ID

39496

Beskrivning

Acetazolamide and Spironolactone to Increase Natriuresis in Congestive Heart Failure; ODM derived from: https://clinicaltrials.gov/show/NCT01973335

Länk

https://clinicaltrials.gov/show/NCT01973335

Nyckelord

Versioner (1)
  1. 2020-01-19 2020-01-19 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

19 januari 2020

DOI

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Creative Commons BY 4.0
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Eligibility Heart Failure NCT01973335

Engelsk

Eligibility Heart Failure NCT01973335

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
older than 18 years and able to give informed consent
Beskrivning

Age | Informed Consent

Datatyp

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2]
C0021430
clinical diagnosis of acute decompensated heart failure within the previous 8 h
Beskrivning

Decompensated cardiac failure Recent

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0581377
UMLS CUI [1,2]
C0332185
at least two clinical signs of congestion (edema, ascites, jugular venous distension, or pulmonary vascular congestion on chest radiography)
Beskrivning

Sign or Symptom Quantity Congestion | Edema Chest X-ray | Ascites Chest X-ray | Jugular venous engorgement Chest X-ray | Pulmonary congestion Vascular Chest X-ray

Datatyp

boolean

Alias
UMLS CUI [1,1]
C3540840
UMLS CUI [1,2]
C1265611
UMLS CUI [1,3]
C0700148
UMLS CUI [2,1]
C0013604
UMLS CUI [2,2]
C0039985
UMLS CUI [3,1]
C0003962
UMLS CUI [3,2]
C0039985
UMLS CUI [4,1]
C0425687
UMLS CUI [4,2]
C0039985
UMLS CUI [5,1]
C0242073
UMLS CUI [5,2]
C1801960
UMLS CUI [5,3]
C0039985
maintenance therapy with oral loop diuretics at a dose of at least 1 mg bumetanide (1 mg bumetanide = 40 mg furosemide = 20 mg torsemide) for at least 1 month before hospital admission
Beskrivning

Maintenance therapy | Loop Diuretics Oral | Bumetanide Dose | Equivalent Furosemide Dose | Equivalent Torsemide Dose

Datatyp

boolean

Alias
UMLS CUI [1]
C0677908
UMLS CUI [2,1]
C0354100
UMLS CUI [2,2]
C1527415
UMLS CUI [3,1]
C0006376
UMLS CUI [3,2]
C0178602
UMLS CUI [4,1]
C0205163
UMLS CUI [4,2]
C0016860
UMLS CUI [4,3]
C0178602
UMLS CUI [5,1]
C0205163
UMLS CUI [5,2]
C0076840
UMLS CUI [5,3]
C0178602
nt-probnp >1000 ng/l
Beskrivning

N-Terminal ProB-type Natriuretic Peptide Measurement

Datatyp

boolean

Alias
UMLS CUI [1]
C3272900
left ventricular ejection fraction <50%
Beskrivning

Left ventricular ejection fraction

Datatyp

boolean

Alias
UMLS CUI [1]
C0428772
at least one out of three of the following criteria:
Beskrivning

Criteria Quantity

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0243161
UMLS CUI [1,2]
C1265611
serum sodium <136 mmol/l
Beskrivning

Serum sodium measurement

Datatyp

boolean

Alias
UMLS CUI [1]
C0523891
serum urea/creatinine ratio >50 (comparable to a bun/creatinine ratio >25)
Beskrivning

Urea to Creatinine Ratio Measurement | Comparison BUN/Creatinine ratio

Datatyp

boolean

Alias
UMLS CUI [1]
C3272926
UMLS CUI [2,1]
C1707455
UMLS CUI [2,2]
C0201922
admission serum creatinine increased with >0.3 mg/dl compared to previous value within 3 months before admission
Beskrivning

Serum creatinine raised

Datatyp

boolean

Alias
UMLS CUI [1]
C0700225
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
history of cardiac transplantation and/or ventricular assist device
Beskrivning

Heart Transplantation | Artificial Ventricle

Datatyp

boolean

Alias
UMLS CUI [1]
C0018823
UMLS CUI [2]
C0085842
concurrent diagnosis of an acute coronary syndrome defined as typical chest pain and/or electrocardiographic changes in addition to a troponin rise >99th percentile
Beskrivning

Acute Coronary Syndrome | Chest Pain Typical | Electrocardiographic changes In addition to Troponin increased

Datatyp

boolean

Alias
UMLS CUI [1]
C0948089
UMLS CUI [2,1]
C0008031
UMLS CUI [2,2]
C3538928
UMLS CUI [3,1]
C0855329
UMLS CUI [3,2]
C0332287
UMLS CUI [3,3]
C1141948
mean arterial blood pressure <65 mmhg, or systolic blood pressure <90 mmhg at the moment of admission
Beskrivning

Mean blood pressure | Systolic Pressure

Datatyp

boolean

Alias
UMLS CUI [1]
C0428886
UMLS CUI [2]
C0871470
use of intravenous inotropes, vasopressors or nitroprusside at any time point during the study
Beskrivning

Inotropic agent Intravenous | Vasoconstrictor Agents | Nitroprusside

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0304509
UMLS CUI [1,2]
C1522726
UMLS CUI [2]
C0042397
UMLS CUI [3]
C0028193
a baseline estimated glomerular filtration rate <15 ml/min/1.73m² according to the chronic kidney disease epidemiology collaboration (ckd-epi) formula at the moment of inclusion
Beskrivning

Estimated Glomerular Filtration Rate CKD-EPI

Datatyp

boolean

Alias
UMLS CUI [1,1]
C3811844
UMLS CUI [1,2]
C2964649
use of renal replacement therapy or ultrafiltration before study inclusion
Beskrivning

Renal Replacement Therapy | Ultrafiltration

Datatyp

boolean

Alias
UMLS CUI [1]
C0206074
UMLS CUI [2]
C0041612
treatment with acetazolamide within the previous month
Beskrivning

Acetazolamide

Datatyp

boolean

Alias
UMLS CUI [1]
C0000981
treatment with ≥2 mg bumetanide or an equivalent dose during the index hospitalization before randomization
Beskrivning

Bumetanide Dose | Equivalent Dose

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0006376
UMLS CUI [1,2]
C0178602
UMLS CUI [2,1]
C0205163
UMLS CUI [2,2]
C0178602
use of diuretics, vasopressin antagonists or mineralocorticoid receptor antagonist not specified by the protocol
Beskrivning

Diuretics | Vasopressin Antagonist | Mineralocorticoid Receptor Antagonists

Datatyp

boolean

Alias
UMLS CUI [1]
C0012798
UMLS CUI [2]
C3537128
UMLS CUI [3]
C1579268
exposure to nephrotoxic agents (i.e. contrast dye) anticipated within 3 days
Beskrivning

Exposure to Agent Nephrotoxic | Exposure to Contrast dye

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0332157
UMLS CUI [1,2]
C1254351
UMLS CUI [1,3]
C1514118
UMLS CUI [2,1]
C0332157
UMLS CUI [2,2]
C0742795
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Similar models

Eligibility Heart Failure NCT01973335

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Age | Informed Consent
Item
older than 18 years and able to give informed consent
boolean
C0001779 (UMLS CUI [1])
C0021430 (UMLS CUI [2])
Decompensated cardiac failure Recent
Item
clinical diagnosis of acute decompensated heart failure within the previous 8 h
boolean
C0581377 (UMLS CUI [1,1])
C0332185 (UMLS CUI [1,2])
Sign or Symptom Quantity Congestion | Edema Chest X-ray | Ascites Chest X-ray | Jugular venous engorgement Chest X-ray | Pulmonary congestion Vascular Chest X-ray
Item
at least two clinical signs of congestion (edema, ascites, jugular venous distension, or pulmonary vascular congestion on chest radiography)
boolean
C3540840 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C0700148 (UMLS CUI [1,3])
C0013604 (UMLS CUI [2,1])
C0039985 (UMLS CUI [2,2])
C0003962 (UMLS CUI [3,1])
C0039985 (UMLS CUI [3,2])
C0425687 (UMLS CUI [4,1])
C0039985 (UMLS CUI [4,2])
C0242073 (UMLS CUI [5,1])
C1801960 (UMLS CUI [5,2])
C0039985 (UMLS CUI [5,3])
Maintenance therapy | Loop Diuretics Oral | Bumetanide Dose | Equivalent Furosemide Dose | Equivalent Torsemide Dose
Item
maintenance therapy with oral loop diuretics at a dose of at least 1 mg bumetanide (1 mg bumetanide = 40 mg furosemide = 20 mg torsemide) for at least 1 month before hospital admission
boolean
C0677908 (UMLS CUI [1])
C0354100 (UMLS CUI [2,1])
C1527415 (UMLS CUI [2,2])
C0006376 (UMLS CUI [3,1])
C0178602 (UMLS CUI [3,2])
C0205163 (UMLS CUI [4,1])
C0016860 (UMLS CUI [4,2])
C0178602 (UMLS CUI [4,3])
C0205163 (UMLS CUI [5,1])
C0076840 (UMLS CUI [5,2])
C0178602 (UMLS CUI [5,3])
N-Terminal ProB-type Natriuretic Peptide Measurement
Item
nt-probnp >1000 ng/l
boolean
C3272900 (UMLS CUI [1])
Left ventricular ejection fraction
Item
left ventricular ejection fraction <50%
boolean
C0428772 (UMLS CUI [1])
Criteria Quantity
Item
at least one out of three of the following criteria:
boolean
C0243161 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
Serum sodium measurement
Item
serum sodium <136 mmol/l
boolean
C0523891 (UMLS CUI [1])
Urea to Creatinine Ratio Measurement | Comparison BUN/Creatinine ratio
Item
serum urea/creatinine ratio >50 (comparable to a bun/creatinine ratio >25)
boolean
C3272926 (UMLS CUI [1])
C1707455 (UMLS CUI [2,1])
C0201922 (UMLS CUI [2,2])
Serum creatinine raised
Item
admission serum creatinine increased with >0.3 mg/dl compared to previous value within 3 months before admission
boolean
C0700225 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Heart Transplantation | Artificial Ventricle
Item
history of cardiac transplantation and/or ventricular assist device
boolean
C0018823 (UMLS CUI [1])
C0085842 (UMLS CUI [2])
Acute Coronary Syndrome | Chest Pain Typical | Electrocardiographic changes In addition to Troponin increased
Item
concurrent diagnosis of an acute coronary syndrome defined as typical chest pain and/or electrocardiographic changes in addition to a troponin rise >99th percentile
boolean
C0948089 (UMLS CUI [1])
C0008031 (UMLS CUI [2,1])
C3538928 (UMLS CUI [2,2])
C0855329 (UMLS CUI [3,1])
C0332287 (UMLS CUI [3,2])
C1141948 (UMLS CUI [3,3])
Mean blood pressure | Systolic Pressure
Item
mean arterial blood pressure <65 mmhg, or systolic blood pressure <90 mmhg at the moment of admission
boolean
C0428886 (UMLS CUI [1])
C0871470 (UMLS CUI [2])
Inotropic agent Intravenous | Vasoconstrictor Agents | Nitroprusside
Item
use of intravenous inotropes, vasopressors or nitroprusside at any time point during the study
boolean
C0304509 (UMLS CUI [1,1])
C1522726 (UMLS CUI [1,2])
C0042397 (UMLS CUI [2])
C0028193 (UMLS CUI [3])
Estimated Glomerular Filtration Rate CKD-EPI
Item
a baseline estimated glomerular filtration rate <15 ml/min/1.73m² according to the chronic kidney disease epidemiology collaboration (ckd-epi) formula at the moment of inclusion
boolean
C3811844 (UMLS CUI [1,1])
C2964649 (UMLS CUI [1,2])
Renal Replacement Therapy | Ultrafiltration
Item
use of renal replacement therapy or ultrafiltration before study inclusion
boolean
C0206074 (UMLS CUI [1])
C0041612 (UMLS CUI [2])
Acetazolamide
Item
treatment with acetazolamide within the previous month
boolean
C0000981 (UMLS CUI [1])
Bumetanide Dose | Equivalent Dose
Item
treatment with ≥2 mg bumetanide or an equivalent dose during the index hospitalization before randomization
boolean
C0006376 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0205163 (UMLS CUI [2,1])
C0178602 (UMLS CUI [2,2])
Diuretics | Vasopressin Antagonist | Mineralocorticoid Receptor Antagonists
Item
use of diuretics, vasopressin antagonists or mineralocorticoid receptor antagonist not specified by the protocol
boolean
C0012798 (UMLS CUI [1])
C3537128 (UMLS CUI [2])
C1579268 (UMLS CUI [3])
Exposure to Agent Nephrotoxic | Exposure to Contrast dye
Item
exposure to nephrotoxic agents (i.e. contrast dye) anticipated within 3 days
boolean
C0332157 (UMLS CUI [1,1])
C1254351 (UMLS CUI [1,2])
C1514118 (UMLS CUI [1,3])
C0332157 (UMLS CUI [2,1])
C0742795 (UMLS CUI [2,2])
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