ID

30111

Beskrivning

Lowering Salt Intake in Chronic Kidney Disease: A Pilot Randomized Crossover Trial; ODM derived from: https://clinicaltrials.gov/show/NCT00974636

Länk

https://clinicaltrials.gov/show/NCT00974636

Nyckelord

Versioner (1)
  1. 2018-05-11 2018-05-11 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

11 maj 2018

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Kidney Disease NCT00974636

Engelsk

Eligibility Kidney Disease NCT00974636

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
individuals eligible to participate in this study must meet all of the following criteria:
Beskrivning

Criteria Fulfill

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0243161
UMLS CUI [1,2]
C1550543
willing and able to provide written, signed informed consent after the nature of the study has been explained, and prior to any research-related procedures.
Beskrivning

Informed Consent

Datatyp

boolean

Alias
UMLS CUI [1]
C0021430
age ≥ 18 years and ≤ 85 years.
Beskrivning

Age

Datatyp

boolean

Alias
UMLS CUI [1]
C0001779
willing and able to comply with all study procedures.
Beskrivning

Protocol Compliance

Datatyp

boolean

Alias
UMLS CUI [1]
C0525058
patients with egfr of 20 to 60 ml/min/173m2 by the abbreviated (4-variable) mdrd equation and a relatively stable clinical course.
Beskrivning

Other Coding | Renal function GFR estimation by MDRD | Clinical course Stable

Datatyp

boolean

Alias
UMLS CUI [1]
C3846158
UMLS CUI [2]
C2170215
UMLS CUI [3,1]
C0449259
UMLS CUI [3,2]
C0205360
sitting systolic blood pressure ≥ 100 mmhg prior to study entry (to exclude people at risk from hypotension from dietary salt reduction).
Beskrivning

Sitting systolic blood pressure | Risk Hypotension | Etiology Dietary salt Reduction

Datatyp

boolean

Alias
UMLS CUI [1]
C1319893
UMLS CUI [2,1]
C0035647
UMLS CUI [2,2]
C0020649
UMLS CUI [3,1]
C0015127
UMLS CUI [3,2]
C0206136
UMLS CUI [3,3]
C0392756
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
individuals who meet any of the following exclusion criteria will not be eligible to participate in the study:
Beskrivning

Criteria Fulfill

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0243161
UMLS CUI [1,2]
C1550543
recent acute illness (≤1 month). minor ailments such as a recovered common cold or allergic rhinitis would not be considered as exclusion criteria but would be left to the site pi's discretion.
Beskrivning

Acute illness | Illness Minor | Common Cold Recovered | Allergic rhinitis

Datatyp

boolean

Alias
UMLS CUI [1]
C4061114
UMLS CUI [2,1]
C0221423
UMLS CUI [2,2]
C0205165
UMLS CUI [3,1]
C0009443
UMLS CUI [3,2]
C0521108
UMLS CUI [4]
C2607914
recent hospitalization (≤1 month) unless clearly for a minor elective procedure unlikely to interfere with bia measurements. the final decision will be left to the site pi's discretion.
Beskrivning

Hospitalization | Exception Elective procedure Minor | Interference Bioelectric Impedance Analysis Unlikely

Datatyp

boolean

Alias
UMLS CUI [1]
C0019993
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0747973
UMLS CUI [2,3]
C0205165
UMLS CUI [3,1]
C0521102
UMLS CUI [3,2]
C1704746
UMLS CUI [3,3]
C0750558
any psychological condition (including alcoholism) that could interfere with the patient's ability to comply with the study protocol.
Beskrivning

Mental condition Interferes with Protocol Compliance | Alcoholic Intoxication, Chronic

Datatyp

boolean

Alias
UMLS CUI [1,1]
C3840291
UMLS CUI [1,2]
C0521102
UMLS CUI [1,3]
C0525058
UMLS CUI [2]
C0001973
subjects with baseline 24-hour urinary sodium excretion ≤100 mmol/day.
Beskrivning

24 hour urine sodium output measurement

Datatyp

boolean

Alias
UMLS CUI [1]
C1278233
amputation of a limb other than fingers or toes.
Beskrivning

Amputation of limb | Exception Fingers | Exception Toes

Datatyp

boolean

Alias
UMLS CUI [1]
C0002689
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0016129
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0040357
pacemaker, defibrillator, implantable pump, artificial joint, pins, plates or other types of metal objects in the body (other than dental fillings).
Beskrivning

Artificial cardiac pacemaker | Defibrillators | Pumps, Implantable | Artificial joint | Pins | Plates | Metal device Body | Exception Tooth filling

Datatyp

boolean

Alias
UMLS CUI [1]
C0030163
UMLS CUI [2]
C0180307
UMLS CUI [3]
C0021438
UMLS CUI [4]
C0481488
UMLS CUI [5]
C0175718
UMLS CUI [6]
C1139930
UMLS CUI [7,1]
C0336536
UMLS CUI [7,2]
C1268086
UMLS CUI [8,1]
C1705847
UMLS CUI [8,2]
C0178866
coronary stents or metal suture material in the heart.
Beskrivning

Coronary artery stent | Suture Metallic Heart

Datatyp

boolean

Alias
UMLS CUI [1]
C0687568
UMLS CUI [2,1]
C0038969
UMLS CUI [2,2]
C2986473
UMLS CUI [2,3]
C0018787
use of any investigational product or investigational medical device within 30 days prior to screening, or requirement for any investigational agent prior to completion of all scheduled study assessments.
Beskrivning

Investigational New Drugs | Investigational Medical Device

Datatyp

boolean

Alias
UMLS CUI [1]
C0013230
UMLS CUI [2]
C2346570
weight over 300 pounds (limitation for examination table).
Beskrivning

Body Weight

Datatyp

boolean

Alias
UMLS CUI [1]
C0005910
pregnancy or lactation.
Beskrivning

Pregnancy | Breast Feeding

Datatyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
patients with kidney diseases known to be associated with salt wasting (see above).
Beskrivning

Kidney Diseases Associated with Salt wasting

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0022658
UMLS CUI [1,2]
C0332281
UMLS CUI [1,3]
C1846347
patients with atrial fibrillation as ambulatory blood pressure measurements may not be accurate in this setting.
Beskrivning

Atrial Fibrillation | At risk Blood pressure ambulatory Measurement

Datatyp

boolean

Alias
UMLS CUI [1]
C0004238
UMLS CUI [2,1]
C1444641
UMLS CUI [2,2]
C0855316
UMLS CUI [2,3]
C0242485
any condition that, in the view of the pi, places the subject at high risk of poor treatment compliance or of not completing the study.
Beskrivning

Condition At risk Compliance behavior Limited | Condition At risk Clinical Trial Incomplete

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0348080
UMLS CUI [1,2]
C1444641
UMLS CUI [1,3]
C1321605
UMLS CUI [1,4]
C0439801
UMLS CUI [2,1]
C0348080
UMLS CUI [2,2]
C1444641
UMLS CUI [2,3]
C0008976
UMLS CUI [2,4]
C0205257
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Similar models

Eligibility Kidney Disease NCT00974636

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Criteria Fulfill
Item
individuals eligible to participate in this study must meet all of the following criteria:
boolean
C0243161 (UMLS CUI [1,1])
C1550543 (UMLS CUI [1,2])
Informed Consent
Item
willing and able to provide written, signed informed consent after the nature of the study has been explained, and prior to any research-related procedures.
boolean
C0021430 (UMLS CUI [1])
Age
Item
age ≥ 18 years and ≤ 85 years.
boolean
C0001779 (UMLS CUI [1])
Protocol Compliance
Item
willing and able to comply with all study procedures.
boolean
C0525058 (UMLS CUI [1])
Other Coding | Renal function GFR estimation by MDRD | Clinical course Stable
Item
patients with egfr of 20 to 60 ml/min/173m2 by the abbreviated (4-variable) mdrd equation and a relatively stable clinical course.
boolean
C3846158 (UMLS CUI [1])
C2170215 (UMLS CUI [2])
C0449259 (UMLS CUI [3,1])
C0205360 (UMLS CUI [3,2])
Sitting systolic blood pressure | Risk Hypotension | Etiology Dietary salt Reduction
Item
sitting systolic blood pressure ≥ 100 mmhg prior to study entry (to exclude people at risk from hypotension from dietary salt reduction).
boolean
C1319893 (UMLS CUI [1])
C0035647 (UMLS CUI [2,1])
C0020649 (UMLS CUI [2,2])
C0015127 (UMLS CUI [3,1])
C0206136 (UMLS CUI [3,2])
C0392756 (UMLS CUI [3,3])
Item Group
C0680251 (UMLS CUI)
Criteria Fulfill
Item
individuals who meet any of the following exclusion criteria will not be eligible to participate in the study:
boolean
C0243161 (UMLS CUI [1,1])
C1550543 (UMLS CUI [1,2])
Acute illness | Illness Minor | Common Cold Recovered | Allergic rhinitis
Item
recent acute illness (≤1 month). minor ailments such as a recovered common cold or allergic rhinitis would not be considered as exclusion criteria but would be left to the site pi's discretion.
boolean
C4061114 (UMLS CUI [1])
C0221423 (UMLS CUI [2,1])
C0205165 (UMLS CUI [2,2])
C0009443 (UMLS CUI [3,1])
C0521108 (UMLS CUI [3,2])
C2607914 (UMLS CUI [4])
Hospitalization | Exception Elective procedure Minor | Interference Bioelectric Impedance Analysis Unlikely
Item
recent hospitalization (≤1 month) unless clearly for a minor elective procedure unlikely to interfere with bia measurements. the final decision will be left to the site pi's discretion.
boolean
C0019993 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0747973 (UMLS CUI [2,2])
C0205165 (UMLS CUI [2,3])
C0521102 (UMLS CUI [3,1])
C1704746 (UMLS CUI [3,2])
C0750558 (UMLS CUI [3,3])
Mental condition Interferes with Protocol Compliance | Alcoholic Intoxication, Chronic
Item
any psychological condition (including alcoholism) that could interfere with the patient's ability to comply with the study protocol.
boolean
C3840291 (UMLS CUI [1,1])
C0521102 (UMLS CUI [1,2])
C0525058 (UMLS CUI [1,3])
C0001973 (UMLS CUI [2])
24 hour urine sodium output measurement
Item
subjects with baseline 24-hour urinary sodium excretion ≤100 mmol/day.
boolean
C1278233 (UMLS CUI [1])
Amputation of limb | Exception Fingers | Exception Toes
Item
amputation of a limb other than fingers or toes.
boolean
C0002689 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0016129 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C0040357 (UMLS CUI [3,2])
Artificial cardiac pacemaker | Defibrillators | Pumps, Implantable | Artificial joint | Pins | Plates | Metal device Body | Exception Tooth filling
Item
pacemaker, defibrillator, implantable pump, artificial joint, pins, plates or other types of metal objects in the body (other than dental fillings).
boolean
C0030163 (UMLS CUI [1])
C0180307 (UMLS CUI [2])
C0021438 (UMLS CUI [3])
C0481488 (UMLS CUI [4])
C0175718 (UMLS CUI [5])
C1139930 (UMLS CUI [6])
C0336536 (UMLS CUI [7,1])
C1268086 (UMLS CUI [7,2])
C1705847 (UMLS CUI [8,1])
C0178866 (UMLS CUI [8,2])
Coronary artery stent | Suture Metallic Heart
Item
coronary stents or metal suture material in the heart.
boolean
C0687568 (UMLS CUI [1])
C0038969 (UMLS CUI [2,1])
C2986473 (UMLS CUI [2,2])
C0018787 (UMLS CUI [2,3])
Investigational New Drugs | Investigational Medical Device
Item
use of any investigational product or investigational medical device within 30 days prior to screening, or requirement for any investigational agent prior to completion of all scheduled study assessments.
boolean
C0013230 (UMLS CUI [1])
C2346570 (UMLS CUI [2])
Body Weight
Item
weight over 300 pounds (limitation for examination table).
boolean
C0005910 (UMLS CUI [1])
Pregnancy | Breast Feeding
Item
pregnancy or lactation.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Kidney Diseases Associated with Salt wasting
Item
patients with kidney diseases known to be associated with salt wasting (see above).
boolean
C0022658 (UMLS CUI [1,1])
C0332281 (UMLS CUI [1,2])
C1846347 (UMLS CUI [1,3])
Atrial Fibrillation | At risk Blood pressure ambulatory Measurement
Item
patients with atrial fibrillation as ambulatory blood pressure measurements may not be accurate in this setting.
boolean
C0004238 (UMLS CUI [1])
C1444641 (UMLS CUI [2,1])
C0855316 (UMLS CUI [2,2])
C0242485 (UMLS CUI [2,3])
Condition At risk Compliance behavior Limited | Condition At risk Clinical Trial Incomplete
Item
any condition that, in the view of the pi, places the subject at high risk of poor treatment compliance or of not completing the study.
boolean
C0348080 (UMLS CUI [1,1])
C1444641 (UMLS CUI [1,2])
C1321605 (UMLS CUI [1,3])
C0439801 (UMLS CUI [1,4])
C0348080 (UMLS CUI [2,1])
C1444641 (UMLS CUI [2,2])
C0008976 (UMLS CUI [2,3])
C0205257 (UMLS CUI [2,4])
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