ID

39155

Description

Evaluation of Daily HemoDialysis at Low Dialysate Flow in Patients Previously Treated With Conventional Hemodialysis; ODM derived from: https://clinicaltrials.gov/show/NCT01845012

Link

https://clinicaltrials.gov/show/NCT01845012

Keywords

Versions (1)
  1. 12/5/19 12/5/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

December 5, 2019

DOI

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License

Creative Commons BY 4.0
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Eligibility End Stage Renal Disease NCT01845012

English

Eligibility End Stage Renal Disease NCT01845012

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
age ≥ 18 years
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
patients who give voluntary signed informed consent
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
patients affiliated with the french universal health care system or similar
Description

Patients Affiliated Health Care System

Data type

boolean

Alias
UMLS CUI [1,1]
C0030705
UMLS CUI [1,2]
C1510825
UMLS CUI [1,3]
C0018696
for women of childbearing potential: serum or urine negative pregnancy test
Description

Childbearing Potential Serum pregnancy test negative | Childbearing Potential Urine pregnancy test negative

Data type

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0430061
UMLS CUI [2,1]
C3831118
UMLS CUI [2,2]
C0430057
patients treated with conventional hemodialysis (3 times 4h to 5h per week at at least a dialysate flow rate of 500 ml/min) for at least 3 months and clinically stable (investigator assessment)
Description

Hemodialysis times per week | Dialysate Flow Rate

Data type

boolean

Alias
UMLS CUI [1,1]
C0019004
UMLS CUI [1,2]
C0456698
UMLS CUI [2,1]
C0011947
UMLS CUI [2,2]
C2826285
bipuncture patients (or with double lumen central venous catheter) with stable vascular access and easy to puncture
Description

Puncture of vessel | Central venous catheter Double lumen | Vascular access Stable

Data type

boolean

Alias
UMLS CUI [1]
C0176672
UMLS CUI [2,1]
C1145640
UMLS CUI [2,2]
C0441131
UMLS CUI [3,1]
C0750138
UMLS CUI [3,2]
C0205360
patients willing to be treated with daily hemodialysis at low dialysate flow during the study period (6 times 2h to 2h30 per week at a dialysate flow rate of 200 ml/min in order that the total duration of weekly dialysis is equivalent to the duration of weekly dialysis during the last 3 months of conventional hemodialysis)
Description

Hemodialysis Daily | Dialysate Flow Rate low

Data type

boolean

Alias
UMLS CUI [1,1]
C0019004
UMLS CUI [1,2]
C0332173
UMLS CUI [2,1]
C0011947
UMLS CUI [2,2]
C2826285
UMLS CUI [2,3]
C0205251
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
pregnant women or women who could become pregnant during the study (planned pregnancy within 3 months)
Description

Pregnancy | Pregnancy, Planned

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0032992
patients not affiliated with the french universal health care system
Description

Affiliation Health Care System Lacking

Data type

boolean

Alias
UMLS CUI [1,1]
C1510825
UMLS CUI [1,2]
C0018696
UMLS CUI [1,3]
C0332268
minor patients
Description

Minor Patients

Data type

boolean

Alias
UMLS CUI [1,1]
C0026193
UMLS CUI [1,2]
C0030705
patients who are protected adults according to the terms of the law (french public health laws).
Description

Protection of patient Law

Data type

boolean

Alias
UMLS CUI [1,1]
C0412786
UMLS CUI [1,2]
C0220866
refusal to give consent
Description

Informed Consent Refused

Data type

boolean

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C1705116
patients simultaneously participating in another trial that may interfere with the study results
Description

Study Subject Participation Status | Interference Research results

Data type

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2,1]
C0521102
UMLS CUI [2,2]
C0683954
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Similar models

Eligibility End Stage Renal Disease NCT01845012

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
age ≥ 18 years
boolean
C0001779 (UMLS CUI [1])
Informed Consent
Item
patients who give voluntary signed informed consent
boolean
C0021430 (UMLS CUI [1])
Patients Affiliated Health Care System
Item
patients affiliated with the french universal health care system or similar
boolean
C0030705 (UMLS CUI [1,1])
C1510825 (UMLS CUI [1,2])
C0018696 (UMLS CUI [1,3])
Childbearing Potential Serum pregnancy test negative | Childbearing Potential Urine pregnancy test negative
Item
for women of childbearing potential: serum or urine negative pregnancy test
boolean
C3831118 (UMLS CUI [1,1])
C0430061 (UMLS CUI [1,2])
C3831118 (UMLS CUI [2,1])
C0430057 (UMLS CUI [2,2])
Hemodialysis times per week | Dialysate Flow Rate
Item
patients treated with conventional hemodialysis (3 times 4h to 5h per week at at least a dialysate flow rate of 500 ml/min) for at least 3 months and clinically stable (investigator assessment)
boolean
C0019004 (UMLS CUI [1,1])
C0456698 (UMLS CUI [1,2])
C0011947 (UMLS CUI [2,1])
C2826285 (UMLS CUI [2,2])
Puncture of vessel | Central venous catheter Double lumen | Vascular access Stable
Item
bipuncture patients (or with double lumen central venous catheter) with stable vascular access and easy to puncture
boolean
C0176672 (UMLS CUI [1])
C1145640 (UMLS CUI [2,1])
C0441131 (UMLS CUI [2,2])
C0750138 (UMLS CUI [3,1])
C0205360 (UMLS CUI [3,2])
Hemodialysis Daily | Dialysate Flow Rate low
Item
patients willing to be treated with daily hemodialysis at low dialysate flow during the study period (6 times 2h to 2h30 per week at a dialysate flow rate of 200 ml/min in order that the total duration of weekly dialysis is equivalent to the duration of weekly dialysis during the last 3 months of conventional hemodialysis)
boolean
C0019004 (UMLS CUI [1,1])
C0332173 (UMLS CUI [1,2])
C0011947 (UMLS CUI [2,1])
C2826285 (UMLS CUI [2,2])
C0205251 (UMLS CUI [2,3])
Item Group
C0680251 (UMLS CUI)
Pregnancy | Pregnancy, Planned
Item
pregnant women or women who could become pregnant during the study (planned pregnancy within 3 months)
boolean
C0032961 (UMLS CUI [1])
C0032992 (UMLS CUI [2])
Affiliation Health Care System Lacking
Item
patients not affiliated with the french universal health care system
boolean
C1510825 (UMLS CUI [1,1])
C0018696 (UMLS CUI [1,2])
C0332268 (UMLS CUI [1,3])
Minor Patients
Item
minor patients
boolean
C0026193 (UMLS CUI [1,1])
C0030705 (UMLS CUI [1,2])
Protection of patient Law
Item
patients who are protected adults according to the terms of the law (french public health laws).
boolean
C0412786 (UMLS CUI [1,1])
C0220866 (UMLS CUI [1,2])
Informed Consent Refused
Item
refusal to give consent
boolean
C0021430 (UMLS CUI [1,1])
C1705116 (UMLS CUI [1,2])
Study Subject Participation Status | Interference Research results
Item
patients simultaneously participating in another trial that may interfere with the study results
boolean
C2348568 (UMLS CUI [1])
C0521102 (UMLS CUI [2,1])
C0683954 (UMLS CUI [2,2])
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