ID

40703

Description

Comparative Investigation of Intravenously Administered Omnipaque and Isovue: Effects on Serum Creatinine Concentration in Outpatients; ODM derived from: https://clinicaltrials.gov/show/NCT00734357

Link

https://clinicaltrials.gov/show/NCT00734357

Keywords

Versions (1)
  1. 4/30/20 4/30/20 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

April 30, 2020

DOI

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License

Creative Commons BY 4.0
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Eligibility Kidney Disease NCT00734357

English

Eligibility Kidney Disease NCT00734357

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
patients 18 years of age and older
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
patients referred for a contrast-enhanced ct examination. such contrast- enhanced ct examinations include, but are not limited to, certain examinations of the head, neck, chest, abdomen, pelvis, etc.
Description

Referral for CT with Contrast | CT with Contrast Head | CT with Contrast Neck | CT with Contrast Chest | CT with Contrast Abdomen | CT with Contrast Pelvis

Data type

boolean

Alias
UMLS CUI [1,1]
C2585524
UMLS CUI [1,2]
C0742919
UMLS CUI [2,1]
C0742919
UMLS CUI [2,2]
C0018670
UMLS CUI [3,1]
C0742919
UMLS CUI [3,2]
C0027530
UMLS CUI [4,1]
C0742919
UMLS CUI [4,2]
C0817096
UMLS CUI [5,1]
C0742919
UMLS CUI [5,2]
C0000726
UMLS CUI [6,1]
C0742919
UMLS CUI [6,2]
C0030797
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
patients less than age of 18 years of age
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
pregnant patients
Description

Pregnancy

Data type

boolean

Alias
UMLS CUI [1]
C0032961
patients unable to provide written informed consent
Description

Informed Consent Unable

Data type

boolean

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C1299582
patients in whom there are contraindications to the administration of intravenous contrast material (as detailed in out department of radiology intravenous contrast material use guidelines), including renal contraindications (such as a university of michigan laboratory record of most recent serum creatinine concentration of >1.5 mg/dl or an estimated glomerular filtration rate (egfr) <60 ml/min); if no serum creatinine is available, patients will be receive contrast material based on departmental guidelines
Description

Medical contraindication Intravenous contrast | Medical contraindication renal | Creatinine measurement, serum | Estimated Glomerular Filtration Rate

Data type

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C4072741
UMLS CUI [2,1]
C1301624
UMLS CUI [2,2]
C0022646
UMLS CUI [3]
C0201976
UMLS CUI [4]
C3811844
patients who are undergoing therapy with agents purported to reduce the risk of cin (such as acetylcysteine, theophylline, or intravenous hydration)
Description

Therapy Against Contrast - Induced Nephropathy | Acetylcysteine | Theophylline | Intravenous hydration infusion

Data type

boolean

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C0521124
UMLS CUI [1,3]
C4055183
UMLS CUI [2]
C0001047
UMLS CUI [3]
C0039771
UMLS CUI [4]
C3527035
patients who are unable to provide the follow-up serum creatinine concentration measurements
Description

Serum creatinine measurement Unable

Data type

boolean

Alias
UMLS CUI [1,1]
C0201976
UMLS CUI [1,2]
C1299582
patients undergoing ct examinations that utilize a higher concentration of iodine (for example, 370 mg i/ml contrast material)
Description

CT Iodinated contrast agent Abnormal

Data type

boolean

Alias
UMLS CUI [1,1]
C0040405
UMLS CUI [1,2]
C0879373
UMLS CUI [1,3]
C0205161
patients who have experienced allergic-like reactions to contrast; including patients who receive corticosteroid/antihistamine premedication to reduce the risk of an acute allergic-like reaction
Description

Patient Allergic to Contrast Media

Data type

boolean

Alias
UMLS CUI [1]
C2347454
patients who do not receive the study criterion for dose of contrast material; and patients in whom a contrast extravasation of more than 5 ml occurs (so that it is not possible to determine how much contrast material the patient received as a direct intravenous injection)
Description

Contrast Media Dose Inadequate | Extravasation of Contrast Media Amount

Data type

boolean

Alias
UMLS CUI [1,1]
C0178602
UMLS CUI [1,2]
C0205412
UMLS CUI [1,3]
C0009924
UMLS CUI [2,1]
C0015378
UMLS CUI [2,2]
C1265611
patients participating in other investigational drug, contrast material, or device trials
Description

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

Data type

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2]
C0013230
UMLS CUI [3]
C0009924
UMLS CUI [4]
C2346570
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Similar models

Eligibility Kidney Disease NCT00734357

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
patients 18 years of age and older
boolean
C0001779 (UMLS CUI [1])
Referral for CT with Contrast | CT with Contrast Head | CT with Contrast Neck | CT with Contrast Chest | CT with Contrast Abdomen | CT with Contrast Pelvis
Item
patients referred for a contrast-enhanced ct examination. such contrast- enhanced ct examinations include, but are not limited to, certain examinations of the head, neck, chest, abdomen, pelvis, etc.
boolean
C2585524 (UMLS CUI [1,1])
C0742919 (UMLS CUI [1,2])
C0742919 (UMLS CUI [2,1])
C0018670 (UMLS CUI [2,2])
C0742919 (UMLS CUI [3,1])
C0027530 (UMLS CUI [3,2])
C0742919 (UMLS CUI [4,1])
C0817096 (UMLS CUI [4,2])
C0742919 (UMLS CUI [5,1])
C0000726 (UMLS CUI [5,2])
C0742919 (UMLS CUI [6,1])
C0030797 (UMLS CUI [6,2])
Item Group
C0680251 (UMLS CUI)
Age
Item
patients less than age of 18 years of age
boolean
C0001779 (UMLS CUI [1])
Pregnancy
Item
pregnant patients
boolean
C0032961 (UMLS CUI [1])
Informed Consent Unable
Item
patients unable to provide written informed consent
boolean
C0021430 (UMLS CUI [1,1])
C1299582 (UMLS CUI [1,2])
Medical contraindication Intravenous contrast | Medical contraindication renal | Creatinine measurement, serum | Estimated Glomerular Filtration Rate
Item
patients in whom there are contraindications to the administration of intravenous contrast material (as detailed in out department of radiology intravenous contrast material use guidelines), including renal contraindications (such as a university of michigan laboratory record of most recent serum creatinine concentration of >1.5 mg/dl or an estimated glomerular filtration rate (egfr) <60 ml/min); if no serum creatinine is available, patients will be receive contrast material based on departmental guidelines
boolean
C1301624 (UMLS CUI [1,1])
C4072741 (UMLS CUI [1,2])
C1301624 (UMLS CUI [2,1])
C0022646 (UMLS CUI [2,2])
C0201976 (UMLS CUI [3])
C3811844 (UMLS CUI [4])
Therapy Against Contrast - Induced Nephropathy | Acetylcysteine | Theophylline | Intravenous hydration infusion
Item
patients who are undergoing therapy with agents purported to reduce the risk of cin (such as acetylcysteine, theophylline, or intravenous hydration)
boolean
C0087111 (UMLS CUI [1,1])
C0521124 (UMLS CUI [1,2])
C4055183 (UMLS CUI [1,3])
C0001047 (UMLS CUI [2])
C0039771 (UMLS CUI [3])
C3527035 (UMLS CUI [4])
Serum creatinine measurement Unable
Item
patients who are unable to provide the follow-up serum creatinine concentration measurements
boolean
C0201976 (UMLS CUI [1,1])
C1299582 (UMLS CUI [1,2])
CT Iodinated contrast agent Abnormal
Item
patients undergoing ct examinations that utilize a higher concentration of iodine (for example, 370 mg i/ml contrast material)
boolean
C0040405 (UMLS CUI [1,1])
C0879373 (UMLS CUI [1,2])
C0205161 (UMLS CUI [1,3])
Patient Allergic to Contrast Media
Item
patients who have experienced allergic-like reactions to contrast; including patients who receive corticosteroid/antihistamine premedication to reduce the risk of an acute allergic-like reaction
boolean
C2347454 (UMLS CUI [1])
Contrast Media Dose Inadequate | Extravasation of Contrast Media Amount
Item
patients who do not receive the study criterion for dose of contrast material; and patients in whom a contrast extravasation of more than 5 ml occurs (so that it is not possible to determine how much contrast material the patient received as a direct intravenous injection)
boolean
C0178602 (UMLS CUI [1,1])
C0205412 (UMLS CUI [1,2])
C0009924 (UMLS CUI [1,3])
C0015378 (UMLS CUI [2,1])
C1265611 (UMLS CUI [2,2])
Study Subject Participation Status | Investigational New Drugs | Contrast Media | Investigational Medical Device
Item
patients participating in other investigational drug, contrast material, or device trials
boolean
C2348568 (UMLS CUI [1])
C0013230 (UMLS CUI [2])
C0009924 (UMLS CUI [3])
C2346570 (UMLS CUI [4])
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