ID

39135

Description

Mineralocorticoid Receptor Antagonists in End Stage Renal Disease; ODM derived from: https://clinicaltrials.gov/show/NCT01691053

Lien

https://clinicaltrials.gov/show/NCT01691053

Mots-clés

Versions (1)
  1. 04/12/2019 04/12/2019 -
Détendeur de droits

See clinicaltrials.gov

Téléchargé le

4 décembre 2019

DOI

Pour une demande vous connecter.

Licence

Creative Commons BY 4.0
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Eligibility End Stage Renal Disease / Hemodialysis NCT01691053

Anglais

Eligibility End Stage Renal Disease / Hemodialysis NCT01691053

1 Formulaires  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
age >18 years
Description

Age

Type de données

boolean

Alias
UMLS CUI [1]
C0001779
hemodialysis treatment for at least 3 months
Description

Hemodialysis

Type de données

boolean

Alias
UMLS CUI [1]
C0019004
at least 3 dialysis sessions per week
Description

Dialysis procedure Quantity Weekly

Type de données

boolean

Alias
UMLS CUI [1,1]
C0011946
UMLS CUI [1,2]
C1265611
UMLS CUI [1,3]
C0332174
written informed consent
Description

Informed Consent

Type de données

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
contraindications for cardiac magnet resonance imaging (cmr)
Description

Medical contraindication Magnetic Resonance Imaging cardiac

Type de données

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C0024485
UMLS CUI [1,3]
C0018787
mineralocorticoid receptor antagonist treatment within the last 6 months
Description

Mineralocorticoid Receptor Antagonist

Type de données

boolean

Alias
UMLS CUI [1]
C1579268
estimated life expectancy < 12 months as judged by the nephrologist
Description

Life Expectancy

Type de données

boolean

Alias
UMLS CUI [1]
C0023671
history of hyperkalemia, defined as pre-dialysis potassium > 6.5 mmol/l occurring ≥ 3 times within the last 3 months prior to enrolment.
Description

Hyperkalemia | Potassium measurement Pre-dialysis

Type de données

boolean

Alias
UMLS CUI [1]
C0020461
UMLS CUI [2,1]
C0202194
UMLS CUI [2,2]
C1264634
high risk to develop hyperkalemia defined as pre-dialysis potassium > 6.0 mmol/l
Description

High risk of Hyperkalemia | Potassium measurement Pre-dialysis

Type de données

boolean

Alias
UMLS CUI [1,1]
C0332167
UMLS CUI [1,2]
C0020461
UMLS CUI [2,1]
C0202194
UMLS CUI [2,2]
C1264634
hypotension (systolic blood pressure < 100 mmhg)
Description

Hypotension | Systolic Pressure

Type de données

boolean

Alias
UMLS CUI [1]
C0020649
UMLS CUI [2]
C0871470
planned kidney transplantation (living donor) within the prospected study duration
Description

Kidney Transplantation Planned | Living Donor

Type de données

boolean

Alias
UMLS CUI [1,1]
C0022671
UMLS CUI [1,2]
C1301732
UMLS CUI [2]
C0348050
any acute illness within the last 4 weeks precluding a study participation as judged by the nephrologist
Description

Illness Recent | Study Subject Participation Status Excluded

Type de données

boolean

Alias
UMLS CUI [1,1]
C0221423
UMLS CUI [1,2]
C0332185
UMLS CUI [2,1]
C2348568
UMLS CUI [2,2]
C0332196
non-amenorrheic women with child bearing potential without reliable contraception, pregnancy/lactation
Description

Gender Amenorrhea Absent | Childbearing Potential Contraceptive methods Absent | Pregnancy | Breast Feeding

Type de données

boolean

Alias
UMLS CUI [1,1]
C0079399
UMLS CUI [1,2]
C0002453
UMLS CUI [1,3]
C0332197
UMLS CUI [2,1]
C3831118
UMLS CUI [2,2]
C0700589
UMLS CUI [2,3]
C0332197
UMLS CUI [3]
C0032961
UMLS CUI [4]
C0006147
allergy/hypersensitivity to spironolactone
Description

Spironolactone allergy

Type de données

boolean

Alias
UMLS CUI [1]
C0571912
non-compliance suspected or demonstrated
Description

Absence Compliance Suspected | Compliance behavior Lacking

Type de données

boolean

Alias
UMLS CUI [1,1]
C0332197
UMLS CUI [1,2]
C1321605
UMLS CUI [1,3]
C0750491
UMLS CUI [2,1]
C1321605
UMLS CUI [2,2]
C0332268
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Similar models

Eligibility End Stage Renal Disease / Hemodialysis NCT01691053

1 Formulaires
Name
Type
Description | Question | Decode (Coded Value)
Type de données
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
age >18 years
boolean
C0001779 (UMLS CUI [1])
Hemodialysis
Item
hemodialysis treatment for at least 3 months
boolean
C0019004 (UMLS CUI [1])
Dialysis procedure Quantity Weekly
Item
at least 3 dialysis sessions per week
boolean
C0011946 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C0332174 (UMLS CUI [1,3])
Informed Consent
Item
written informed consent
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Medical contraindication Magnetic Resonance Imaging cardiac
Item
contraindications for cardiac magnet resonance imaging (cmr)
boolean
C1301624 (UMLS CUI [1,1])
C0024485 (UMLS CUI [1,2])
C0018787 (UMLS CUI [1,3])
Mineralocorticoid Receptor Antagonist
Item
mineralocorticoid receptor antagonist treatment within the last 6 months
boolean
C1579268 (UMLS CUI [1])
Life Expectancy
Item
estimated life expectancy < 12 months as judged by the nephrologist
boolean
C0023671 (UMLS CUI [1])
Hyperkalemia | Potassium measurement Pre-dialysis
Item
history of hyperkalemia, defined as pre-dialysis potassium > 6.5 mmol/l occurring ≥ 3 times within the last 3 months prior to enrolment.
boolean
C0020461 (UMLS CUI [1])
C0202194 (UMLS CUI [2,1])
C1264634 (UMLS CUI [2,2])
High risk of Hyperkalemia | Potassium measurement Pre-dialysis
Item
high risk to develop hyperkalemia defined as pre-dialysis potassium > 6.0 mmol/l
boolean
C0332167 (UMLS CUI [1,1])
C0020461 (UMLS CUI [1,2])
C0202194 (UMLS CUI [2,1])
C1264634 (UMLS CUI [2,2])
Hypotension | Systolic Pressure
Item
hypotension (systolic blood pressure < 100 mmhg)
boolean
C0020649 (UMLS CUI [1])
C0871470 (UMLS CUI [2])
Kidney Transplantation Planned | Living Donor
Item
planned kidney transplantation (living donor) within the prospected study duration
boolean
C0022671 (UMLS CUI [1,1])
C1301732 (UMLS CUI [1,2])
C0348050 (UMLS CUI [2])
Illness Recent | Study Subject Participation Status Excluded
Item
any acute illness within the last 4 weeks precluding a study participation as judged by the nephrologist
boolean
C0221423 (UMLS CUI [1,1])
C0332185 (UMLS CUI [1,2])
C2348568 (UMLS CUI [2,1])
C0332196 (UMLS CUI [2,2])
Gender Amenorrhea Absent | Childbearing Potential Contraceptive methods Absent | Pregnancy | Breast Feeding
Item
non-amenorrheic women with child bearing potential without reliable contraception, pregnancy/lactation
boolean
C0079399 (UMLS CUI [1,1])
C0002453 (UMLS CUI [1,2])
C0332197 (UMLS CUI [1,3])
C3831118 (UMLS CUI [2,1])
C0700589 (UMLS CUI [2,2])
C0332197 (UMLS CUI [2,3])
C0032961 (UMLS CUI [3])
C0006147 (UMLS CUI [4])
Spironolactone allergy
Item
allergy/hypersensitivity to spironolactone
boolean
C0571912 (UMLS CUI [1])
Absence Compliance Suspected | Compliance behavior Lacking
Item
non-compliance suspected or demonstrated
boolean
C0332197 (UMLS CUI [1,1])
C1321605 (UMLS CUI [1,2])
C0750491 (UMLS CUI [1,3])
C1321605 (UMLS CUI [2,1])
C0332268 (UMLS CUI [2,2])
Retour au début de la page 

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