ID

29289

Description

Investigation of Performance and Compatibility of the Baxter Dialyzer Xenium XPH 210 During On-line Hemodiafiltration; ODM derived from: https://clinicaltrials.gov/show/NCT00976846

Link

https://clinicaltrials.gov/show/NCT00976846

Keywords

  1. 3/15/18 3/15/18 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

March 15, 2018

DOI

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License

Creative Commons BY 4.0

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Eligibility End Stage Kidney Disease NCT00976846

Eligibility End Stage Kidney Disease NCT00976846

Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
patients who have signed an informed consent form.
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
patients between 18 and 75 years.
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
patients who have been treated with hemodialysis for more than three months.
Description

Hemodialysis Duration

Data type

boolean

Alias
UMLS CUI [1,1]
C0019004
UMLS CUI [1,2]
C0449238
patients who are treated three times a week for 4-5 hours.
Description

Therapeutic procedure Frequency Duration

Data type

boolean

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C0439603
UMLS CUI [1,3]
C0449238
patients who are usually treated with high-flux dialyzers.
Description

Dialyzers, High-Flux

Data type

boolean

Alias
UMLS CUI [1]
C3688647
patients who are on a stable anticoagulation and erythropoetin regimen.
Description

Anticoagulation Therapy Stable | Erythropoietin Stable

Data type

boolean

Alias
UMLS CUI [1,1]
C0003281
UMLS CUI [1,2]
C0205360
UMLS CUI [2,1]
C0014822
UMLS CUI [2,2]
C0205360
patients whose hematocrit is over 28 %.
Description

Hematocrit level

Data type

boolean

Alias
UMLS CUI [1]
C0518014
patients having no vascular access related problems.
Description

Vascular access Problem Absent

Data type

boolean

Alias
UMLS CUI [1,1]
C0750138
UMLS CUI [1,2]
C0033213
UMLS CUI [1,3]
C0332197
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
patients not meeting the inclusion criteria.
Description

Inclusion criteria Mismatch

Data type

boolean

Alias
UMLS CUI [1,1]
C1512693
UMLS CUI [1,2]
C1881865
patients who are in a poor nutritional status as judged by the investigator.
Description

Nutritional status Poor

Data type

boolean

Alias
UMLS CUI [1,1]
C0392209
UMLS CUI [1,2]
C0542537
patients in a gravid state.
Description

Pregnancy

Data type

boolean

Alias
UMLS CUI [1]
C0032961
patients with an unstable clinical condition (e.g. cardiac or vascular instability).
Description

Medical condition Unstable | Instability cardiac | Instability Vascular

Data type

boolean

Alias
UMLS CUI [1,1]
C3843040
UMLS CUI [1,2]
C0443343
UMLS CUI [2,1]
C1444783
UMLS CUI [2,2]
C0018787
UMLS CUI [3,1]
C1444783
UMLS CUI [3,2]
C1801960
patients whose life expectancy is less than 12 months.
Description

Life Expectancy

Data type

boolean

Alias
UMLS CUI [1]
C0023671
patients with a positive anamnesis for the first use syndrome.
Description

Anamnesis Positive First use syndrome

Data type

boolean

Alias
UMLS CUI [1,1]
C0025084
UMLS CUI [1,2]
C1514241
UMLS CUI [1,3]
C1707736
patients with known coagulation problems.
Description

Blood Coagulation Disorders

Data type

boolean

Alias
UMLS CUI [1]
C0005779
patients who receive hemodialysis via a single dialysis needle or central venous catheter.
Description

Hemodialysis Needle Single | Hemodialysis Central venous catheter

Data type

boolean

Alias
UMLS CUI [1,1]
C0019004
UMLS CUI [1,2]
C0027551
UMLS CUI [1,3]
C0205171
UMLS CUI [2,1]
C0019004
UMLS CUI [2,2]
C1145640
patients participating in another study that may interfere with the outcome of the present study.
Description

Study Subject Participation Status Interferes with Research results

Data type

boolean

Alias
UMLS CUI [1,1]
C2348568
UMLS CUI [1,2]
C0521102
UMLS CUI [1,3]
C0683954

Similar models

Eligibility End Stage Kidney Disease NCT00976846

Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Informed Consent
Item
patients who have signed an informed consent form.
boolean
C0021430 (UMLS CUI [1])
Age
Item
patients between 18 and 75 years.
boolean
C0001779 (UMLS CUI [1])
Hemodialysis Duration
Item
patients who have been treated with hemodialysis for more than three months.
boolean
C0019004 (UMLS CUI [1,1])
C0449238 (UMLS CUI [1,2])
Therapeutic procedure Frequency Duration
Item
patients who are treated three times a week for 4-5 hours.
boolean
C0087111 (UMLS CUI [1,1])
C0439603 (UMLS CUI [1,2])
C0449238 (UMLS CUI [1,3])
Dialyzers, High-Flux
Item
patients who are usually treated with high-flux dialyzers.
boolean
C3688647 (UMLS CUI [1])
Anticoagulation Therapy Stable | Erythropoietin Stable
Item
patients who are on a stable anticoagulation and erythropoetin regimen.
boolean
C0003281 (UMLS CUI [1,1])
C0205360 (UMLS CUI [1,2])
C0014822 (UMLS CUI [2,1])
C0205360 (UMLS CUI [2,2])
Hematocrit level
Item
patients whose hematocrit is over 28 %.
boolean
C0518014 (UMLS CUI [1])
Vascular access Problem Absent
Item
patients having no vascular access related problems.
boolean
C0750138 (UMLS CUI [1,1])
C0033213 (UMLS CUI [1,2])
C0332197 (UMLS CUI [1,3])
Item Group
C0680251 (UMLS CUI)
Inclusion criteria Mismatch
Item
patients not meeting the inclusion criteria.
boolean
C1512693 (UMLS CUI [1,1])
C1881865 (UMLS CUI [1,2])
Nutritional status Poor
Item
patients who are in a poor nutritional status as judged by the investigator.
boolean
C0392209 (UMLS CUI [1,1])
C0542537 (UMLS CUI [1,2])
Pregnancy
Item
patients in a gravid state.
boolean
C0032961 (UMLS CUI [1])
Medical condition Unstable | Instability cardiac | Instability Vascular
Item
patients with an unstable clinical condition (e.g. cardiac or vascular instability).
boolean
C3843040 (UMLS CUI [1,1])
C0443343 (UMLS CUI [1,2])
C1444783 (UMLS CUI [2,1])
C0018787 (UMLS CUI [2,2])
C1444783 (UMLS CUI [3,1])
C1801960 (UMLS CUI [3,2])
Life Expectancy
Item
patients whose life expectancy is less than 12 months.
boolean
C0023671 (UMLS CUI [1])
Anamnesis Positive First use syndrome
Item
patients with a positive anamnesis for the first use syndrome.
boolean
C0025084 (UMLS CUI [1,1])
C1514241 (UMLS CUI [1,2])
C1707736 (UMLS CUI [1,3])
Blood Coagulation Disorders
Item
patients with known coagulation problems.
boolean
C0005779 (UMLS CUI [1])
Hemodialysis Needle Single | Hemodialysis Central venous catheter
Item
patients who receive hemodialysis via a single dialysis needle or central venous catheter.
boolean
C0019004 (UMLS CUI [1,1])
C0027551 (UMLS CUI [1,2])
C0205171 (UMLS CUI [1,3])
C0019004 (UMLS CUI [2,1])
C1145640 (UMLS CUI [2,2])
Study Subject Participation Status Interferes with Research results
Item
patients participating in another study that may interfere with the outcome of the present study.
boolean
C2348568 (UMLS CUI [1,1])
C0521102 (UMLS CUI [1,2])
C0683954 (UMLS CUI [1,3])

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