ID

29585

Description

Protein Intake, Nutrition and Cardiovascular Diseases in Stage V CKD; ODM derived from: https://clinicaltrials.gov/show/NCT00566670

Link

https://clinicaltrials.gov/show/NCT00566670

Keywords

Versions (2)
  1. 4/8/18 4/8/18 -
  2. 4/8/18 4/8/18 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

April 8, 2018

DOI

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License

Creative Commons BY 4.0
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Eligibility Hemodialysis NCT00566670

English

Eligibility Hemodialysis NCT00566670

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
the study will be comprised of adult (≥18 years) chronic hemodialysis patients.
Description

Adult | Age | Chronic haemodialysis

Data type

boolean

Alias
UMLS CUI [1]
C0001675
UMLS CUI [2]
C0001779
UMLS CUI [3]
C1740835
appetite often change with initiation of dialysis and kidney function recover sometimes from acute renal failure; hence only patients on dialysis at least for three months will be included.
Description

Altered appetite Associated with Initiation Dialysis | Renal function Recovering from Kidney Failure | Patients Dialysis

Data type

boolean

Alias
UMLS CUI [1,1]
C0426587
UMLS CUI [1,2]
C0332281
UMLS CUI [1,3]
C1704686
UMLS CUI [1,4]
C0011946
UMLS CUI [2,1]
C0232804
UMLS CUI [2,2]
C0521108
UMLS CUI [2,3]
C0035078
UMLS CUI [3,1]
C0030705
UMLS CUI [3,2]
C0011946
as urinary losses of urea could affect the estimation of protein intake from the urea kinetic modeling, we initially planned to exclude patients with urine output > 200 ml/day. however, this might exclude many potential participants. therefore, we plan to include those participants with upo > 200 ml/day but willing to collect 44-hr urine collection between dialysis treatments for measurement of urinary urea.
Description

Urine volume function mL/day | Urine Collection Urea measurement urinary

Data type

boolean

Alias
UMLS CUI [1,1]
C0232856
UMLS CUI [1,2]
C0439446
UMLS CUI [2,1]
C0200354
UMLS CUI [2,2]
C0523961
UMLS CUI [2,3]
C1524119
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
patients with persistent volume overload (substantial pedal edema) despite attempts at achieving dry weight will be excluded as hydration status might affect estimation of muscle mass. -
Description

Fluid overload persistent | Pedal edema Severe | Hydration status Affecting Estimation Muscle mass

Data type

boolean

Alias
UMLS CUI [1,1]
C0546817
UMLS CUI [1,2]
C0205322
UMLS CUI [2,1]
C0574002
UMLS CUI [2,2]
C0205082
UMLS CUI [3,1]
C1321013
UMLS CUI [3,2]
C0392760
UMLS CUI [3,3]
C0750572
UMLS CUI [3,4]
C0240417
patients with inability to walk or those who use wheel-chair might have reduced mid-thigh muscle mass despite good protein intake because of disuse, and hence these patients will be excluded.
Description

Unable to walk | Wheelchair bound | Reduced muscle mass Mid thigh Due to Disuse | Protein intake Good

Data type

boolean

Alias
UMLS CUI [1]
C0560046
UMLS CUI [2]
C0558195
UMLS CUI [3,1]
C1849578
UMLS CUI [3,2]
C1288637
UMLS CUI [3,3]
C0678226
UMLS CUI [3,4]
C4062565
UMLS CUI [4,1]
C0489617
UMLS CUI [4,2]
C0205170
persons with pacemakers and cochlear implants are excluded because of the magnetic field of mri. certain types of materials used in breast augmentation could be affected by the strong magnetic field and hence breast augmentation is an exclusion criteria. artificial hips could interfere with mid-thigh muscle mass measurements whereas lumbar spine hardware could interfere with visceral fat measurements and hence, individuals with these will be excluded.-
Description

Artificial cardiac pacemaker | Cochlear Implants | Augmentation mammoplasty | Hip Implant Interferes with Mid thigh Muscle mass Measurement | Lumbar spine Hardware Interferes with Visceral Fat Measurement

Data type

boolean

Alias
UMLS CUI [1]
C0030163
UMLS CUI [2]
C0009199
UMLS CUI [3]
C0191925
UMLS CUI [4,1]
C0019560
UMLS CUI [4,2]
C0521102
UMLS CUI [4,3]
C1288637
UMLS CUI [4,4]
C0240417
UMLS CUI [4,5]
C0242485
UMLS CUI [5,1]
C3887615
UMLS CUI [5,2]
C0336577
UMLS CUI [5,3]
C0521102
UMLS CUI [5,4]
C1563740
UMLS CUI [5,5]
C0242485
persons > 300 lbs will be excluded because of the weight limit of the mri table. atrial fibrillation could interfere with measurement of pwv.
Description

Body Weight Pounds | Atrial Fibrillation Interferes with Pulse Wave Velocity Measurement

Data type

boolean

Alias
UMLS CUI [1,1]
C0005910
UMLS CUI [1,2]
C0439219
UMLS CUI [2,1]
C0004238
UMLS CUI [2,2]
C0521102
UMLS CUI [2,3]
C3494431
UMLS CUI [2,4]
C0242485
patients who are unlikely or unable (in the opinion of the nephrologists, nurses or dieticians taking care of the patient) to comply with research protocol will be excluded.
Description

Protocol Compliance Unlikely | Protocol Compliance Unable

Data type

boolean

Alias
UMLS CUI [1,1]
C0525058
UMLS CUI [1,2]
C0750558
UMLS CUI [2,1]
C0525058
UMLS CUI [2,2]
C1299582
patients with symptomatic heart failure, current active malignancy (excluding squamous and basal cell skin cancers), active aids, chronic lung disease requiring supplemental oxygen therapy and cirrhosis will be excluded.
Description

Heart failure Symptomatic | Malignant Neoplasms | Exception Squamous cell carcinoma of skin | Exception Basal cell carcinoma | Acquired Immunodeficiency Syndrome | Chronic lung disease Requirement Oxygen Therapy Care | Liver Cirrhosis

Data type

boolean

Alias
UMLS CUI [1,1]
C0018801
UMLS CUI [1,2]
C0231220
UMLS CUI [2]
C0006826
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0553723
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C0007117
UMLS CUI [5]
C0001175
UMLS CUI [6,1]
C0746102
UMLS CUI [6,2]
C1514873
UMLS CUI [6,3]
C0184633
UMLS CUI [7]
C0023890
patients enrolled in interventional trials will be excluded.
Description

Study Subject Participation Status | Interventional procedure

Data type

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2]
C0184661
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Similar models

Eligibility Hemodialysis NCT00566670

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Adult | Age | Chronic haemodialysis
Item
the study will be comprised of adult (≥18 years) chronic hemodialysis patients.
boolean
C0001675 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
C1740835 (UMLS CUI [3])
Altered appetite Associated with Initiation Dialysis | Renal function Recovering from Kidney Failure | Patients Dialysis
Item
appetite often change with initiation of dialysis and kidney function recover sometimes from acute renal failure; hence only patients on dialysis at least for three months will be included.
boolean
C0426587 (UMLS CUI [1,1])
C0332281 (UMLS CUI [1,2])
C1704686 (UMLS CUI [1,3])
C0011946 (UMLS CUI [1,4])
C0232804 (UMLS CUI [2,1])
C0521108 (UMLS CUI [2,2])
C0035078 (UMLS CUI [2,3])
C0030705 (UMLS CUI [3,1])
C0011946 (UMLS CUI [3,2])
Urine volume function mL/day | Urine Collection Urea measurement urinary
Item
as urinary losses of urea could affect the estimation of protein intake from the urea kinetic modeling, we initially planned to exclude patients with urine output > 200 ml/day. however, this might exclude many potential participants. therefore, we plan to include those participants with upo > 200 ml/day but willing to collect 44-hr urine collection between dialysis treatments for measurement of urinary urea.
boolean
C0232856 (UMLS CUI [1,1])
C0439446 (UMLS CUI [1,2])
C0200354 (UMLS CUI [2,1])
C0523961 (UMLS CUI [2,2])
C1524119 (UMLS CUI [2,3])
Item Group
C0680251 (UMLS CUI)
Fluid overload persistent | Pedal edema Severe | Hydration status Affecting Estimation Muscle mass
Item
patients with persistent volume overload (substantial pedal edema) despite attempts at achieving dry weight will be excluded as hydration status might affect estimation of muscle mass. -
boolean
C0546817 (UMLS CUI [1,1])
C0205322 (UMLS CUI [1,2])
C0574002 (UMLS CUI [2,1])
C0205082 (UMLS CUI [2,2])
C1321013 (UMLS CUI [3,1])
C0392760 (UMLS CUI [3,2])
C0750572 (UMLS CUI [3,3])
C0240417 (UMLS CUI [3,4])
Unable to walk | Wheelchair bound | Reduced muscle mass Mid thigh Due to Disuse | Protein intake Good
Item
patients with inability to walk or those who use wheel-chair might have reduced mid-thigh muscle mass despite good protein intake because of disuse, and hence these patients will be excluded.
boolean
C0560046 (UMLS CUI [1])
C0558195 (UMLS CUI [2])
C1849578 (UMLS CUI [3,1])
C1288637 (UMLS CUI [3,2])
C0678226 (UMLS CUI [3,3])
C4062565 (UMLS CUI [3,4])
C0489617 (UMLS CUI [4,1])
C0205170 (UMLS CUI [4,2])
Artificial cardiac pacemaker | Cochlear Implants | Augmentation mammoplasty | Hip Implant Interferes with Mid thigh Muscle mass Measurement | Lumbar spine Hardware Interferes with Visceral Fat Measurement
Item
persons with pacemakers and cochlear implants are excluded because of the magnetic field of mri. certain types of materials used in breast augmentation could be affected by the strong magnetic field and hence breast augmentation is an exclusion criteria. artificial hips could interfere with mid-thigh muscle mass measurements whereas lumbar spine hardware could interfere with visceral fat measurements and hence, individuals with these will be excluded.-
boolean
C0030163 (UMLS CUI [1])
C0009199 (UMLS CUI [2])
C0191925 (UMLS CUI [3])
C0019560 (UMLS CUI [4,1])
C0521102 (UMLS CUI [4,2])
C1288637 (UMLS CUI [4,3])
C0240417 (UMLS CUI [4,4])
C0242485 (UMLS CUI [4,5])
C3887615 (UMLS CUI [5,1])
C0336577 (UMLS CUI [5,2])
C0521102 (UMLS CUI [5,3])
C1563740 (UMLS CUI [5,4])
C0242485 (UMLS CUI [5,5])
Body Weight Pounds | Atrial Fibrillation Interferes with Pulse Wave Velocity Measurement
Item
persons > 300 lbs will be excluded because of the weight limit of the mri table. atrial fibrillation could interfere with measurement of pwv.
boolean
C0005910 (UMLS CUI [1,1])
C0439219 (UMLS CUI [1,2])
C0004238 (UMLS CUI [2,1])
C0521102 (UMLS CUI [2,2])
C3494431 (UMLS CUI [2,3])
C0242485 (UMLS CUI [2,4])
Protocol Compliance Unlikely | Protocol Compliance Unable
Item
patients who are unlikely or unable (in the opinion of the nephrologists, nurses or dieticians taking care of the patient) to comply with research protocol will be excluded.
boolean
C0525058 (UMLS CUI [1,1])
C0750558 (UMLS CUI [1,2])
C0525058 (UMLS CUI [2,1])
C1299582 (UMLS CUI [2,2])
Heart failure Symptomatic | Malignant Neoplasms | Exception Squamous cell carcinoma of skin | Exception Basal cell carcinoma | Acquired Immunodeficiency Syndrome | Chronic lung disease Requirement Oxygen Therapy Care | Liver Cirrhosis
Item
patients with symptomatic heart failure, current active malignancy (excluding squamous and basal cell skin cancers), active aids, chronic lung disease requiring supplemental oxygen therapy and cirrhosis will be excluded.
boolean
C0018801 (UMLS CUI [1,1])
C0231220 (UMLS CUI [1,2])
C0006826 (UMLS CUI [2])
C1705847 (UMLS CUI [3,1])
C0553723 (UMLS CUI [3,2])
C1705847 (UMLS CUI [4,1])
C0007117 (UMLS CUI [4,2])
C0001175 (UMLS CUI [5])
C0746102 (UMLS CUI [6,1])
C1514873 (UMLS CUI [6,2])
C0184633 (UMLS CUI [6,3])
C0023890 (UMLS CUI [7])
Study Subject Participation Status | Interventional procedure
Item
patients enrolled in interventional trials will be excluded.
boolean
C2348568 (UMLS CUI [1])
C0184661 (UMLS CUI [2])
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