ID

39137

Beschrijving

Body Composition Monitor(BCM) Guided Fluid Management in Maintenance Hemodialysis (MHD) Patients; ODM derived from: https://clinicaltrials.gov/show/NCT01509937

Link

https://clinicaltrials.gov/show/NCT01509937

Trefwoorden

Versies (1)
  1. 05-12-19 05-12-19 -
Houder van rechten

See clinicaltrials.gov

Geüploaded op

5 december 2019

DOI

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Licentie

Creative Commons BY 4.0
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Eligibility End Stage Renal Disease NCT01509937

Engels

Eligibility End Stage Renal Disease NCT01509937

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
diagnosis of end stage renal disease (esrd) and need mhd
Beschrijving

Kidney Failure, Chronic | Patient need for Maintenance hemodialysis

Datatype

boolean

Alias
UMLS CUI [1]
C0022661
UMLS CUI [2,1]
C0686904
UMLS CUI [2,2]
C4040576
age of 18 years or older but 80 years or less
Beschrijving

Age

Datatype

boolean

Alias
UMLS CUI [1]
C0001779
on mhd for at least 3 months
Beschrijving

Maintenance hemodialysis Duration

Datatype

boolean

Alias
UMLS CUI [1,1]
C4040576
UMLS CUI [1,2]
C0449238
dialysis frequency of at least 5 sessions per 2 weeks, not less than 4 hours per session, kt/v at least 1.2
Beschrijving

Dialysis Frequency | Dialysis Duration | kt/V

Datatype

boolean

Alias
UMLS CUI [1,1]
C0011946
UMLS CUI [1,2]
C0439603
UMLS CUI [2,1]
C0011946
UMLS CUI [2,2]
C0449238
UMLS CUI [3]
C0429662
urine volume less than 800ml per 24 hours the day before dialysis session,
Beschrijving

Urine volume

Datatype

boolean

Alias
UMLS CUI [1]
C1278293
bioimpedance analysis not used within recent 3 months
Beschrijving

Bioimpedance Analysis Absent

Datatype

boolean

Alias
UMLS CUI [1,1]
C1704746
UMLS CUI [1,2]
C0332197
dry weight regarded as adequate according to the patient's responsible doctor
Beschrijving

Dry weight

Datatype

boolean

Alias
UMLS CUI [1]
C2709005
the ability to understand and willingness to sign an informed consent statement.
Beschrijving

Informed Consent

Datatype

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
acute infection within 1 month
Beschrijving

Communicable Disease

Datatype

boolean

Alias
UMLS CUI [1]
C0009450
active rheumatic disease, or current on cortical steroid medication or cytotoxic medication
Beschrijving

Rheumatic disorder | Adrenal Cortex Hormones | Cytotoxic agent

Datatype

boolean

Alias
UMLS CUI [1]
C3495832
UMLS CUI [2]
C0001617
UMLS CUI [3]
C0304497
uncontrolled neoplasm
Beschrijving

Neoplasm Uncontrolled

Datatype

boolean

Alias
UMLS CUI [1,1]
C0027651
UMLS CUI [1,2]
C0205318
acute myocardial infarction within 1 month
Beschrijving

Myocardial Infarction

Datatype

boolean

Alias
UMLS CUI [1]
C0027051
congestive heart failure (nyha 3 - 4)
Beschrijving

Congestive heart failure New York Heart Association Classification

Datatype

boolean

Alias
UMLS CUI [1,1]
C0018802
UMLS CUI [1,2]
C1275491
stroke within 3 months,
Beschrijving

Cerebrovascular accident

Datatype

boolean

Alias
UMLS CUI [1]
C0038454
metallic installation, like contraceptive device, artificial joint(s)
Beschrijving

Contraceptive Device | Artificial joint

Datatype

boolean

Alias
UMLS CUI [1]
C0009886
UMLS CUI [2]
C0481488
amputation
Beschrijving

Amputation

Datatype

boolean

Alias
UMLS CUI [1]
C0002688
female of childbearing age who has a pregnancy plan, or is pregnant, or on breast feeding
Beschrijving

Childbearing Potential Planned Pregnancy | Pregnancy | Breast Feeding

Datatype

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0032992
UMLS CUI [2]
C0032961
UMLS CUI [3]
C0006147
having a plan to reduce dialysis frequency
Beschrijving

Plan Reduction Dialysis Frequency

Datatype

boolean

Alias
UMLS CUI [1,1]
C1301732
UMLS CUI [1,2]
C0392756
UMLS CUI [1,3]
C0011946
UMLS CUI [1,4]
C0439603
having a renal transplantation plan or planning to transfer to peritoneal dialysis within 3 years
Beschrijving

Kidney Transplantation Planned | Transfer Peritoneal Dialysis Planned

Datatype

boolean

Alias
UMLS CUI [1,1]
C0022671
UMLS CUI [1,2]
C1301732
UMLS CUI [2,1]
C0030704
UMLS CUI [2,2]
C0031139
UMLS CUI [2,3]
C1301732
participating or planning to participate another clinical trial, which will confound the current study
Beschrijving

Study Subject Participation Status Interferes with Clinical Trial | Study Subject Participation Status | Clinical Trial Other Planned

Datatype

boolean

Alias
UMLS CUI [1,1]
C2348568
UMLS CUI [1,2]
C0521102
UMLS CUI [1,3]
C0008976
UMLS CUI [2]
C2348568
UMLS CUI [3,1]
C0008976
UMLS CUI [3,2]
C0205394
UMLS CUI [3,3]
C1301732
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Similar models

Eligibility End Stage Renal Disease NCT01509937

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Kidney Failure, Chronic | Patient need for Maintenance hemodialysis
Item
diagnosis of end stage renal disease (esrd) and need mhd
boolean
C0022661 (UMLS CUI [1])
C0686904 (UMLS CUI [2,1])
C4040576 (UMLS CUI [2,2])
Age
Item
age of 18 years or older but 80 years or less
boolean
C0001779 (UMLS CUI [1])
Maintenance hemodialysis Duration
Item
on mhd for at least 3 months
boolean
C4040576 (UMLS CUI [1,1])
C0449238 (UMLS CUI [1,2])
Dialysis Frequency | Dialysis Duration | kt/V
Item
dialysis frequency of at least 5 sessions per 2 weeks, not less than 4 hours per session, kt/v at least 1.2
boolean
C0011946 (UMLS CUI [1,1])
C0439603 (UMLS CUI [1,2])
C0011946 (UMLS CUI [2,1])
C0449238 (UMLS CUI [2,2])
C0429662 (UMLS CUI [3])
Urine volume
Item
urine volume less than 800ml per 24 hours the day before dialysis session,
boolean
C1278293 (UMLS CUI [1])
Bioimpedance Analysis Absent
Item
bioimpedance analysis not used within recent 3 months
boolean
C1704746 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
Dry weight
Item
dry weight regarded as adequate according to the patient's responsible doctor
boolean
C2709005 (UMLS CUI [1])
Informed Consent
Item
the ability to understand and willingness to sign an informed consent statement.
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Communicable Disease
Item
acute infection within 1 month
boolean
C0009450 (UMLS CUI [1])
Rheumatic disorder | Adrenal Cortex Hormones | Cytotoxic agent
Item
active rheumatic disease, or current on cortical steroid medication or cytotoxic medication
boolean
C3495832 (UMLS CUI [1])
C0001617 (UMLS CUI [2])
C0304497 (UMLS CUI [3])
Neoplasm Uncontrolled
Item
uncontrolled neoplasm
boolean
C0027651 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
Myocardial Infarction
Item
acute myocardial infarction within 1 month
boolean
C0027051 (UMLS CUI [1])
Congestive heart failure New York Heart Association Classification
Item
congestive heart failure (nyha 3 - 4)
boolean
C0018802 (UMLS CUI [1,1])
C1275491 (UMLS CUI [1,2])
Cerebrovascular accident
Item
stroke within 3 months,
boolean
C0038454 (UMLS CUI [1])
Contraceptive Device | Artificial joint
Item
metallic installation, like contraceptive device, artificial joint(s)
boolean
C0009886 (UMLS CUI [1])
C0481488 (UMLS CUI [2])
Amputation
Item
amputation
boolean
C0002688 (UMLS CUI [1])
Childbearing Potential Planned Pregnancy | Pregnancy | Breast Feeding
Item
female of childbearing age who has a pregnancy plan, or is pregnant, or on breast feeding
boolean
C3831118 (UMLS CUI [1,1])
C0032992 (UMLS CUI [1,2])
C0032961 (UMLS CUI [2])
C0006147 (UMLS CUI [3])
Plan Reduction Dialysis Frequency
Item
having a plan to reduce dialysis frequency
boolean
C1301732 (UMLS CUI [1,1])
C0392756 (UMLS CUI [1,2])
C0011946 (UMLS CUI [1,3])
C0439603 (UMLS CUI [1,4])
Kidney Transplantation Planned | Transfer Peritoneal Dialysis Planned
Item
having a renal transplantation plan or planning to transfer to peritoneal dialysis within 3 years
boolean
C0022671 (UMLS CUI [1,1])
C1301732 (UMLS CUI [1,2])
C0030704 (UMLS CUI [2,1])
C0031139 (UMLS CUI [2,2])
C1301732 (UMLS CUI [2,3])
Study Subject Participation Status Interferes with Clinical Trial | Study Subject Participation Status | Clinical Trial Other Planned
Item
participating or planning to participate another clinical trial, which will confound the current study
boolean
C2348568 (UMLS CUI [1,1])
C0521102 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])
C2348568 (UMLS CUI [2])
C0008976 (UMLS CUI [3,1])
C0205394 (UMLS CUI [3,2])
C1301732 (UMLS CUI [3,3])
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