ID

35313

Beschreibung

Opioids in Chronic Kidney Disease Patients Undergoing Hemodialysis; ODM derived from: https://clinicaltrials.gov/show/NCT02452437

Link

https://clinicaltrials.gov/show/NCT02452437

Stichworte

Versionen (1)
  1. 27.02.19 27.02.19 -
Rechteinhaber

See clinicaltrials.gov

Hochgeladen am

27. Februar 2019

DOI

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Creative Commons BY 4.0
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Eligibility Chronic Kidney Disease NCT02452437

Englisch

Eligibility Chronic Kidney Disease NCT02452437

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
healthy, non-smoking, opioid intolerant caucasian men and women controls.
Beschreibung

Control Group | Caucasians Healthy | Non-smoker | Intolerance to Opioids

Datentyp

boolean

Alias
UMLS CUI [1]
C0009932
UMLS CUI [2,1]
C0043157
UMLS CUI [2,2]
C3898900
UMLS CUI [3]
C0337672
UMLS CUI [4,1]
C1744706
UMLS CUI [4,2]
C0242402
hemodialysis patients age 44 ± 10 (mean ± sd) years and normal controls 36 ± 9 years.
Beschreibung

Hemodialysis Patients | Age | Control Group

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0019004
UMLS CUI [1,2]
C0030705
UMLS CUI [2]
C0001779
UMLS CUI [3]
C0009932
no statistically significant difference in weight between hemodialysis and control patients.
Beschreibung

Body Weight | Hemodialysis Patients | Control Group

Datentyp

boolean

Alias
UMLS CUI [1]
C0005910
UMLS CUI [2,1]
C0019004
UMLS CUI [2,2]
C0030705
UMLS CUI [3]
C0009932
mean serum creatinine concentrations of 7.29 ± 1.48 mg/dl in hemodialysis patients and 0.81 ± 0.12 mg/dl in controls (normal 0.7 to 1.3 mg/dl for men and 0.6 to 1.1 mg/dl for women)
Beschreibung

Serum creatinine measurement mean | Hemodialysis Patients | Control Group | Gender

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0201976
UMLS CUI [1,2]
C0444504
UMLS CUI [2,1]
C0019004
UMLS CUI [2,2]
C0030705
UMLS CUI [3]
C0009932
UMLS CUI [4]
C0079399
mean urine output of 1.83 ± 0.47 ml/hr (44 ± 11 ml/24 hr) in hemodialysis patients and 62.32 ± 16.01 ml/hr (1496 ± 384 ml/24 hr) in controls.
Beschreibung

Urine output mean | Hemodialysis Patients | Control Group

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0232856
UMLS CUI [1,2]
C0444504
UMLS CUI [2,1]
C0019004
UMLS CUI [2,2]
C0030705
UMLS CUI [3]
C0009932
patients in both groups with normal liver function. serum prothrombin time (pt/inr), aptt, albumin, bilirubin (direct and indirect), liver transaminases, gamma-glutamyl transferase and alkaline phosphatase normal.
Beschreibung

Liver function | Serum prothrombin time | PT-INR | aPTT | Albumin measurement | Direct Bilirubin measurement | Indirect Bilirubin Measurement | Liver Transaminases | Gamma glutamyl transferase measurement | Alkaline phosphatase measurement

Datentyp

boolean

Alias
UMLS CUI [1]
C0232741
UMLS CUI [2]
C0200482
UMLS CUI [3]
C1821762
UMLS CUI [4]
C0030605
UMLS CUI [5]
C0201838
UMLS CUI [6]
C0201916
UMLS CUI [7]
C1881193
UMLS CUI [8,1]
C0023884
UMLS CUI [8,2]
C0002594
UMLS CUI [9]
C0202035
UMLS CUI [10]
C0201850
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
in both groups, a clinically significant electrocardiogram (ecg) abnormality.
Beschreibung

Electrocardiogram abnormal

Datentyp

boolean

Alias
UMLS CUI [1]
C0522055
an uncontrolled clinically significant cardiovascular condition other than end-stage kidney disease.
Beschreibung

Cardiovascular Disease Uncontrolled | Exception Chronic Kidney Failure

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0007222
UMLS CUI [1,2]
C0205318
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0022661
elevated transaminases, alkaline phosphatase, bilirubin, low phosphodiesterase, elevated ammonia levels, low glucose, elevated lactate, elevated creatinine, and hypoxia (hepatorenal syndrome)
Beschreibung

Transaminases increased | Alkaline phosphatase raised | SERUM TOTAL BILIRUBIN ELEVATED | Phosphoric diester hydrolase low | Elevated ammonia | Glucose low | Elevated lactate level | Creatinine increased | Hypoxia | Hepatorenal Syndrome

Datentyp

boolean

Alias
UMLS CUI [1]
C0438717
UMLS CUI [2]
C0151849
UMLS CUI [3]
C0595866
UMLS CUI [4,1]
C0031640
UMLS CUI [4,2]
C0205251
UMLS CUI [5]
C2675918
UMLS CUI [6]
C0860801
UMLS CUI [7]
C4054756
UMLS CUI [8]
C0151578
UMLS CUI [9]
C0242184
UMLS CUI [10]
C0019212
serum positive for hiv, hepatitis bsag, or hepatitis c
Beschreibung

HIV Seropositivity | Hepatitis B Surface Antigens Seropositive | Hepatitis C Seropositive

Datentyp

boolean

Alias
UMLS CUI [1]
C0019699
UMLS CUI [2,1]
C0019168
UMLS CUI [2,2]
C0521143
UMLS CUI [3,1]
C0019196
UMLS CUI [3,2]
C0521143
a history of drug or alcohol abuse within the past 24 months
Beschreibung

Substance Use Disorders

Datentyp

boolean

Alias
UMLS CUI [1]
C0038586
currently participating (or participated within the previous 30 days in an investigational therapeutic or device study
Beschreibung

Study Subject Participation Status | Investigational New Drugs | Investigational Medical Device

Datentyp

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2]
C0013230
UMLS CUI [3]
C2346570
female who is pregnant, nursing, or of child-bearing potential not practicing effective contraceptive methods.
Beschreibung

Pregnancy | Breast Feeding | Childbearing Potential Contraceptive methods Absent

Datentyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3,1]
C3831118
UMLS CUI [3,2]
C0700589
UMLS CUI [3,3]
C0332197
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Ähnliche Modelle

Eligibility Chronic Kidney Disease NCT02452437

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Control Group | Caucasians Healthy | Non-smoker | Intolerance to Opioids
Item
healthy, non-smoking, opioid intolerant caucasian men and women controls.
boolean
C0009932 (UMLS CUI [1])
C0043157 (UMLS CUI [2,1])
C3898900 (UMLS CUI [2,2])
C0337672 (UMLS CUI [3])
C1744706 (UMLS CUI [4,1])
C0242402 (UMLS CUI [4,2])
Hemodialysis Patients | Age | Control Group
Item
hemodialysis patients age 44 ± 10 (mean ± sd) years and normal controls 36 ± 9 years.
boolean
C0019004 (UMLS CUI [1,1])
C0030705 (UMLS CUI [1,2])
C0001779 (UMLS CUI [2])
C0009932 (UMLS CUI [3])
Body Weight | Hemodialysis Patients | Control Group
Item
no statistically significant difference in weight between hemodialysis and control patients.
boolean
C0005910 (UMLS CUI [1])
C0019004 (UMLS CUI [2,1])
C0030705 (UMLS CUI [2,2])
C0009932 (UMLS CUI [3])
Serum creatinine measurement mean | Hemodialysis Patients | Control Group | Gender
Item
mean serum creatinine concentrations of 7.29 ± 1.48 mg/dl in hemodialysis patients and 0.81 ± 0.12 mg/dl in controls (normal 0.7 to 1.3 mg/dl for men and 0.6 to 1.1 mg/dl for women)
boolean
C0201976 (UMLS CUI [1,1])
C0444504 (UMLS CUI [1,2])
C0019004 (UMLS CUI [2,1])
C0030705 (UMLS CUI [2,2])
C0009932 (UMLS CUI [3])
C0079399 (UMLS CUI [4])
Urine output mean | Hemodialysis Patients | Control Group
Item
mean urine output of 1.83 ± 0.47 ml/hr (44 ± 11 ml/24 hr) in hemodialysis patients and 62.32 ± 16.01 ml/hr (1496 ± 384 ml/24 hr) in controls.
boolean
C0232856 (UMLS CUI [1,1])
C0444504 (UMLS CUI [1,2])
C0019004 (UMLS CUI [2,1])
C0030705 (UMLS CUI [2,2])
C0009932 (UMLS CUI [3])
Liver function | Serum prothrombin time | PT-INR | aPTT | Albumin measurement | Direct Bilirubin measurement | Indirect Bilirubin Measurement | Liver Transaminases | Gamma glutamyl transferase measurement | Alkaline phosphatase measurement
Item
patients in both groups with normal liver function. serum prothrombin time (pt/inr), aptt, albumin, bilirubin (direct and indirect), liver transaminases, gamma-glutamyl transferase and alkaline phosphatase normal.
boolean
C0232741 (UMLS CUI [1])
C0200482 (UMLS CUI [2])
C1821762 (UMLS CUI [3])
C0030605 (UMLS CUI [4])
C0201838 (UMLS CUI [5])
C0201916 (UMLS CUI [6])
C1881193 (UMLS CUI [7])
C0023884 (UMLS CUI [8,1])
C0002594 (UMLS CUI [8,2])
C0202035 (UMLS CUI [9])
C0201850 (UMLS CUI [10])
Item Group
C0680251 (UMLS CUI)
Electrocardiogram abnormal
Item
in both groups, a clinically significant electrocardiogram (ecg) abnormality.
boolean
C0522055 (UMLS CUI [1])
Cardiovascular Disease Uncontrolled | Exception Chronic Kidney Failure
Item
an uncontrolled clinically significant cardiovascular condition other than end-stage kidney disease.
boolean
C0007222 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
C1705847 (UMLS CUI [2,1])
C0022661 (UMLS CUI [2,2])
Transaminases increased | Alkaline phosphatase raised | SERUM TOTAL BILIRUBIN ELEVATED | Phosphoric diester hydrolase low | Elevated ammonia | Glucose low | Elevated lactate level | Creatinine increased | Hypoxia | Hepatorenal Syndrome
Item
elevated transaminases, alkaline phosphatase, bilirubin, low phosphodiesterase, elevated ammonia levels, low glucose, elevated lactate, elevated creatinine, and hypoxia (hepatorenal syndrome)
boolean
C0438717 (UMLS CUI [1])
C0151849 (UMLS CUI [2])
C0595866 (UMLS CUI [3])
C0031640 (UMLS CUI [4,1])
C0205251 (UMLS CUI [4,2])
C2675918 (UMLS CUI [5])
C0860801 (UMLS CUI [6])
C4054756 (UMLS CUI [7])
C0151578 (UMLS CUI [8])
C0242184 (UMLS CUI [9])
C0019212 (UMLS CUI [10])
HIV Seropositivity | Hepatitis B Surface Antigens Seropositive | Hepatitis C Seropositive
Item
serum positive for hiv, hepatitis bsag, or hepatitis c
boolean
C0019699 (UMLS CUI [1])
C0019168 (UMLS CUI [2,1])
C0521143 (UMLS CUI [2,2])
C0019196 (UMLS CUI [3,1])
C0521143 (UMLS CUI [3,2])
Substance Use Disorders
Item
a history of drug or alcohol abuse within the past 24 months
boolean
C0038586 (UMLS CUI [1])
Study Subject Participation Status | Investigational New Drugs | Investigational Medical Device
Item
currently participating (or participated within the previous 30 days in an investigational therapeutic or device study
boolean
C2348568 (UMLS CUI [1])
C0013230 (UMLS CUI [2])
C2346570 (UMLS CUI [3])
Pregnancy | Breast Feeding | Childbearing Potential Contraceptive methods Absent
Item
female who is pregnant, nursing, or of child-bearing potential not practicing effective contraceptive methods.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C3831118 (UMLS CUI [3,1])
C0700589 (UMLS CUI [3,2])
C0332197 (UMLS CUI [3,3])
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