ID

42559

Description

Arterial pH and N-balances in APD; ODM derived from: https://clinicaltrials.gov/show/NCT00586131

Link

https://clinicaltrials.gov/show/NCT00586131

Keywords

Versions (2)
  1. 9/9/16 9/9/16 -
  2. 9/2/21 9/2/21 -
Uploaded on

September 2, 2021

DOI

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License

Creative Commons BY 4.0
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Eligibility End-stage Renal Disease NCT00586131

English

Eligibility End-stage Renal Disease NCT00586131

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. men and women from any ethnic/racial group < 65 years.
Description

Age | Ethnic group Any | Racial group Any

Data type

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2,1]
C0015031
UMLS CUI [2,2]
C1552551
UMLS CUI [3,1]
C0034510
UMLS CUI [3,2]
C1552551
2. treatment with cpd for 6 months and current treatment with apd for at least one month.
Description

Continuous Peritoneal Dialysis Duration | Automated peritoneal dialysis Duration

Data type

boolean

Alias
UMLS CUI [1,1]
C0031139
UMLS CUI [1,2]
C0549178
UMLS CUI [1,3]
C0449238
UMLS CUI [2,1]
C1997821
UMLS CUI [2,2]
C0449238
3. hemoglobin of at least 11.0 g/dl.
Description

Hemoglobin

Data type

boolean

Alias
UMLS CUI [1]
C0019046
4. stable dose of erythropoietin treatment for at least the preceding three months.
Description

Erythropoietin Dose Stable

Data type

boolean

Alias
UMLS CUI [1,1]
C0014822
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C0205360
5. subjects with normal nutritional status to mild malnutrition:
Description

Nutritional condition normal | malnutrition; mild

Data type

boolean

Alias
UMLS CUI [1]
C1608413
UMLS CUI [2]
C1408552
1. serum albumin > 3.3 g/dl
Description

Serum albumin measurement

Data type

boolean

Alias
UMLS CUI [1]
C0523465
2. relative body weight of 90-120% of the nhanes ii median body weight for a given height, age range, gender and frame size.
Description

Body Weight Relative to Body Weight Median | NHANES | Body Height | Age Range | Gender | body frame size

Data type

boolean

Alias
UMLS CUI [1,1]
C0005910
UMLS CUI [1,2]
C3875154
UMLS CUI [1,3]
C0005910
UMLS CUI [1,4]
C0876920
UMLS CUI [2]
C0376344
UMLS CUI [3]
C0005890
UMLS CUI [4,1]
C0001779
UMLS CUI [4,2]
C1514721
UMLS CUI [5]
C0079399
UMLS CUI [6]
C1706977
3. a normalized protein equivalent of total nitrogen appearance (npna) > 0.80 g/kg actual body weight/day at the time of screening.
Description

Catabolic protein rate Normalized | Body Weight

Data type

boolean

Alias
UMLS CUI [1,1]
C3483169
UMLS CUI [1,2]
C1882115
UMLS CUI [2]
C0005910
6. d/p cr between 0.48 and 0.81 on the pet performed at the time of the screen.
Description

Dialysate Plasma Ratio Creatinine | Peritoneal equilibration test

Data type

boolean

Alias
UMLS CUI [1,1]
C0011947
UMLS CUI [1,2]
C0032105
UMLS CUI [1,3]
C0456603
UMLS CUI [1,4]
C0010294
UMLS CUI [2]
C0430949
7. total (renal + peritoneal) weekly kt/v urea > 1.70 and creatinine clearance > 50 l/wk/1.73 m2.
Description

kt/V Urea Weekly renal | kt/V Urea Weekly peritoneal | Creatinine clearance measurement

Data type

boolean

Alias
UMLS CUI [1,1]
C0429662
UMLS CUI [1,2]
C0041942
UMLS CUI [1,3]
C0332174
UMLS CUI [1,4]
C0022646
UMLS CUI [2,1]
C0429662
UMLS CUI [2,2]
C0041942
UMLS CUI [2,3]
C0332174
UMLS CUI [2,4]
C0442034
UMLS CUI [3]
C0373595
8. no evidence of primary or secondary (viz., ischemic, neuropathic) myopathy
Description

Primary myopathy Evidence | Secondary myopathy Evidence | Myopathy Ischemic | Myopathy Related Neuropathy

Data type

boolean

Alias
UMLS CUI [1,1]
C0494503
UMLS CUI [1,2]
C3887511
UMLS CUI [2,1]
C0270992
UMLS CUI [2,2]
C3887511
UMLS CUI [3,1]
C0026848
UMLS CUI [3,2]
C0475224
UMLS CUI [4,1]
C0026848
UMLS CUI [4,2]
C0439849
UMLS CUI [4,3]
C0442874
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. history of active cancer other than basal cell carcinoma.
Description

Malignant Neoplasms | Basal cell carcinoma

Data type

boolean

Alias
UMLS CUI [1]
C0006826
UMLS CUI [2]
C0007117
2. symptomatic severe ischemic heart disease, uncontrolled severe dysrhythmias, uncontrolled congestive heart failure, poorly controlled hypertension, severe musculoskeletal disease, arthritis or amputation of the lower extremities.
Description

Myocardial Ischemia Severe Symptomatic | Cardiac Arrhythmia Severe Uncontrolled | Congestive heart failure Uncontrolled | Hypertensive disease Poorly controlled | Musculoskeletal Diseases Severe | Arthritis | Amputation of lower limb

Data type

boolean

Alias
UMLS CUI [1,1]
C0151744
UMLS CUI [1,2]
C0205082
UMLS CUI [1,3]
C0231220
UMLS CUI [2,1]
C0003811
UMLS CUI [2,2]
C0205082
UMLS CUI [2,3]
C0205318
UMLS CUI [3,1]
C0018802
UMLS CUI [3,2]
C0205318
UMLS CUI [4,1]
C0020538
UMLS CUI [4,2]
C3853134
UMLS CUI [5,1]
C0026857
UMLS CUI [5,2]
C0205082
UMLS CUI [6]
C0003864
UMLS CUI [7]
C0337308
3. insulin requiring diabetes mellitus.
Description

Diabetes Mellitus, Insulin-Dependent

Data type

boolean

Alias
UMLS CUI [1]
C0011854
4. patients who received l-carnitine or anabolic hormones (other than erythropoietin) within the previous 6 months.
Description

Levocarnitine | Anabolic steroids | Erythropoietin

Data type

boolean

Alias
UMLS CUI [1]
C0087163
UMLS CUI [2]
C0002845
UMLS CUI [3]
C0014822
5. use of caco3 as phosphate binder.
Description

Calcium Carbonate | Phosphate Binder

Data type

boolean

Alias
UMLS CUI [1]
C0006681
UMLS CUI [2]
C2267031
6. severe lung or liver disease, uncontrolled asthma, active vasculitis.
Description

Lung disease Severe | Liver disease Severe | Asthma Uncontrolled | Vasculitis

Data type

boolean

Alias
UMLS CUI [1,1]
C0024115
UMLS CUI [1,2]
C0205082
UMLS CUI [2,1]
C0023895
UMLS CUI [2,2]
C0205082
UMLS CUI [3,1]
C0004096
UMLS CUI [3,2]
C0205318
UMLS CUI [4]
C0042384
7. severe chronic infection or any other acute or chronic inflammatory or catabolic illnesses (e.g., active tuberculosis, aids, osteomyelitis).
Description

Chronic infectious disease Severe | Inflammatory disorder | Disease catabolic | Tuberculosis | Acquired Immunodeficiency Syndrome | Osteomyelitis

Data type

boolean

Alias
UMLS CUI [1,1]
C0151317
UMLS CUI [1,2]
C0205082
UMLS CUI [2]
C1290884
UMLS CUI [3,1]
C0012634
UMLS CUI [3,2]
C0543484
UMLS CUI [4]
C0041296
UMLS CUI [5]
C0001175
UMLS CUI [6]
C0029443
8. psychosis, inability to give informed consent, evidence that patient will not comply with study protocol.
Description

Psychotic Disorders | Informed Consent Unable | Protocol Compliance Limited

Data type

boolean

Alias
UMLS CUI [1]
C0033975
UMLS CUI [2,1]
C0021430
UMLS CUI [2,2]
C1299582
UMLS CUI [3,1]
C0525058
UMLS CUI [3,2]
C0439801
9. alcohol or other recreational drug abuse.
Description

Substance Use Disorders

Data type

boolean

Alias
UMLS CUI [1]
C0038586
10. pregnancy (rare in cpd patients).
Description

Pregnancy

Data type

boolean

Alias
UMLS CUI [1]
C0032961
11. patients who are physically and/or psychologically incapable of undergoing the protocol.
Description

Protocol Compliance incapable

Data type

boolean

Alias
UMLS CUI [1,1]
C0525058
UMLS CUI [1,2]
C1550518
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Similar models

Eligibility End-stage Renal Disease NCT00586131

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Age | Ethnic group Any | Racial group Any
Item
1. men and women from any ethnic/racial group < 65 years.
boolean
C0001779 (UMLS CUI [1])
C0015031 (UMLS CUI [2,1])
C1552551 (UMLS CUI [2,2])
C0034510 (UMLS CUI [3,1])
C1552551 (UMLS CUI [3,2])
Continuous Peritoneal Dialysis Duration | Automated peritoneal dialysis Duration
Item
2. treatment with cpd for 6 months and current treatment with apd for at least one month.
boolean
C0031139 (UMLS CUI [1,1])
C0549178 (UMLS CUI [1,2])
C0449238 (UMLS CUI [1,3])
C1997821 (UMLS CUI [2,1])
C0449238 (UMLS CUI [2,2])
Hemoglobin
Item
3. hemoglobin of at least 11.0 g/dl.
boolean
C0019046 (UMLS CUI [1])
Erythropoietin Dose Stable
Item
4. stable dose of erythropoietin treatment for at least the preceding three months.
boolean
C0014822 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0205360 (UMLS CUI [1,3])
Nutritional condition normal | malnutrition; mild
Item
5. subjects with normal nutritional status to mild malnutrition:
boolean
C1608413 (UMLS CUI [1])
C1408552 (UMLS CUI [2])
Serum albumin measurement
Item
1. serum albumin > 3.3 g/dl
boolean
C0523465 (UMLS CUI [1])
Body Weight Relative to Body Weight Median | NHANES | Body Height | Age Range | Gender | body frame size
Item
2. relative body weight of 90-120% of the nhanes ii median body weight for a given height, age range, gender and frame size.
boolean
C0005910 (UMLS CUI [1,1])
C3875154 (UMLS CUI [1,2])
C0005910 (UMLS CUI [1,3])
C0876920 (UMLS CUI [1,4])
C0376344 (UMLS CUI [2])
C0005890 (UMLS CUI [3])
C0001779 (UMLS CUI [4,1])
C1514721 (UMLS CUI [4,2])
C0079399 (UMLS CUI [5])
C1706977 (UMLS CUI [6])
Catabolic protein rate Normalized | Body Weight
Item
3. a normalized protein equivalent of total nitrogen appearance (npna) > 0.80 g/kg actual body weight/day at the time of screening.
boolean
C3483169 (UMLS CUI [1,1])
C1882115 (UMLS CUI [1,2])
C0005910 (UMLS CUI [2])
Dialysate Plasma Ratio Creatinine | Peritoneal equilibration test
Item
6. d/p cr between 0.48 and 0.81 on the pet performed at the time of the screen.
boolean
C0011947 (UMLS CUI [1,1])
C0032105 (UMLS CUI [1,2])
C0456603 (UMLS CUI [1,3])
C0010294 (UMLS CUI [1,4])
C0430949 (UMLS CUI [2])
kt/V Urea Weekly renal | kt/V Urea Weekly peritoneal | Creatinine clearance measurement
Item
7. total (renal + peritoneal) weekly kt/v urea > 1.70 and creatinine clearance > 50 l/wk/1.73 m2.
boolean
C0429662 (UMLS CUI [1,1])
C0041942 (UMLS CUI [1,2])
C0332174 (UMLS CUI [1,3])
C0022646 (UMLS CUI [1,4])
C0429662 (UMLS CUI [2,1])
C0041942 (UMLS CUI [2,2])
C0332174 (UMLS CUI [2,3])
C0442034 (UMLS CUI [2,4])
C0373595 (UMLS CUI [3])
Primary myopathy Evidence | Secondary myopathy Evidence | Myopathy Ischemic | Myopathy Related Neuropathy
Item
8. no evidence of primary or secondary (viz., ischemic, neuropathic) myopathy
boolean
C0494503 (UMLS CUI [1,1])
C3887511 (UMLS CUI [1,2])
C0270992 (UMLS CUI [2,1])
C3887511 (UMLS CUI [2,2])
C0026848 (UMLS CUI [3,1])
C0475224 (UMLS CUI [3,2])
C0026848 (UMLS CUI [4,1])
C0439849 (UMLS CUI [4,2])
C0442874 (UMLS CUI [4,3])
Item Group
C0680251 (UMLS CUI)
Malignant Neoplasms | Basal cell carcinoma
Item
1. history of active cancer other than basal cell carcinoma.
boolean
C0006826 (UMLS CUI [1])
C0007117 (UMLS CUI [2])
Myocardial Ischemia Severe Symptomatic | Cardiac Arrhythmia Severe Uncontrolled | Congestive heart failure Uncontrolled | Hypertensive disease Poorly controlled | Musculoskeletal Diseases Severe | Arthritis | Amputation of lower limb
Item
2. symptomatic severe ischemic heart disease, uncontrolled severe dysrhythmias, uncontrolled congestive heart failure, poorly controlled hypertension, severe musculoskeletal disease, arthritis or amputation of the lower extremities.
boolean
C0151744 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C0231220 (UMLS CUI [1,3])
C0003811 (UMLS CUI [2,1])
C0205082 (UMLS CUI [2,2])
C0205318 (UMLS CUI [2,3])
C0018802 (UMLS CUI [3,1])
C0205318 (UMLS CUI [3,2])
C0020538 (UMLS CUI [4,1])
C3853134 (UMLS CUI [4,2])
C0026857 (UMLS CUI [5,1])
C0205082 (UMLS CUI [5,2])
C0003864 (UMLS CUI [6])
C0337308 (UMLS CUI [7])
Diabetes Mellitus, Insulin-Dependent
Item
3. insulin requiring diabetes mellitus.
boolean
C0011854 (UMLS CUI [1])
Levocarnitine | Anabolic steroids | Erythropoietin
Item
4. patients who received l-carnitine or anabolic hormones (other than erythropoietin) within the previous 6 months.
boolean
C0087163 (UMLS CUI [1])
C0002845 (UMLS CUI [2])
C0014822 (UMLS CUI [3])
Calcium Carbonate | Phosphate Binder
Item
5. use of caco3 as phosphate binder.
boolean
C0006681 (UMLS CUI [1])
C2267031 (UMLS CUI [2])
Lung disease Severe | Liver disease Severe | Asthma Uncontrolled | Vasculitis
Item
6. severe lung or liver disease, uncontrolled asthma, active vasculitis.
boolean
C0024115 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C0023895 (UMLS CUI [2,1])
C0205082 (UMLS CUI [2,2])
C0004096 (UMLS CUI [3,1])
C0205318 (UMLS CUI [3,2])
C0042384 (UMLS CUI [4])
Chronic infectious disease Severe | Inflammatory disorder | Disease catabolic | Tuberculosis | Acquired Immunodeficiency Syndrome | Osteomyelitis
Item
7. severe chronic infection or any other acute or chronic inflammatory or catabolic illnesses (e.g., active tuberculosis, aids, osteomyelitis).
boolean
C0151317 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C1290884 (UMLS CUI [2])
C0012634 (UMLS CUI [3,1])
C0543484 (UMLS CUI [3,2])
C0041296 (UMLS CUI [4])
C0001175 (UMLS CUI [5])
C0029443 (UMLS CUI [6])
Psychotic Disorders | Informed Consent Unable | Protocol Compliance Limited
Item
8. psychosis, inability to give informed consent, evidence that patient will not comply with study protocol.
boolean
C0033975 (UMLS CUI [1])
C0021430 (UMLS CUI [2,1])
C1299582 (UMLS CUI [2,2])
C0525058 (UMLS CUI [3,1])
C0439801 (UMLS CUI [3,2])
Substance Use Disorders
Item
9. alcohol or other recreational drug abuse.
boolean
C0038586 (UMLS CUI [1])
Pregnancy
Item
10. pregnancy (rare in cpd patients).
boolean
C0032961 (UMLS CUI [1])
Protocol Compliance incapable
Item
11. patients who are physically and/or psychologically incapable of undergoing the protocol.
boolean
C0525058 (UMLS CUI [1,1])
C1550518 (UMLS CUI [1,2])
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