ID

39156

Description

L-Arginine and Spironolactone Trial in Dialysis-Dependent ESRD; ODM derived from: https://clinicaltrials.gov/show/NCT01855334

Link

https://clinicaltrials.gov/show/NCT01855334

Keywords

Versions (1)
  1. 12/5/19 12/5/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

December 5, 2019

DOI

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License

Creative Commons BY 4.0
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Eligibility End Stage Renal Disease NCT01855334

English

Eligibility End Stage Renal Disease NCT01855334

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
chronic dialysis therapy for end stage renal disease
Description

Chronic dialysis End stage renal disease

Data type

boolean

Alias
UMLS CUI [1,1]
C0743165
UMLS CUI [1,2]
C0022661
age 21-85
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
hyperkalemia requiring unscheduled dialysis within 3 months
Description

Hyperkalemia | Requirement Dialysis Unscheduled

Data type

boolean

Alias
UMLS CUI [1]
C0020461
UMLS CUI [2,1]
C1514873
UMLS CUI [2,2]
C0011946
UMLS CUI [2,3]
C3854240
pre-dialysis potassium ≥6.5 meq/l within 3 months
Description

Potassium measurement Pre-dialysis

Data type

boolean

Alias
UMLS CUI [1,1]
C0202194
UMLS CUI [1,2]
C1264634
hypotension defined as sbp <100
Description

Hypotension | Systolic Pressure

Data type

boolean

Alias
UMLS CUI [1]
C0020649
UMLS CUI [2]
C0871470
recurrent intra-dialytic hypotension defined as recurrent cramping, light-headedness, or hypotension requiring infusion of saline or other intervention or otherwise limiting ability to achieve dry weight. or sbp <80
Description

Hypotension of hemodialysis Recurrent | Cramping Recurrent | Lightheadedness | Hypotension Requirement Infusion of saline solution; | Hypotension Requirement Intervention | Systolic Pressure

Data type

boolean

Alias
UMLS CUI [1,1]
C1260413
UMLS CUI [1,2]
C2945760
UMLS CUI [2,1]
C0026821
UMLS CUI [2,2]
C2945760
UMLS CUI [3]
C0220870
UMLS CUI [4,1]
C0020649
UMLS CUI [4,2]
C1514873
UMLS CUI [4,3]
C0199797
UMLS CUI [5,1]
C0020649
UMLS CUI [5,2]
C1514873
UMLS CUI [5,3]
C0184661
UMLS CUI [6]
C0871470
history of myocardial infarction
Description

Myocardial Infarction

Data type

boolean

Alias
UMLS CUI [1]
C0027051
history of coronary artery bypass surgery
Description

Coronary Artery Bypass Surgery

Data type

boolean

Alias
UMLS CUI [1]
C0010055
non revascularized coronary disease >90%
Description

Coronary heart disease Percentage | Coronary revascularisation Absent

Data type

boolean

Alias
UMLS CUI [1,1]
C0010068
UMLS CUI [1,2]
C0439165
UMLS CUI [2,1]
C0877341
UMLS CUI [2,2]
C0332197
mitral valve repair or replacement
Description

Mitral valvuloplasty | Replacement of mitral valve

Data type

boolean

Alias
UMLS CUI [1]
C0396849
UMLS CUI [2]
C0026268
severe mitral valve disease
Description

Disease of mitral valve Severe

Data type

boolean

Alias
UMLS CUI [1,1]
C0026265
UMLS CUI [1,2]
C0205082
renal transplant expected within 9 months
Description

Kidney Transplantation Expected

Data type

boolean

Alias
UMLS CUI [1,1]
C0022671
UMLS CUI [1,2]
C1517001
expected survival < 9 months
Description

Life Expectancy

Data type

boolean

Alias
UMLS CUI [1]
C0023671
pregnant
Description

Pregnancy

Data type

boolean

Alias
UMLS CUI [1]
C0032961
prisoners
Description

Prisoners

Data type

boolean

Alias
UMLS CUI [1]
C0033167
unable to provide consent
Description

Informed Consent Unable

Data type

boolean

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C1299582
allergy to spironolactone or l-arginine
Description

Spironolactone allergy | Hypersensitivity Arginine

Data type

boolean

Alias
UMLS CUI [1]
C0571912
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C0003765
digitalis use
Description

Use of Digitalis preparation

Data type

boolean

Alias
UMLS CUI [1,1]
C1524063
UMLS CUI [1,2]
C0304520
1st or 2nd degree heart block
Description

First degree atrioventricular block | Second degree atrioventricular block

Data type

boolean

Alias
UMLS CUI [1]
C0085614
UMLS CUI [2]
C0264906
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Similar models

Eligibility End Stage Renal Disease NCT01855334

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Chronic dialysis End stage renal disease
Item
chronic dialysis therapy for end stage renal disease
boolean
C0743165 (UMLS CUI [1,1])
C0022661 (UMLS CUI [1,2])
Age
Item
age 21-85
boolean
C0001779 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Hyperkalemia | Requirement Dialysis Unscheduled
Item
hyperkalemia requiring unscheduled dialysis within 3 months
boolean
C0020461 (UMLS CUI [1])
C1514873 (UMLS CUI [2,1])
C0011946 (UMLS CUI [2,2])
C3854240 (UMLS CUI [2,3])
Potassium measurement Pre-dialysis
Item
pre-dialysis potassium ≥6.5 meq/l within 3 months
boolean
C0202194 (UMLS CUI [1,1])
C1264634 (UMLS CUI [1,2])
Hypotension | Systolic Pressure
Item
hypotension defined as sbp <100
boolean
C0020649 (UMLS CUI [1])
C0871470 (UMLS CUI [2])
Hypotension of hemodialysis Recurrent | Cramping Recurrent | Lightheadedness | Hypotension Requirement Infusion of saline solution; | Hypotension Requirement Intervention | Systolic Pressure
Item
recurrent intra-dialytic hypotension defined as recurrent cramping, light-headedness, or hypotension requiring infusion of saline or other intervention or otherwise limiting ability to achieve dry weight. or sbp <80
boolean
C1260413 (UMLS CUI [1,1])
C2945760 (UMLS CUI [1,2])
C0026821 (UMLS CUI [2,1])
C2945760 (UMLS CUI [2,2])
C0220870 (UMLS CUI [3])
C0020649 (UMLS CUI [4,1])
C1514873 (UMLS CUI [4,2])
C0199797 (UMLS CUI [4,3])
C0020649 (UMLS CUI [5,1])
C1514873 (UMLS CUI [5,2])
C0184661 (UMLS CUI [5,3])
C0871470 (UMLS CUI [6])
Myocardial Infarction
Item
history of myocardial infarction
boolean
C0027051 (UMLS CUI [1])
Coronary Artery Bypass Surgery
Item
history of coronary artery bypass surgery
boolean
C0010055 (UMLS CUI [1])
Coronary heart disease Percentage | Coronary revascularisation Absent
Item
non revascularized coronary disease >90%
boolean
C0010068 (UMLS CUI [1,1])
C0439165 (UMLS CUI [1,2])
C0877341 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
Mitral valvuloplasty | Replacement of mitral valve
Item
mitral valve repair or replacement
boolean
C0396849 (UMLS CUI [1])
C0026268 (UMLS CUI [2])
Disease of mitral valve Severe
Item
severe mitral valve disease
boolean
C0026265 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
Kidney Transplantation Expected
Item
renal transplant expected within 9 months
boolean
C0022671 (UMLS CUI [1,1])
C1517001 (UMLS CUI [1,2])
Life Expectancy
Item
expected survival < 9 months
boolean
C0023671 (UMLS CUI [1])
Pregnancy
Item
pregnant
boolean
C0032961 (UMLS CUI [1])
Prisoners
Item
prisoners
boolean
C0033167 (UMLS CUI [1])
Informed Consent Unable
Item
unable to provide consent
boolean
C0021430 (UMLS CUI [1,1])
C1299582 (UMLS CUI [1,2])
Spironolactone allergy | Hypersensitivity Arginine
Item
allergy to spironolactone or l-arginine
boolean
C0571912 (UMLS CUI [1])
C0020517 (UMLS CUI [2,1])
C0003765 (UMLS CUI [2,2])
Use of Digitalis preparation
Item
digitalis use
boolean
C1524063 (UMLS CUI [1,1])
C0304520 (UMLS CUI [1,2])
First degree atrioventricular block | Second degree atrioventricular block
Item
1st or 2nd degree heart block
boolean
C0085614 (UMLS CUI [1])
C0264906 (UMLS CUI [2])
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