ID

39135

Description

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

Link

https://clinicaltrials.gov/show/NCT01691053

Keywords

Versions (1)
  1. 12/4/19 12/4/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

December 4, 2019

DOI

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License

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

English

Eligibility End Stage Renal Disease / Hemodialysis NCT01691053

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
age >18 years
Description

Age

Data type

boolean

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

Hemodialysis

Data type

boolean

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

Dialysis procedure Quantity Weekly

Data type

boolean

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

Informed Consent

Data type

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

Data type

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

Data type

boolean

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

Life Expectancy

Data type

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

Data type

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

Data type

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

Data type

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

Data type

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

Data type

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

Data type

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

Data type

boolean

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

Absence Compliance Suspected | Compliance behavior Lacking

Data type

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 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
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])
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