ID

26237

Description

Very Low Protein Diet and Renal Death in Chronic Kidney Disease (CKD)-ERIKA Study; ODM derived from: https://clinicaltrials.gov/show/NCT00323713

Link

https://clinicaltrials.gov/show/NCT00323713

Keywords

Versions (1)
  1. 10/13/17 10/13/17 -
Copyright Holder

see clinicaltrials.gov

Uploaded on

October 13, 2017

DOI

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License

Creative Commons BY 4.0
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Eligibility Chronic Renal Insufficiency NCT00323713

English

Eligibility Chronic Renal Insufficiency NCT00323713

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
patients with chronic renal insufficiency in stage ckd 4 and 5 (gfr < 30 ml/min/1.73m2, estimated by the 24-hours creatinine clearance) receiving conservative treatment for ckd
Description

Chronic renal insufficiency in stage ckd 4 and 5, receiving conservative treatment

Data type

boolean

Alias
UMLS CUI [1,1]
C0403447
UMLS CUI [1,2]
C0459914
incident patients with chronic renal insufficiency in stage ckd 4 and 5 (gfr < 30 ml/min/1.73m2, estimated by the 24-hours creatinine clearance), provided stable renal function determined by two 24-hour measurements of creatinine clearance 2 weeks a part
Description

Incident patients with chronic renal insufficiency in stage ckd 4 and 5, provided stable renal function

Data type

boolean

Alias
UMLS CUI [1,1]
C0403447
UMLS CUI [1,2]
C0232804
UMLS CUI [1,3]
C0373595
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
patients already on very low protein diet
Description

Very low protein diet

Data type

boolean

Alias
UMLS CUI [1]
C4069273
change of creatinine clearance > 30% within the last 3 months
Description

Change of creatinine clearance within the last 3 months

Data type

boolean

Alias
UMLS CUI [1,1]
C0812399
UMLS CUI [1,2]
C0443172
UMLS CUI [1,3]
C4086725
severe undernutrition as indicated by :
Description

Severe undernutrition

Data type

boolean

Alias
UMLS CUI [1,1]
C0162429
UMLS CUI [1,2]
C0205404
1. bmi < 20 kg/m2 in presence of serum albumin < 3.0 g/dl, or bmi < 17.5 kg/m2 whatever albumin value
Description

BMI and albumin value

Data type

boolean

Alias
UMLS CUI [1,1]
C1305855
UMLS CUI [1,2]
C0001924
2. body weight reduction > 7.5% within the last 3 months
Description

Body weight reduction within the last 3 months

Data type

boolean

Alias
UMLS CUI [1,1]
C1262477
UMLS CUI [1,2]
C4086725
severe obesity as indicated by bmi > 35 kg/m2
Description

Severe obesity indicated by bmi

Data type

boolean

Alias
UMLS CUI [1,1]
C0028756
UMLS CUI [1,2]
C1305855
pregnancy or feeding
Description

Pregnancy or breastfeeding

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
chronic treatment with steroid or cytotoxic drugs
Description

Concomitant medication with steroid or cytotoxic drugs

Data type

boolean

Alias
UMLS CUI [1,1]
C2826666
UMLS CUI [1,2]
C0038317
UMLS CUI [2,1]
C2826666
UMLS CUI [2,2]
C0304497
fast progressing glomerulonephritis
Description

Fast progressing glomerulonephritis

Data type

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C0017658
UMLS CUI [1,3]
C0205329
active sle and vasculitis
Description

Active sle and vasculitis

Data type

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C0024141
UMLS CUI [2,1]
C0009488
UMLS CUI [2,2]
C0042384
cardiac failure stage iv nyha
Description

Cardiac failure stage iv nyha

Data type

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C1536133
advanced liver cirrhosis
Description

Advanced liver cirrhosis

Data type

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C0023890
UMLS CUI [1,3]
C3854260
active cancer diseases
Description

Active cancer diseases

Data type

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C1882062
severe encephalopathy associated with lack of spontaneous feeding
Description

Severe encephalopathy associated with lack of spontaneous feeding

Data type

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C0085584
UMLS CUI [1,3]
C1532663
chronic obstructive respiratory diseases needing oxygen treatment
Description

Chronic obstructive respiratory diseases needing oxygen treatment

Data type

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C0024117
UMLS CUI [1,3]
C0184633
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Similar models

Eligibility Chronic Renal Insufficiency NCT00323713

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Chronic renal insufficiency in stage ckd 4 and 5, receiving conservative treatment
Item
patients with chronic renal insufficiency in stage ckd 4 and 5 (gfr < 30 ml/min/1.73m2, estimated by the 24-hours creatinine clearance) receiving conservative treatment for ckd
boolean
C0403447 (UMLS CUI [1,1])
C0459914 (UMLS CUI [1,2])
Incident patients with chronic renal insufficiency in stage ckd 4 and 5, provided stable renal function
Item
incident patients with chronic renal insufficiency in stage ckd 4 and 5 (gfr < 30 ml/min/1.73m2, estimated by the 24-hours creatinine clearance), provided stable renal function determined by two 24-hour measurements of creatinine clearance 2 weeks a part
boolean
C0403447 (UMLS CUI [1,1])
C0232804 (UMLS CUI [1,2])
C0373595 (UMLS CUI [1,3])
Item Group
C0680251 (UMLS CUI)
Very low protein diet
Item
patients already on very low protein diet
boolean
C4069273 (UMLS CUI [1])
Change of creatinine clearance within the last 3 months
Item
change of creatinine clearance > 30% within the last 3 months
boolean
C0812399 (UMLS CUI [1,1])
C0443172 (UMLS CUI [1,2])
C4086725 (UMLS CUI [1,3])
Severe undernutrition
Item
severe undernutrition as indicated by :
boolean
C0162429 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
BMI and albumin value
Item
1. bmi < 20 kg/m2 in presence of serum albumin < 3.0 g/dl, or bmi < 17.5 kg/m2 whatever albumin value
boolean
C1305855 (UMLS CUI [1,1])
C0001924 (UMLS CUI [1,2])
Body weight reduction within the last 3 months
Item
2. body weight reduction > 7.5% within the last 3 months
boolean
C1262477 (UMLS CUI [1,1])
C4086725 (UMLS CUI [1,2])
Severe obesity indicated by bmi
Item
severe obesity as indicated by bmi > 35 kg/m2
boolean
C0028756 (UMLS CUI [1,1])
C1305855 (UMLS CUI [1,2])
Pregnancy or breastfeeding
Item
pregnancy or feeding
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Concomitant medication with steroid or cytotoxic drugs
Item
chronic treatment with steroid or cytotoxic drugs
boolean
C2826666 (UMLS CUI [1,1])
C0038317 (UMLS CUI [1,2])
C2826666 (UMLS CUI [2,1])
C0304497 (UMLS CUI [2,2])
Fast progressing glomerulonephritis
Item
fast progressing glomerulonephritis
boolean
C0009488 (UMLS CUI [1,1])
C0017658 (UMLS CUI [1,2])
C0205329 (UMLS CUI [1,3])
Active sle and vasculitis
Item
active sle and vasculitis
boolean
C0009488 (UMLS CUI [1,1])
C0024141 (UMLS CUI [1,2])
C0009488 (UMLS CUI [2,1])
C0042384 (UMLS CUI [2,2])
Cardiac failure stage iv nyha
Item
cardiac failure stage iv nyha
boolean
C0009488 (UMLS CUI [1,1])
C1536133 (UMLS CUI [1,2])
Advanced liver cirrhosis
Item
advanced liver cirrhosis
boolean
C0009488 (UMLS CUI [1,1])
C0023890 (UMLS CUI [1,2])
C3854260 (UMLS CUI [1,3])
Active cancer diseases
Item
active cancer diseases
boolean
C0009488 (UMLS CUI [1,1])
C1882062 (UMLS CUI [1,2])
Severe encephalopathy associated with lack of spontaneous feeding
Item
severe encephalopathy associated with lack of spontaneous feeding
boolean
C0009488 (UMLS CUI [1,1])
C0085584 (UMLS CUI [1,2])
C1532663 (UMLS CUI [1,3])
Chronic obstructive respiratory diseases needing oxygen treatment
Item
chronic obstructive respiratory diseases needing oxygen treatment
boolean
C0009488 (UMLS CUI [1,1])
C0024117 (UMLS CUI [1,2])
C0184633 (UMLS CUI [1,3])
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