ID

35857

Descripción

Effect of Dialysis on the Pharmacokinetics of Telavancin in Patients With Chronic Kidney Disease Stage 5; ODM derived from: https://clinicaltrials.gov/show/NCT02392208

Link

https://clinicaltrials.gov/show/NCT02392208

Palabras clave

Versiones (2)
  1. 28/3/19 28/3/19 -
  2. 20/9/21 20/9/21 -
Titular de derechos de autor

See clinicaltrials.gov

Subido en

28 de marzo de 2019

DOI

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Licencia

Creative Commons BY 4.0
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Eligibility End-Stage Renal Disease NCT02392208

Inglés

Eligibility End-Stage Renal Disease NCT02392208

1 formularios  
Inclusion Criteria
Descripción

Inclusion Criteria

Alias
UMLS CUI
C1512693
≥ 18 years of age
Descripción

Age

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0001779
within 50 - 150 % of ideal body weight and greater than 40 kg
Descripción

Percentage Ideal Body Weight | Body Weight

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0439165
UMLS CUI [1,2]
C0421272
UMLS CUI [2]
C0005910
ckd5 receiving maintenance hemodialysis for ≥ 3 months
Descripción

Chronic Kidney Disease Stage | Maintenance hemodialysis

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1561643
UMLS CUI [1,2]
C2074731
UMLS CUI [2]
C4040576
creatinine clearance estimate < 10 ml/min
Descripción

Estimation of creatinine clearance by Cockcroft-Gault formula

Tipo de datos

boolean

Alias
UMLS CUI [1]
C2711451
not received telavancin within the past month
Descripción

Telavancin Absent

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1453642
UMLS CUI [1,2]
C0332197
no concurrent illness or evidence of infection
Descripción

Comorbidity Absent | Communicable Disease Absent

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C0332197
UMLS CUI [2,1]
C0009450
UMLS CUI [2,2]
C0332197
able to give informed consent
Descripción

Informed Consent

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Descripción

Exclusion Criteria

Alias
UMLS CUI
C0680251
pre-study hemoglobin < 9.0 g/dl
Descripción

Hemoglobin measurement

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0518015
plasma albumin < 2.5 g/dl
Descripción

Measurement of albumin in plasma

Tipo de datos

boolean

Alias
UMLS CUI [1]
C3525688
pregnancy
Descripción

Pregnancy

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0032961
breastfeeding
Descripción

Breast Feeding

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0006147
qtc interval > 470 msec on ekg obtained within the last 6 months
Descripción

Prolonged QTc interval on ECG

Tipo de datos

boolean

Alias
UMLS CUI [1]
C4015677
receiving concomitant qt prolonging agents
Descripción

Pharmaceutical Preparations Causing Prolonged QT interval

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0678227
UMLS CUI [1,3]
C0151878
receiving warfarin or low molecular weight heparin products
Descripción

Warfarin | Heparin, Low-Molecular-Weight

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0043031
UMLS CUI [2]
C0019139
known allergy to telavancin or vancomycin
Descripción

Hypersensitivity Telavancin | Vancomycin allergy

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C1453642
UMLS CUI [2]
C0571388
unstable blood pressure control
Descripción

Unstable blood pressure Control

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C4540782
UMLS CUI [1,2]
C2587213
need for routine large fluid removal during dialysis (> 4 liters)
Descripción

Patient need for Removal Fluid Large | Dialysis procedure

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0686904
UMLS CUI [1,2]
C1883720
UMLS CUI [1,3]
C0005889
UMLS CUI [1,4]
C0549177
UMLS CUI [2]
C0011946
diagnosis of liver disease with a child pugh score of c or higher
Descripción

Liver disease Child-Pugh Classification

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0023895
UMLS CUI [1,2]
C2347612
dialysis isolation requirements due to hepatitis b
Descripción

Dialysis | Need for isolation Due to Hepatitis B

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0011946
UMLS CUI [2,1]
C0260397
UMLS CUI [2,2]
C0678226
UMLS CUI [2,3]
C0019163
participating concurrently in another investigational drug study
Descripción

Study Subject Participation Status | Investigational New Drugs

Tipo de datos

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2]
C0013230
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Similar models

Eligibility End-Stage Renal Disease NCT02392208

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
≥ 18 years of age
boolean
C0001779 (UMLS CUI [1])
Percentage Ideal Body Weight | Body Weight
Item
within 50 - 150 % of ideal body weight and greater than 40 kg
boolean
C0439165 (UMLS CUI [1,1])
C0421272 (UMLS CUI [1,2])
C0005910 (UMLS CUI [2])
Chronic Kidney Disease Stage | Maintenance hemodialysis
Item
ckd5 receiving maintenance hemodialysis for ≥ 3 months
boolean
C1561643 (UMLS CUI [1,1])
C2074731 (UMLS CUI [1,2])
C4040576 (UMLS CUI [2])
Estimation of creatinine clearance by Cockcroft-Gault formula
Item
creatinine clearance estimate < 10 ml/min
boolean
C2711451 (UMLS CUI [1])
Telavancin Absent
Item
not received telavancin within the past month
boolean
C1453642 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
Comorbidity Absent | Communicable Disease Absent
Item
no concurrent illness or evidence of infection
boolean
C0009488 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0009450 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
Informed Consent
Item
able to give informed consent
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Hemoglobin measurement
Item
pre-study hemoglobin < 9.0 g/dl
boolean
C0518015 (UMLS CUI [1])
Measurement of albumin in plasma
Item
plasma albumin < 2.5 g/dl
boolean
C3525688 (UMLS CUI [1])
Pregnancy
Item
pregnancy
boolean
C0032961 (UMLS CUI [1])
Breast Feeding
Item
breastfeeding
boolean
C0006147 (UMLS CUI [1])
Prolonged QTc interval on ECG
Item
qtc interval > 470 msec on ekg obtained within the last 6 months
boolean
C4015677 (UMLS CUI [1])
Pharmaceutical Preparations Causing Prolonged QT interval
Item
receiving concomitant qt prolonging agents
boolean
C0013227 (UMLS CUI [1,1])
C0678227 (UMLS CUI [1,2])
C0151878 (UMLS CUI [1,3])
Warfarin | Heparin, Low-Molecular-Weight
Item
receiving warfarin or low molecular weight heparin products
boolean
C0043031 (UMLS CUI [1])
C0019139 (UMLS CUI [2])
Hypersensitivity Telavancin | Vancomycin allergy
Item
known allergy to telavancin or vancomycin
boolean
C0020517 (UMLS CUI [1,1])
C1453642 (UMLS CUI [1,2])
C0571388 (UMLS CUI [2])
Unstable blood pressure Control
Item
unstable blood pressure control
boolean
C4540782 (UMLS CUI [1,1])
C2587213 (UMLS CUI [1,2])
Patient need for Removal Fluid Large | Dialysis procedure
Item
need for routine large fluid removal during dialysis (> 4 liters)
boolean
C0686904 (UMLS CUI [1,1])
C1883720 (UMLS CUI [1,2])
C0005889 (UMLS CUI [1,3])
C0549177 (UMLS CUI [1,4])
C0011946 (UMLS CUI [2])
Liver disease Child-Pugh Classification
Item
diagnosis of liver disease with a child pugh score of c or higher
boolean
C0023895 (UMLS CUI [1,1])
C2347612 (UMLS CUI [1,2])
Dialysis | Need for isolation Due to Hepatitis B
Item
dialysis isolation requirements due to hepatitis b
boolean
C0011946 (UMLS CUI [1])
C0260397 (UMLS CUI [2,1])
C0678226 (UMLS CUI [2,2])
C0019163 (UMLS CUI [2,3])
Study Subject Participation Status | Investigational New Drugs
Item
participating concurrently in another investigational drug study
boolean
C2348568 (UMLS CUI [1])
C0013230 (UMLS CUI [2])
Volver a la parte superior de la página 

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