ID

39496

Description

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

Lien

https://clinicaltrials.gov/show/NCT01973335

Mots-clés

Versions (1)
  1. 19/01/2020 19/01/2020 -
Détendeur de droits

See clinicaltrials.gov

Téléchargé le

19 janvier 2020

DOI

Pour une demande vous connecter.

Licence

Creative Commons BY 4.0
Modèle Commentaires :

Ici, vous pouvez faire des commentaires sur le modèle. À partir des bulles de texte, vous pouvez laisser des commentaires spécifiques sur les groupes Item et les Item.

Retour au modèle Commentaires
Groupe Item commentaires pour :

Item commentaires pour :

Vous devez être connecté pour pouvoir télécharger des formulaires. Veuillez vous connecter ou s’inscrire gratuitement.

Eligibility Heart Failure NCT01973335

Anglais

Eligibility Heart Failure NCT01973335

1 Formulaires  
Inclusion Criteria
Description

Inclusion Criteria

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

Age | Informed Consent

Type de données

boolean

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

Decompensated cardiac failure Recent

Type de données

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)
Description

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

Type de données

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
Description

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

Type de données

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
Description

N-Terminal ProB-type Natriuretic Peptide Measurement

Type de données

boolean

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

Left ventricular ejection fraction

Type de données

boolean

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

Criteria Quantity

Type de données

boolean

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

Serum sodium measurement

Type de données

boolean

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

Urea to Creatinine Ratio Measurement | Comparison BUN/Creatinine ratio

Type de données

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
Description

Serum creatinine raised

Type de données

boolean

Alias
UMLS CUI [1]
C0700225
Exclusion Criteria
Description

Exclusion Criteria

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

Heart Transplantation | Artificial Ventricle

Type de données

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
Description

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

Type de données

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
Description

Mean blood pressure | Systolic Pressure

Type de données

boolean

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

Inotropic agent Intravenous | Vasoconstrictor Agents | Nitroprusside

Type de données

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
Description

Estimated Glomerular Filtration Rate CKD-EPI

Type de données

boolean

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

Renal Replacement Therapy | Ultrafiltration

Type de données

boolean

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

Acetazolamide

Type de données

boolean

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

Bumetanide Dose | Equivalent Dose

Type de données

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
Description

Diuretics | Vasopressin Antagonist | Mineralocorticoid Receptor Antagonists

Type de données

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
Description

Exposure to Agent Nephrotoxic | Exposure to Contrast dye

Type de données

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
Retour au début de la page

Similar models

Eligibility Heart Failure NCT01973335

1 Formulaires
Name
Type
Description | Question | Decode (Coded Value)
Type de données
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])
Retour au début de la page 

Contact

Utilisez ce formulaire pour les retours, les questions et les améliorations suggérées.

Les champs marqués d’un * sont obligatoires.

Aide

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial