ID

39137

Descrição

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

Palavras-chave

  1. 05/12/2019 05/12/2019 -
Titular dos direitos

See clinicaltrials.gov

Transferido a

5 de dezembro de 2019

DOI

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Licença

Creative Commons BY 4.0

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Eligibility End Stage Renal Disease NCT01509937

Eligibility End Stage Renal Disease NCT01509937

Inclusion Criteria
Descrição

Inclusion Criteria

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

Kidney Failure, Chronic | Patient need for Maintenance hemodialysis

Tipo de dados

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
Descrição

Age

Tipo de dados

boolean

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

Maintenance hemodialysis Duration

Tipo de dados

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
Descrição

Dialysis Frequency | Dialysis Duration | kt/V

Tipo de dados

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,
Descrição

Urine volume

Tipo de dados

boolean

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

Bioimpedance Analysis Absent

Tipo de dados

boolean

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

Dry weight

Tipo de dados

boolean

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

Informed Consent

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Descrição

Exclusion Criteria

Alias
UMLS CUI
C0680251
acute infection within 1 month
Descrição

Communicable Disease

Tipo de dados

boolean

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

Rheumatic disorder | Adrenal Cortex Hormones | Cytotoxic agent

Tipo de dados

boolean

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

Neoplasm Uncontrolled

Tipo de dados

boolean

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

Myocardial Infarction

Tipo de dados

boolean

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

Congestive heart failure New York Heart Association Classification

Tipo de dados

boolean

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

Cerebrovascular accident

Tipo de dados

boolean

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

Contraceptive Device | Artificial joint

Tipo de dados

boolean

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

Amputation

Tipo de dados

boolean

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

Childbearing Potential Planned Pregnancy | Pregnancy | Breast Feeding

Tipo de dados

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
Descrição

Plan Reduction Dialysis Frequency

Tipo de dados

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
Descrição

Kidney Transplantation Planned | Transfer Peritoneal Dialysis Planned

Tipo de dados

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
Descrição

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

Tipo de dados

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

Similar models

Eligibility End Stage Renal Disease NCT01509937

Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
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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