ID

23908

Description

Concentrated Saline Infusions and Increased Dietary Sodium With Diuretics for Heart Failure With Kidney Dysfunction; ODM derived from: https://clinicaltrials.gov/show/NCT00575484

Lien

https://clinicaltrials.gov/show/NCT00575484

Mots-clés

Versions (1)
  1. 17/07/2017 17/07/2017 -
Téléchargé le

17 juillet 2017

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 Congestive Heart Failure NCT00575484

Anglais

Eligibility Congestive Heart Failure NCT00575484

1 Formulaires  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
adult patients (age ≥18) admitted with chf exacerbation with nyha class iii-iv symptoms at screening.
Description

Adult | Age | Exacerbation of congestive heart failure New York Heart Association Classification

Type de données

boolean

Alias
UMLS CUI [1]
C0001675
UMLS CUI [2]
C0001779
UMLS CUI [3,1]
C3532952
UMLS CUI [3,2]
C1275491
left ventricular ejection fraction </= 45%, as determined by previous echocardiogram, left ventricular angiogram, or thallium myocardial imaging.
Description

Left ventricular ejection fraction

Type de données

boolean

Alias
UMLS CUI [1]
C0428772
estimated gfr <60 ml/min/1.7m² with significant prerenal physiology as judged by prior documented volume mediated changes in renal function, a fractional excretion of urea <35%, or a fractional excretion of sodium <1%. for gfr 30-60: must have serum sodium </= 135 meq/l or large home diuretic dose (total daily loop diuretic dose >/= 120 mg/d in furosemide equivalents or concomitant thiazide use). for gfr <30: no additional criteria needed.
Description

Estimated Glomerular Filtration Rate | Physiology Prerenal | Renal alteration | Fractional excretion of urea | Measurement of fractional excretion of sodium | Serum sodium measurement | Furosemide Equivalent | Thiazides

Type de données

boolean

Alias
UMLS CUI [1]
C3811844
UMLS CUI [2,1]
C0031843
UMLS CUI [2,2]
C1550297
UMLS CUI [3]
C0184571
UMLS CUI [4]
C2923339
UMLS CUI [5]
C0428601
UMLS CUI [6]
C0523891
UMLS CUI [7,1]
C0016860
UMLS CUI [7,2]
C0205163
UMLS CUI [8]
C0541746
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
admit estimated gfr < 15ml/min or predicted need for chronic hemodialysis within the next 60 days.
Description

Estimated Glomerular Filtration Rate | Chronic haemodialysis Need predicted

Type de données

boolean

Alias
UMLS CUI [1]
C3811844
UMLS CUI [2,1]
C1740835
UMLS CUI [2,2]
C0027552
UMLS CUI [2,3]
C0681842
cause of acute kidney injury other than prerenal physiology.
Description

Injury of kidney Cause | Physiology Prerenal Excluded

Type de données

boolean

Alias
UMLS CUI [1,1]
C0160420
UMLS CUI [1,2]
C0015127
UMLS CUI [2,1]
C0031843
UMLS CUI [2,2]
C1550297
UMLS CUI [2,3]
C2828389
no loop diuretic prior to admission or loop diuretic initiated within the 2 wks prior to admission.
Description

Loop Diuretics

Type de données

boolean

Alias
UMLS CUI [1]
C0354100
medicine or dietary noncompliance expected to prevent successful study participation.
Description

Medication Nonadherence | Non-compliance Dietary

Type de données

boolean

Alias
UMLS CUI [1]
C0746935
UMLS CUI [2,1]
C0457432
UMLS CUI [2,2]
C0012155
> 36hrs since presentation to screening.
Description

Hour Quantity Since Screening

Type de données

boolean

Alias
UMLS CUI [1,1]
C0439227
UMLS CUI [1,2]
C1265611
UMLS CUI [1,3]
C1711239
UMLS CUI [1,4]
C0220908
serum na > 145 meq/l or < 120 meq/l at screening.
Description

Serum sodium measurement

Type de données

boolean

Alias
UMLS CUI [1]
C0523891
systolic blood pressure > 180 mmhg at screening.
Description

Systolic Pressure

Type de données

boolean

Alias
UMLS CUI [1]
C0871470
presentation with acute coronary syndrome or left heart catheterization planned at screening.
Description

Acute Coronary Syndrome | Catheterization of left heart Planned

Type de données

boolean

Alias
UMLS CUI [1]
C0948089
UMLS CUI [2,1]
C0189897
UMLS CUI [2,2]
C1301732
current or impending respiratory failure at screening.
Description

Respiratory Failure | RESPIRATORY FAILURE IMPENDING

Type de données

boolean

Alias
UMLS CUI [1]
C1145670
UMLS CUI [2]
C0748357
current calcineurin inhibitor or nesiritide use.
Description

Calcineurin inhibitor | Nesiritide

Type de données

boolean

Alias
UMLS CUI [1]
C1562036
UMLS CUI [2]
C0054015
nephrotic-range proteinuria.
Description

Nephrotic range proteinuria

Type de données

boolean

Alias
UMLS CUI [1]
C0445118
clinical evidence for the presence of cirrhosis with bilirubin >/= 2mg/dl or international normalized ratio (not on coumadin) >/= 1.7.
Description

Liver Cirrhosis | Serum total bilirubin measurement | International Normalized Ratio | Coumadin Excluded

Type de données

boolean

Alias
UMLS CUI [1]
C0023890
UMLS CUI [2]
C1278039
UMLS CUI [3]
C0525032
UMLS CUI [4,1]
C0699129
UMLS CUI [4,2]
C2828389
presence of another active medical issue which may prolong hospital admission or delay aggressive chf therapy.
Description

Medical Problem Prolonged hospitalization | Medical Problem Therapeutic procedure Aggressive Delayed | Congestive heart failure

Type de données

boolean

Alias
UMLS CUI [1,1]
C1254481
UMLS CUI [1,2]
C0745041
UMLS CUI [2,1]
C1254481
UMLS CUI [2,2]
C0087111
UMLS CUI [2,3]
C0580822
UMLS CUI [2,4]
C0205421
UMLS CUI [3]
C0018802
participation in another interventional study.
Description

Study Subject Participation Status | Interventional Study

Type de données

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2]
C3274035
pregnancy.
Description

Pregnancy

Type de données

boolean

Alias
UMLS CUI [1]
C0032961
prisoners.
Description

Prisoner

Type de données

boolean

Alias
UMLS CUI [1]
C0033167
Retour au début de la page

Similar models

Eligibility Congestive Heart Failure NCT00575484

1 Formulaires
Name
Type
Description | Question | Decode (Coded Value)
Type de données
Alias
Item Group
C1512693 (UMLS CUI)
Adult | Age | Exacerbation of congestive heart failure New York Heart Association Classification
Item
adult patients (age ≥18) admitted with chf exacerbation with nyha class iii-iv symptoms at screening.
boolean
C0001675 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
C3532952 (UMLS CUI [3,1])
C1275491 (UMLS CUI [3,2])
Left ventricular ejection fraction
Item
left ventricular ejection fraction </= 45%, as determined by previous echocardiogram, left ventricular angiogram, or thallium myocardial imaging.
boolean
C0428772 (UMLS CUI [1])
Estimated Glomerular Filtration Rate | Physiology Prerenal | Renal alteration | Fractional excretion of urea | Measurement of fractional excretion of sodium | Serum sodium measurement | Furosemide Equivalent | Thiazides
Item
estimated gfr <60 ml/min/1.7m² with significant prerenal physiology as judged by prior documented volume mediated changes in renal function, a fractional excretion of urea <35%, or a fractional excretion of sodium <1%. for gfr 30-60: must have serum sodium </= 135 meq/l or large home diuretic dose (total daily loop diuretic dose >/= 120 mg/d in furosemide equivalents or concomitant thiazide use). for gfr <30: no additional criteria needed.
boolean
C3811844 (UMLS CUI [1])
C0031843 (UMLS CUI [2,1])
C1550297 (UMLS CUI [2,2])
C0184571 (UMLS CUI [3])
C2923339 (UMLS CUI [4])
C0428601 (UMLS CUI [5])
C0523891 (UMLS CUI [6])
C0016860 (UMLS CUI [7,1])
C0205163 (UMLS CUI [7,2])
C0541746 (UMLS CUI [8])
Item Group
C0680251 (UMLS CUI)
Estimated Glomerular Filtration Rate | Chronic haemodialysis Need predicted
Item
admit estimated gfr < 15ml/min or predicted need for chronic hemodialysis within the next 60 days.
boolean
C3811844 (UMLS CUI [1])
C1740835 (UMLS CUI [2,1])
C0027552 (UMLS CUI [2,2])
C0681842 (UMLS CUI [2,3])
Injury of kidney Cause | Physiology Prerenal Excluded
Item
cause of acute kidney injury other than prerenal physiology.
boolean
C0160420 (UMLS CUI [1,1])
C0015127 (UMLS CUI [1,2])
C0031843 (UMLS CUI [2,1])
C1550297 (UMLS CUI [2,2])
C2828389 (UMLS CUI [2,3])
Loop Diuretics
Item
no loop diuretic prior to admission or loop diuretic initiated within the 2 wks prior to admission.
boolean
C0354100 (UMLS CUI [1])
Medication Nonadherence | Non-compliance Dietary
Item
medicine or dietary noncompliance expected to prevent successful study participation.
boolean
C0746935 (UMLS CUI [1])
C0457432 (UMLS CUI [2,1])
C0012155 (UMLS CUI [2,2])
Hour Quantity Since Screening
Item
> 36hrs since presentation to screening.
boolean
C0439227 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C1711239 (UMLS CUI [1,3])
C0220908 (UMLS CUI [1,4])
Serum sodium measurement
Item
serum na > 145 meq/l or < 120 meq/l at screening.
boolean
C0523891 (UMLS CUI [1])
Systolic Pressure
Item
systolic blood pressure > 180 mmhg at screening.
boolean
C0871470 (UMLS CUI [1])
Acute Coronary Syndrome | Catheterization of left heart Planned
Item
presentation with acute coronary syndrome or left heart catheterization planned at screening.
boolean
C0948089 (UMLS CUI [1])
C0189897 (UMLS CUI [2,1])
C1301732 (UMLS CUI [2,2])
Respiratory Failure | RESPIRATORY FAILURE IMPENDING
Item
current or impending respiratory failure at screening.
boolean
C1145670 (UMLS CUI [1])
C0748357 (UMLS CUI [2])
Calcineurin inhibitor | Nesiritide
Item
current calcineurin inhibitor or nesiritide use.
boolean
C1562036 (UMLS CUI [1])
C0054015 (UMLS CUI [2])
Nephrotic range proteinuria
Item
nephrotic-range proteinuria.
boolean
C0445118 (UMLS CUI [1])
Liver Cirrhosis | Serum total bilirubin measurement | International Normalized Ratio | Coumadin Excluded
Item
clinical evidence for the presence of cirrhosis with bilirubin >/= 2mg/dl or international normalized ratio (not on coumadin) >/= 1.7.
boolean
C0023890 (UMLS CUI [1])
C1278039 (UMLS CUI [2])
C0525032 (UMLS CUI [3])
C0699129 (UMLS CUI [4,1])
C2828389 (UMLS CUI [4,2])
Medical Problem Prolonged hospitalization | Medical Problem Therapeutic procedure Aggressive Delayed | Congestive heart failure
Item
presence of another active medical issue which may prolong hospital admission or delay aggressive chf therapy.
boolean
C1254481 (UMLS CUI [1,1])
C0745041 (UMLS CUI [1,2])
C1254481 (UMLS CUI [2,1])
C0087111 (UMLS CUI [2,2])
C0580822 (UMLS CUI [2,3])
C0205421 (UMLS CUI [2,4])
C0018802 (UMLS CUI [3])
Study Subject Participation Status | Interventional Study
Item
participation in another interventional study.
boolean
C2348568 (UMLS CUI [1])
C3274035 (UMLS CUI [2])
Pregnancy
Item
pregnancy.
boolean
C0032961 (UMLS CUI [1])
Prisoner
Item
prisoners.
boolean
C0033167 (UMLS CUI [1])
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