ID

20506

Beschrijving

COmbined N-acetylcysteine and Bicarbonate in PCI To Reduce Adverse Side Effect of contrasT; ODM derived from: https://clinicaltrials.gov/show/NCT00497328

Link

https://clinicaltrials.gov/show/NCT00497328

Trefwoorden

Versies (1)
  1. 28-02-17 28-02-17 -
Geüploaded op

28 februari 2017

DOI

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Licentie

Creative Commons BY 4.0
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Eligibility Contrast Induced Nephropathy NCT00497328

Engels

Eligibility Contrast Induced Nephropathy NCT00497328

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
age > 21 year
Beschrijving

age

Datatype

boolean

Alias
UMLS CUI [1]
C0001779
glomerular filtration rate (gfr) 15-60ml/min calculated by mdrd formula
Beschrijving

gfr

Datatype

boolean

Alias
UMLS CUI [1]
C0017654
scheduled to undergo elective pci
Beschrijving

scheduled to undergo elective pci

Datatype

boolean

Alias
UMLS CUI [1,1]
C0439608
UMLS CUI [1,2]
C1532338
able to receive 12 hours of pre-hydration
Beschrijving

able to receive 12 hours of pre-hydration

Datatype

boolean

Alias
UMLS CUI [1]
C2034482
written informed consent
Beschrijving

informed consent

Datatype

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
gfr less than 15ml/min or patients diagnosed with end stage renal failure
Beschrijving

gfr, end stage renal failure

Datatype

boolean

Alias
UMLS CUI [1,1]
C0017654
UMLS CUI [1,2]
C0022661
increase in serum creatinine levels of > 0.5mg/dl or 44umol/l in the previous 24 hours
Beschrijving

creatinine

Datatype

boolean

Alias
UMLS CUI [1]
C0201976
preexisting dialysis
Beschrijving

dialysis

Datatype

boolean

Alias
UMLS CUI [1]
C0011946
pulmonary edema or moderate to severe congestive heart failure (new york heart association [nyha] iii-iv)
Beschrijving

pulmonary edema, congestive heart failure

Datatype

boolean

Alias
UMLS CUI [1]
C0034063
UMLS CUI [2,1]
C0018802
UMLS CUI [2,2]
C1275491
patient unable to withstand the fluid load and hemodynamics compromise
Beschrijving

Fluid Therapy; Hemodynamic regulation

Datatype

boolean

Alias
UMLS CUI [1,1]
C0016286
UMLS CUI [1,2]
C0150249
uncontrolled hypertension (untreated systolic blood pressure > 160 mmhg, or diastolic blood pressure > 100mmhg.)
Beschrijving

uncontrolled hypertension

Datatype

boolean

Alias
UMLS CUI [1]
C1868885
emergency cardiac catheterization (i.e. patient presenting with st segment elevation myocardial infarction undergoing primary angioplasty)
Beschrijving

emergency cardiac catheterization

Datatype

boolean

Alias
UMLS CUI [1]
C1532297
recent exposure to radiographic contrast (within two days of the study).
Beschrijving

recent exposure to radiographic contrast

Datatype

boolean

Alias
UMLS CUI [1,1]
C2220266
UMLS CUI [1,2]
C0009924
allergic to radio-contrast
Beschrijving

allergic to radio-contrast

Datatype

boolean

Alias
UMLS CUI [1]
C0570562
administration of sodium bicarbonate solution or nac within 48 hours before the pci.
Beschrijving

sodium bicarbonate solution or nac before pci

Datatype

boolean

Alias
UMLS CUI [1,1]
C1247967
UMLS CUI [1,2]
C2034490
UMLS CUI [2]
C1532338
patient unable to give consent
Beschrijving

informed consent

Datatype

boolean

Alias
UMLS CUI [1]
C0021430
clinically vulnerable condition requiring continuous fluid therapy e.g. severe sepsis
Beschrijving

Acute Disease | Continuous; Fluid Therapy

Datatype

boolean

Alias
UMLS CUI [1]
C0001314
UMLS CUI [2,1]
C0549178
UMLS CUI [2,2]
C0016286
use of nsaid, aminoglycocide, cyclosporin, cysplatin within 48 hours prior to pci and throughout the study duration
Beschrijving

Use of; Anti-Inflammatory Agents, Non-Steroidal; Aminoglycosides; Cyclosporine; Cisplatin | Percutaneous Coronary Intervention

Datatype

boolean

Alias
UMLS CUI [1,1]
C1524063
UMLS CUI [1,2]
C0003211
UMLS CUI [1,3]
C0002556
UMLS CUI [1,4]
C0010592
UMLS CUI [1,5]
C0008838
UMLS CUI [2]
C1532338
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Similar models

Eligibility Contrast Induced Nephropathy NCT00497328

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
age
Item
age > 21 year
boolean
C0001779 (UMLS CUI [1])
gfr
Item
glomerular filtration rate (gfr) 15-60ml/min calculated by mdrd formula
boolean
C0017654 (UMLS CUI [1])
scheduled to undergo elective pci
Item
scheduled to undergo elective pci
boolean
C0439608 (UMLS CUI [1,1])
C1532338 (UMLS CUI [1,2])
able to receive 12 hours of pre-hydration
Item
able to receive 12 hours of pre-hydration
boolean
C2034482 (UMLS CUI [1])
informed consent
Item
written informed consent
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
gfr, end stage renal failure
Item
gfr less than 15ml/min or patients diagnosed with end stage renal failure
boolean
C0017654 (UMLS CUI [1,1])
C0022661 (UMLS CUI [1,2])
creatinine
Item
increase in serum creatinine levels of > 0.5mg/dl or 44umol/l in the previous 24 hours
boolean
C0201976 (UMLS CUI [1])
dialysis
Item
preexisting dialysis
boolean
C0011946 (UMLS CUI [1])
pulmonary edema, congestive heart failure
Item
pulmonary edema or moderate to severe congestive heart failure (new york heart association [nyha] iii-iv)
boolean
C0034063 (UMLS CUI [1])
C0018802 (UMLS CUI [2,1])
C1275491 (UMLS CUI [2,2])
Fluid Therapy; Hemodynamic regulation
Item
patient unable to withstand the fluid load and hemodynamics compromise
boolean
C0016286 (UMLS CUI [1,1])
C0150249 (UMLS CUI [1,2])
uncontrolled hypertension
Item
uncontrolled hypertension (untreated systolic blood pressure > 160 mmhg, or diastolic blood pressure > 100mmhg.)
boolean
C1868885 (UMLS CUI [1])
emergency cardiac catheterization
Item
emergency cardiac catheterization (i.e. patient presenting with st segment elevation myocardial infarction undergoing primary angioplasty)
boolean
C1532297 (UMLS CUI [1])
recent exposure to radiographic contrast
Item
recent exposure to radiographic contrast (within two days of the study).
boolean
C2220266 (UMLS CUI [1,1])
C0009924 (UMLS CUI [1,2])
allergic to radio-contrast
Item
allergic to radio-contrast
boolean
C0570562 (UMLS CUI [1])
sodium bicarbonate solution or nac before pci
Item
administration of sodium bicarbonate solution or nac within 48 hours before the pci.
boolean
C1247967 (UMLS CUI [1,1])
C2034490 (UMLS CUI [1,2])
C1532338 (UMLS CUI [2])
informed consent
Item
patient unable to give consent
boolean
C0021430 (UMLS CUI [1])
Acute Disease | Continuous; Fluid Therapy
Item
clinically vulnerable condition requiring continuous fluid therapy e.g. severe sepsis
boolean
C0001314 (UMLS CUI [1])
C0549178 (UMLS CUI [2,1])
C0016286 (UMLS CUI [2,2])
Use of; Anti-Inflammatory Agents, Non-Steroidal; Aminoglycosides; Cyclosporine; Cisplatin | Percutaneous Coronary Intervention
Item
use of nsaid, aminoglycocide, cyclosporin, cysplatin within 48 hours prior to pci and throughout the study duration
boolean
C1524063 (UMLS CUI [1,1])
C0003211 (UMLS CUI [1,2])
C0002556 (UMLS CUI [1,3])
C0010592 (UMLS CUI [1,4])
C0008838 (UMLS CUI [1,5])
C1532338 (UMLS CUI [2])
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