ID

13684

Description

Evaluation of RenalGuard® System to Reduce the Incidence of Contrast Induced Nephropathy in At-Risk Patients; ODM derived from: https://clinicaltrials.gov/show/NCT01456013

Lien

https://clinicaltrials.gov/show/NCT01456013

Mots-clés

Versions (1)
  1. 28/02/2016 28/02/2016 -
Téléchargé le

28 février 2016

DOI

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Licence

Creative Commons BY 4.0
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Eligibility Contrast Induced Nephropathy NCT01456013

Anglais

Eligibility Contrast Induced Nephropathy NCT01456013

1 Formulaires  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
male or non-pregnant female equal or greater than the age of 18 years old and is able to provide informed consent.
Description

age; gender; informed consent

Type de données

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2]
C0079399
UMLS CUI [3]
C0021430
subject is scheduled to undergo an elective catheterization procedure
Description

Catheterization elective

Type de données

boolean

Alias
UMLS CUI [1,1]
C0007430
UMLS CUI [1,2]
C0439608
hemodynamically stable
Description

hemodynamically stable

Type de données

boolean

Alias
UMLS CUI [1]
C0578150
at increased risk of developing cin
Description

Contrast Induced Nephropathy

Type de données

boolean

Alias
UMLS CUI [1]
C0748300
subject has agreed to all follow-up testing.
Description

testing follow-up

Type de données

boolean

Alias
UMLS CUI [1,1]
C0039593
UMLS CUI [1,2]
C1522577
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
class 3 or 4 congestive heart failure (chf)
Description

congestive heart failure

Type de données

boolean

Alias
UMLS CUI [1]
C0018802
is anuric or has undergone renal replacement therapy within the past month, or has a known inability to have a foley catheter placed.
Description

renal replacement therapy; foley catheter

Type de données

boolean

Alias
UMLS CUI [1]
C0206074
UMLS CUI [2]
C0179804
subject has been hospitalized or treated medically for any change in renal function over the past week (i.e. dialysis, etc.), or a significant change in renal function is noted at time of screening.
Description

hospitalization; dialysis; renal function

Type de données

boolean

Alias
UMLS CUI [1]
C0019993
UMLS CUI [2]
C0011946
UMLS CUI [3]
C0232804
has documented severe aortic stenosis.(note: subjects who have undergone successful replacement or repair of their aortic valve are not excluded.)
Description

severe aortic stenosis; Replacement of aortic valve

Type de données

boolean

Alias
UMLS CUI [1]
C3806272
UMLS CUI [2]
C0003506
currently has a known clinically significant electrolyte imbalance or clinically significant arrhythmias which compromise subject's hemodynamic state.
Description

Hemodynamics; electrolyte imbalance; Cardiac Arrhythmia

Type de données

boolean

Alias
UMLS CUI [1]
C0019010
UMLS CUI [2]
C0342579
UMLS CUI [3]
C0003811
patient has moderate to severe anemia (hematocrit < 27%) at screening
Description

severe anemia; Hematocrit level

Type de données

boolean

Alias
UMLS CUI [1]
C0238644
UMLS CUI [2]
C0518014
has received contrast within 10 days of procedure or has a planned additional cardiac or renal or other major surgical procedure within the7 day follow-up period.
Description

major surgical procedure

Type de données

boolean

Alias
UMLS CUI [1]
C0038894
has ruled in for an serious heart attack within 48 hours of the planned procedure
Description

heart attack

Type de données

boolean

Alias
UMLS CUI [1]
C0027051
has documented respiratory insufficiency as evidenced by an oxygen saturation of < 90% on room air assessed on day of procedure.
Description

respiratory insufficiency; Oxygen saturation measurement

Type de données

boolean

Alias
UMLS CUI [1]
C0035229
UMLS CUI [2]
C0523807
planned addition, discontinuation or dose adjustment of the nephrotoxic drugs
Description

dose adjustment; drug nephrotoxic

Type de données

boolean

Alias
UMLS CUI [1]
C2826232
UMLS CUI [2,1]
C0013227
UMLS CUI [2,2]
C1514118
subject has a known hypersensitivity to furosemide and/or the contrast agent being used.
Description

hypersensitivity furosemide

Type de données

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0016860
subject is currently, plans, or has been enrolled in another clinical study involving use of an investigational drug or device within the prior 30 days.
Description

Study Subject Participation Status

Type de données

boolean

Alias
UMLS CUI [1]
C2348568
subject is pregnant or breastfeeding.
Description

lactating; pregnant

Type de données

boolean

Alias
UMLS CUI [1]
C2828358
UMLS CUI [2]
C0549206
subject is unable to provide informed consent.
Description

informed consent

Type de données

boolean

Alias
UMLS CUI [1]
C0021430
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Similar models

Eligibility Contrast Induced Nephropathy NCT01456013

1 Formulaires
Name
Type
Description | Question | Decode (Coded Value)
Type de données
Alias
Item Group
C1512693 (UMLS CUI)
age; gender; informed consent
Item
male or non-pregnant female equal or greater than the age of 18 years old and is able to provide informed consent.
boolean
C0001779 (UMLS CUI [1])
C0079399 (UMLS CUI [2])
C0021430 (UMLS CUI [3])
Catheterization elective
Item
subject is scheduled to undergo an elective catheterization procedure
boolean
C0007430 (UMLS CUI [1,1])
C0439608 (UMLS CUI [1,2])
hemodynamically stable
Item
hemodynamically stable
boolean
C0578150 (UMLS CUI [1])
Contrast Induced Nephropathy
Item
at increased risk of developing cin
boolean
C0748300 (UMLS CUI [1])
testing follow-up
Item
subject has agreed to all follow-up testing.
boolean
C0039593 (UMLS CUI [1,1])
C1522577 (UMLS CUI [1,2])
Item Group
C0680251 (UMLS CUI)
congestive heart failure
Item
class 3 or 4 congestive heart failure (chf)
boolean
C0018802 (UMLS CUI [1])
renal replacement therapy; foley catheter
Item
is anuric or has undergone renal replacement therapy within the past month, or has a known inability to have a foley catheter placed.
boolean
C0206074 (UMLS CUI [1])
C0179804 (UMLS CUI [2])
hospitalization; dialysis; renal function
Item
subject has been hospitalized or treated medically for any change in renal function over the past week (i.e. dialysis, etc.), or a significant change in renal function is noted at time of screening.
boolean
C0019993 (UMLS CUI [1])
C0011946 (UMLS CUI [2])
C0232804 (UMLS CUI [3])
severe aortic stenosis; Replacement of aortic valve
Item
has documented severe aortic stenosis.(note: subjects who have undergone successful replacement or repair of their aortic valve are not excluded.)
boolean
C3806272 (UMLS CUI [1])
C0003506 (UMLS CUI [2])
Hemodynamics; electrolyte imbalance; Cardiac Arrhythmia
Item
currently has a known clinically significant electrolyte imbalance or clinically significant arrhythmias which compromise subject's hemodynamic state.
boolean
C0019010 (UMLS CUI [1])
C0342579 (UMLS CUI [2])
C0003811 (UMLS CUI [3])
severe anemia; Hematocrit level
Item
patient has moderate to severe anemia (hematocrit < 27%) at screening
boolean
C0238644 (UMLS CUI [1])
C0518014 (UMLS CUI [2])
major surgical procedure
Item
has received contrast within 10 days of procedure or has a planned additional cardiac or renal or other major surgical procedure within the7 day follow-up period.
boolean
C0038894 (UMLS CUI [1])
heart attack
Item
has ruled in for an serious heart attack within 48 hours of the planned procedure
boolean
C0027051 (UMLS CUI [1])
respiratory insufficiency; Oxygen saturation measurement
Item
has documented respiratory insufficiency as evidenced by an oxygen saturation of < 90% on room air assessed on day of procedure.
boolean
C0035229 (UMLS CUI [1])
C0523807 (UMLS CUI [2])
dose adjustment; drug nephrotoxic
Item
planned addition, discontinuation or dose adjustment of the nephrotoxic drugs
boolean
C2826232 (UMLS CUI [1])
C0013227 (UMLS CUI [2,1])
C1514118 (UMLS CUI [2,2])
hypersensitivity furosemide
Item
subject has a known hypersensitivity to furosemide and/or the contrast agent being used.
boolean
C0020517 (UMLS CUI [1,1])
C0016860 (UMLS CUI [1,2])
Study Subject Participation Status
Item
subject is currently, plans, or has been enrolled in another clinical study involving use of an investigational drug or device within the prior 30 days.
boolean
C2348568 (UMLS CUI [1])
lactating; pregnant
Item
subject is pregnant or breastfeeding.
boolean
C2828358 (UMLS CUI [1])
C0549206 (UMLS CUI [2])
informed consent
Item
subject is unable to provide informed consent.
boolean
C0021430 (UMLS CUI [1])
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