ID

23908

Beschrijving

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

Link

https://clinicaltrials.gov/show/NCT00575484

Trefwoorden

Versies (1)
  1. 17-07-17 17-07-17 -
Geüploaded op

17 juli 2017

DOI

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Licentie

Creative Commons BY 4.0
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Eligibility Congestive Heart Failure NCT00575484

Engels

Eligibility Congestive Heart Failure NCT00575484

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

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

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

Datatype

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.
Beschrijving

Left ventricular ejection fraction

Datatype

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.
Beschrijving

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

Datatype

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
Beschrijving

Exclusion Criteria

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

Estimated Glomerular Filtration Rate | Chronic haemodialysis Need predicted

Datatype

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.
Beschrijving

Injury of kidney Cause | Physiology Prerenal Excluded

Datatype

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.
Beschrijving

Loop Diuretics

Datatype

boolean

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

Medication Nonadherence | Non-compliance Dietary

Datatype

boolean

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

Hour Quantity Since Screening

Datatype

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.
Beschrijving

Serum sodium measurement

Datatype

boolean

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

Systolic Pressure

Datatype

boolean

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

Acute Coronary Syndrome | Catheterization of left heart Planned

Datatype

boolean

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

Respiratory Failure | RESPIRATORY FAILURE IMPENDING

Datatype

boolean

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

Calcineurin inhibitor | Nesiritide

Datatype

boolean

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

Nephrotic range proteinuria

Datatype

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.
Beschrijving

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

Datatype

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.
Beschrijving

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

Datatype

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.
Beschrijving

Study Subject Participation Status | Interventional Study

Datatype

boolean

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

Pregnancy

Datatype

boolean

Alias
UMLS CUI [1]
C0032961
prisoners.
Beschrijving

Prisoner

Datatype

boolean

Alias
UMLS CUI [1]
C0033167
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Similar models

Eligibility Congestive Heart Failure NCT00575484

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
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])
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