanical ventilation
boolean
C0199470 (UMLS CUI [1,1])
C1514873 (UMLS CUI [1,2])
Lung Injury | Respiratory Distress Syndrome, Adult | Bilateral pulmonary infiltrates Chest X-ray | PaO2/FiO2 ratio | Left atrium Hypertension Absent
Item
subject with current diagnosis of acute lung injury or ards (bilateral infiltrates on chest x-ray and pf ratio< 300 with no evidence of left atrial hypertension)
boolean
C0273115 (UMLS CUI [1])
C0035222 (UMLS CUI [2])
C2939072 (UMLS CUI [3,1])
C0039985 (UMLS CUI [3,2])
C4087239 (UMLS CUI [4])
C0225860 (UMLS CUI [5,1])
C0020538 (UMLS CUI [5,2])
C0332197 (UMLS CUI [5,3])
Chemotherapy AML
Item
subject has received chemotherapy for the treatment of aml > 96 hours ago.
boolean
C0392920 (UMLS CUI [1,1])
C0023467 (UMLS CUI [1,2])
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