ID

39513

Description

Aquaresis Utility for Hyponatremic Acute Heart Failure Study; ODM derived from: https://clinicaltrials.gov/show/NCT02183792

Link

https://clinicaltrials.gov/show/NCT02183792

Keywords

Versions (1)
  1. 1/21/20 1/21/20 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

January 21, 2020

DOI

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License

Creative Commons BY 4.0
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Eligibility Heart Failure NCT02183792

English

Eligibility Heart Failure NCT02183792

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
acute hf with signs or symptoms of volume overload [i.e. elevated jugular venous pulsation (jvp), rales, edema]
Description

Heart failure | Sign or Symptom Fluid overload | Raised jugular venous pressure | Rales | Edema

Data type

boolean

Alias
UMLS CUI [1]
C0018801
UMLS CUI [2,1]
C3540840
UMLS CUI [2,2]
C0546817
UMLS CUI [3]
C0520861
UMLS CUI [4]
C0034642
UMLS CUI [5]
C0013604
serum sodium ≤ 130 meq/l at time of or within first 48 hours of hospitalization
Description

Serum sodium measurement

Data type

boolean

Alias
UMLS CUI [1]
C0523891
randomized within 48 hours of presentation to hospital
Description

Subject is Randomized

Data type

boolean

Alias
UMLS CUI [1]
C3815594
≥ 18 years of age
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
informed consent
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
severe symptomatic hyponatremia requiring acute treatment
Description

Hyponatremia Symptomatic Severe | Treatment required

Data type

boolean

Alias
UMLS CUI [1,1]
C0020625
UMLS CUI [1,2]
C0231220
UMLS CUI [1,3]
C0205082
UMLS CUI [2]
C0332121
severe renal impairment upon admission (creatinine clearance < 20 ml/min)
Description

Renal Insufficiency Severe | On admission | Creatinine clearance measurement

Data type

boolean

Alias
UMLS CUI [1,1]
C1565489
UMLS CUI [1,2]
C0205082
UMLS CUI [2]
C0457453
UMLS CUI [3]
C0373595
renal replacement therapy dependent, or requiring upon admission
Description

Renal Replacement Therapy Dependence | Requirement Admission

Data type

boolean

Alias
UMLS CUI [1,1]
C0206074
UMLS CUI [1,2]
C0439857
UMLS CUI [2,1]
C1514873
UMLS CUI [2,2]
C0809949
acute coronary syndrome on admission
Description

Acute Coronary Syndrome On admission

Data type

boolean

Alias
UMLS CUI [1,1]
C0948089
UMLS CUI [1,2]
C0457453
evidence of cardiogenic shock or requiring intravenous vasopressors
Description

Shock, Cardiogenic | Requirement Vasoconstrictor Agents Intravenous

Data type

boolean

Alias
UMLS CUI [1]
C0036980
UMLS CUI [2,1]
C1514873
UMLS CUI [2,2]
C0042397
UMLS CUI [2,3]
C1522726
pregnancy
Description

Pregnancy

Data type

boolean

Alias
UMLS CUI [1]
C0032961
patient requiring concomitant use of strong cyp3a4 inhibitors (clarithromycin, ketoconazole, itraconazole, ritonavir, indinavir, nelfinavir, saquinavir, nefazodone, and telithromycin)
Description

Requirement CYP3A4 Inhibitor Strong | Clarithromycin | Ketoconazole | Itraconazole | Ritonavir | Indinavir | Nelfinavir | Saquinavir | nefazodone | telithromycin

Data type

boolean

Alias
UMLS CUI [1,1]
C1514873
UMLS CUI [1,2]
C3830624
UMLS CUI [1,3]
C0442821
UMLS CUI [2]
C0055856
UMLS CUI [3]
C0022625
UMLS CUI [4]
C0064113
UMLS CUI [5]
C0292818
UMLS CUI [6]
C0376637
UMLS CUI [7]
C0525005
UMLS CUI [8]
C0286738
UMLS CUI [9]
C0068485
UMLS CUI [10]
C0907410
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Similar models

Eligibility Heart Failure NCT02183792

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Heart failure | Sign or Symptom Fluid overload | Raised jugular venous pressure | Rales | Edema
Item
acute hf with signs or symptoms of volume overload [i.e. elevated jugular venous pulsation (jvp), rales, edema]
boolean
C0018801 (UMLS CUI [1])
C3540840 (UMLS CUI [2,1])
C0546817 (UMLS CUI [2,2])
C0520861 (UMLS CUI [3])
C0034642 (UMLS CUI [4])
C0013604 (UMLS CUI [5])
Serum sodium measurement
Item
serum sodium ≤ 130 meq/l at time of or within first 48 hours of hospitalization
boolean
C0523891 (UMLS CUI [1])
Subject is Randomized
Item
randomized within 48 hours of presentation to hospital
boolean
C3815594 (UMLS CUI [1])
Age
Item
≥ 18 years of age
boolean
C0001779 (UMLS CUI [1])
Informed Consent
Item
informed consent
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Hyponatremia Symptomatic Severe | Treatment required
Item
severe symptomatic hyponatremia requiring acute treatment
boolean
C0020625 (UMLS CUI [1,1])
C0231220 (UMLS CUI [1,2])
C0205082 (UMLS CUI [1,3])
C0332121 (UMLS CUI [2])
Renal Insufficiency Severe | On admission | Creatinine clearance measurement
Item
severe renal impairment upon admission (creatinine clearance < 20 ml/min)
boolean
C1565489 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C0457453 (UMLS CUI [2])
C0373595 (UMLS CUI [3])
Renal Replacement Therapy Dependence | Requirement Admission
Item
renal replacement therapy dependent, or requiring upon admission
boolean
C0206074 (UMLS CUI [1,1])
C0439857 (UMLS CUI [1,2])
C1514873 (UMLS CUI [2,1])
C0809949 (UMLS CUI [2,2])
Acute Coronary Syndrome On admission
Item
acute coronary syndrome on admission
boolean
C0948089 (UMLS CUI [1,1])
C0457453 (UMLS CUI [1,2])
Shock, Cardiogenic | Requirement Vasoconstrictor Agents Intravenous
Item
evidence of cardiogenic shock or requiring intravenous vasopressors
boolean
C0036980 (UMLS CUI [1])
C1514873 (UMLS CUI [2,1])
C0042397 (UMLS CUI [2,2])
C1522726 (UMLS CUI [2,3])
Pregnancy
Item
pregnancy
boolean
C0032961 (UMLS CUI [1])
Requirement CYP3A4 Inhibitor Strong | Clarithromycin | Ketoconazole | Itraconazole | Ritonavir | Indinavir | Nelfinavir | Saquinavir | nefazodone | telithromycin
Item
patient requiring concomitant use of strong cyp3a4 inhibitors (clarithromycin, ketoconazole, itraconazole, ritonavir, indinavir, nelfinavir, saquinavir, nefazodone, and telithromycin)
boolean
C1514873 (UMLS CUI [1,1])
C3830624 (UMLS CUI [1,2])
C0442821 (UMLS CUI [1,3])
C0055856 (UMLS CUI [2])
C0022625 (UMLS CUI [3])
C0064113 (UMLS CUI [4])
C0292818 (UMLS CUI [5])
C0376637 (UMLS CUI [6])
C0525005 (UMLS CUI [7])
C0286738 (UMLS CUI [8])
C0068485 (UMLS CUI [9])
C0907410 (UMLS CUI [10])
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