ID

39257

Description

Blood Volume Analysis and Related Outcomes in Hemodialysis; ODM derived from: https://clinicaltrials.gov/show/NCT01679249

Link

https://clinicaltrials.gov/show/NCT01679249

Keywords

Versions (1)
  1. 12/13/19 12/13/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

December 13, 2019

DOI

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License

Creative Commons BY 4.0
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Eligibility End Stage Kidney Disease NCT01679249

English

Eligibility End Stage Kidney Disease NCT01679249

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
age >21 years
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
primary diagnosis of either chronic or acute kidney disease
Description

Chronic Kidney Disease | Kidney Disease

Data type

boolean

Alias
UMLS CUI [1]
C1561643
UMLS CUI [2]
C0022658
currently receiving hd treatment
Description

Hemodialysis

Data type

boolean

Alias
UMLS CUI [1]
C0019004
thrice-weekly or twice-weekly hd schedule
Description

Hemodialysis Treatment schedule times per week

Data type

boolean

Alias
UMLS CUI [1,1]
C0019004
UMLS CUI [1,2]
C0040808
UMLS CUI [1,3]
C0456698
treated with standard bicarbonate hd for at least the preceding 6 months
Description

Standard Bicarbonate Hemodialysis

Data type

boolean

Alias
UMLS CUI [1,1]
C1442989
UMLS CUI [1,2]
C0005367
UMLS CUI [1,3]
C0019004
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
pregnant women or nursing mothers
Description

Pregnancy | Breast Feeding

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
known hypersensitivity to iodine, eggs, albumin or any other component of the volumex injection kit
Description

Iodine allergy | Allergy to eggs | Hypersensitivity Albumin

Data type

boolean

Alias
UMLS CUI [1]
C0571818
UMLS CUI [2]
C0559469
UMLS CUI [3,1]
C0020517
UMLS CUI [3,2]
C0001924
current enrollment in another investigational treatment protocol for dialysis
Description

Study Subject Participation Status | Treatment Protocol Investigational Dialysis

Data type

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2,1]
C0040808
UMLS CUI [2,2]
C1517586
UMLS CUI [2,3]
C0011946
the need to perform hemodialysis with predilution because this will interfere with measurements of relative blood volume changes (δrbv)
Description

Patient need for Hemodialysis with Pre-Dilution

Data type

boolean

Alias
UMLS CUI [1,1]
C0686904
UMLS CUI [1,2]
C0019004
UMLS CUI [1,3]
C0332287
UMLS CUI [1,4]
C1551349
kidney transplantation
Description

Kidney Transplantation

Data type

boolean

Alias
UMLS CUI [1]
C0022671
malignancy requiring chemotherapy
Description

Malignant Neoplasm Requirement Chemotherapy

Data type

boolean

Alias
UMLS CUI [1,1]
C0006826
UMLS CUI [1,2]
C1514873
UMLS CUI [1,3]
C0392920
unmeasurable blood pressure with a sphygmomanometer
Description

Blood pressure determination Unsuccessful Sphygmomanometer

Data type

boolean

Alias
UMLS CUI [1,1]
C0005824
UMLS CUI [1,2]
C1272705
UMLS CUI [1,3]
C0183427
active hematological disease
Description

Hematological Disease

Data type

boolean

Alias
UMLS CUI [1]
C0018939
active gastrointestinal bleeding
Description

Gastrointestinal Hemorrhage

Data type

boolean

Alias
UMLS CUI [1]
C0017181
severe malnutrition (predialysis serum albumin <2.6 g/dl)
Description

Severe malnutrition | Serum albumin measurement Pre-dialysis

Data type

boolean

Alias
UMLS CUI [1]
C0311276
UMLS CUI [2,1]
C0523465
UMLS CUI [2,2]
C1264634
persistent condition of intradialytic blood pressure instability (hypotensive episodes in >80% of regular dialysis sessions) within the previous one month period
Description

Unstable blood pressure During Hemodialysis | Hypotensive episode Hemodialysis Percentage

Data type

boolean

Alias
UMLS CUI [1,1]
C4540782
UMLS CUI [1,2]
C0347984
UMLS CUI [1,3]
C0019004
UMLS CUI [2,1]
C0520541
UMLS CUI [2,2]
C0019004
UMLS CUI [2,3]
C0439165
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Similar models

Eligibility End Stage Kidney Disease NCT01679249

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
age >21 years
boolean
C0001779 (UMLS CUI [1])
Chronic Kidney Disease | Kidney Disease
Item
primary diagnosis of either chronic or acute kidney disease
boolean
C1561643 (UMLS CUI [1])
C0022658 (UMLS CUI [2])
Hemodialysis
Item
currently receiving hd treatment
boolean
C0019004 (UMLS CUI [1])
Hemodialysis Treatment schedule times per week
Item
thrice-weekly or twice-weekly hd schedule
boolean
C0019004 (UMLS CUI [1,1])
C0040808 (UMLS CUI [1,2])
C0456698 (UMLS CUI [1,3])
Standard Bicarbonate Hemodialysis
Item
treated with standard bicarbonate hd for at least the preceding 6 months
boolean
C1442989 (UMLS CUI [1,1])
C0005367 (UMLS CUI [1,2])
C0019004 (UMLS CUI [1,3])
Item Group
C0680251 (UMLS CUI)
Pregnancy | Breast Feeding
Item
pregnant women or nursing mothers
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Iodine allergy | Allergy to eggs | Hypersensitivity Albumin
Item
known hypersensitivity to iodine, eggs, albumin or any other component of the volumex injection kit
boolean
C0571818 (UMLS CUI [1])
C0559469 (UMLS CUI [2])
C0020517 (UMLS CUI [3,1])
C0001924 (UMLS CUI [3,2])
Study Subject Participation Status | Treatment Protocol Investigational Dialysis
Item
current enrollment in another investigational treatment protocol for dialysis
boolean
C2348568 (UMLS CUI [1])
C0040808 (UMLS CUI [2,1])
C1517586 (UMLS CUI [2,2])
C0011946 (UMLS CUI [2,3])
Patient need for Hemodialysis with Pre-Dilution
Item
the need to perform hemodialysis with predilution because this will interfere with measurements of relative blood volume changes (δrbv)
boolean
C0686904 (UMLS CUI [1,1])
C0019004 (UMLS CUI [1,2])
C0332287 (UMLS CUI [1,3])
C1551349 (UMLS CUI [1,4])
Kidney Transplantation
Item
kidney transplantation
boolean
C0022671 (UMLS CUI [1])
Malignant Neoplasm Requirement Chemotherapy
Item
malignancy requiring chemotherapy
boolean
C0006826 (UMLS CUI [1,1])
C1514873 (UMLS CUI [1,2])
C0392920 (UMLS CUI [1,3])
Blood pressure determination Unsuccessful Sphygmomanometer
Item
unmeasurable blood pressure with a sphygmomanometer
boolean
C0005824 (UMLS CUI [1,1])
C1272705 (UMLS CUI [1,2])
C0183427 (UMLS CUI [1,3])
Hematological Disease
Item
active hematological disease
boolean
C0018939 (UMLS CUI [1])
Gastrointestinal Hemorrhage
Item
active gastrointestinal bleeding
boolean
C0017181 (UMLS CUI [1])
Severe malnutrition | Serum albumin measurement Pre-dialysis
Item
severe malnutrition (predialysis serum albumin <2.6 g/dl)
boolean
C0311276 (UMLS CUI [1])
C0523465 (UMLS CUI [2,1])
C1264634 (UMLS CUI [2,2])
Unstable blood pressure During Hemodialysis | Hypotensive episode Hemodialysis Percentage
Item
persistent condition of intradialytic blood pressure instability (hypotensive episodes in >80% of regular dialysis sessions) within the previous one month period
boolean
C4540782 (UMLS CUI [1,1])
C0347984 (UMLS CUI [1,2])
C0019004 (UMLS CUI [1,3])
C0520541 (UMLS CUI [2,1])
C0019004 (UMLS CUI [2,2])
C0439165 (UMLS CUI [2,3])
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