ID

17597

Description

Clevidipine in the Perioperative Treatment of Hypertension (ECLIPSE-NTG); ODM derived from: https://clinicaltrials.gov/show/NCT00093886

Link

https://clinicaltrials.gov/show/NCT00093886

Keywords

Versions (1)
  1. 9/25/16 9/25/16 -
Uploaded on

September 25, 2016

DOI

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License

Creative Commons BY 4.0
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Eligibility Hypertension NCT00093886

English

Eligibility Hypertension NCT00093886

1 forms  
Criteria
Description

Criteria

provide written informed consent before initiation of any study related procedures.
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
be at least 18 years of age
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
be scheduled for coronary artery bypass grafting (cabg), off pump coronary artery bypass (opcab), minimally invasive direct coronary artery bypass (midcab) surgery, and/or valve replacement/repair surgery
Description

Coronary Artery Bypass Surgery | Coronary Artery Bypass, Off-Pump | Minimally invasive direct coronary artery bypass | Heart valve replacement | Repair of heart valve

Data type

boolean

Alias
UMLS CUI [1]
C0010055
UMLS CUI [2]
C1449706
UMLS CUI [3]
C1690495
UMLS CUI [4]
C0190173
UMLS CUI [5]
C0190112
prerandomization exclusion criteria:
Description

Exclusion Criteria Randomization Before

Data type

boolean

Alias
UMLS CUI [1,1]
C0680251
UMLS CUI [1,2]
C0034656
UMLS CUI [1,3]
C0332152
women of child-bearing potential (unless they have a negative pregnancy test)
Description

Childbearing Potential Pregnancy test negative

Data type

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0427780
recent cerebrovascular accident (within 3 months before randomization)
Description

Cerebrovascular accident Recent

Data type

boolean

Alias
UMLS CUI [1,1]
C0038454
UMLS CUI [1,2]
C0332185
known intolerance to calcium channel blockers
Description

intolerance to Calcium Channel Blockers

Data type

boolean

Alias
UMLS CUI [1,1]
C1744706
UMLS CUI [1,2]
C0006684
known or suspected hypersensitivity to nitroglycerin
Description

Hypersensitivity Nitroglycerin

Data type

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0017887
allergy to soybean oil or egg lecithin (components of the lipid vehicle)
Description

Hypersensitivity Soybean Oil | Hypersensitivity egg lecithin

Data type

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0037732
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C0772274
pre-existing permanent ventricular pacing
Description

Ventricular pacing Permanent Pre-existing

Data type

boolean

Alias
UMLS CUI [1,1]
C0429115
UMLS CUI [1,2]
C0205355
UMLS CUI [1,3]
C2347662
any other disease or condition, which, in the judgment of the investigator would place a patient at undue risk by being enrolled in the trial
Description

Disease Study Subject Participation Status At risk | condition Study Subject Participation Status At risk

Data type

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C2348568
UMLS CUI [1,3]
C1444641
UMLS CUI [2,1]
C0348080
UMLS CUI [2,2]
C2348568
UMLS CUI [2,3]
C1444641
participation in another therapeutic drug or therapeutic device trial within 30 days of starting study
Description

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

Data type

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2]
C0013230
UMLS CUI [3]
C2346570
postrandomization inclusion criteria:
Description

Inclusion criteria Randomization Post

Data type

boolean

Alias
UMLS CUI [1,1]
C1512693
UMLS CUI [1,2]
C0034656
UMLS CUI [1,3]
C0687676
determined to be hypertensive perioperatively as determined by the investigator
Description

Hypertensive perioperative

Data type

boolean

Alias
UMLS CUI [1,1]
C0857121
UMLS CUI [1,2]
C1518988
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Similar models

Eligibility Hypertension NCT00093886

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Informed Consent
Item
provide written informed consent before initiation of any study related procedures.
boolean
C0021430 (UMLS CUI [1])
Age
Item
be at least 18 years of age
boolean
C0001779 (UMLS CUI [1])
Coronary Artery Bypass Surgery | Coronary Artery Bypass, Off-Pump | Minimally invasive direct coronary artery bypass | Heart valve replacement | Repair of heart valve
Item
be scheduled for coronary artery bypass grafting (cabg), off pump coronary artery bypass (opcab), minimally invasive direct coronary artery bypass (midcab) surgery, and/or valve replacement/repair surgery
boolean
C0010055 (UMLS CUI [1])
C1449706 (UMLS CUI [2])
C1690495 (UMLS CUI [3])
C0190173 (UMLS CUI [4])
C0190112 (UMLS CUI [5])
Exclusion Criteria Randomization Before
Item
prerandomization exclusion criteria:
boolean
C0680251 (UMLS CUI [1,1])
C0034656 (UMLS CUI [1,2])
C0332152 (UMLS CUI [1,3])
Childbearing Potential Pregnancy test negative
Item
women of child-bearing potential (unless they have a negative pregnancy test)
boolean
C3831118 (UMLS CUI [1,1])
C0427780 (UMLS CUI [1,2])
Cerebrovascular accident Recent
Item
recent cerebrovascular accident (within 3 months before randomization)
boolean
C0038454 (UMLS CUI [1,1])
C0332185 (UMLS CUI [1,2])
intolerance to Calcium Channel Blockers
Item
known intolerance to calcium channel blockers
boolean
C1744706 (UMLS CUI [1,1])
C0006684 (UMLS CUI [1,2])
Hypersensitivity Nitroglycerin
Item
known or suspected hypersensitivity to nitroglycerin
boolean
C0020517 (UMLS CUI [1,1])
C0017887 (UMLS CUI [1,2])
Hypersensitivity Soybean Oil | Hypersensitivity egg lecithin
Item
allergy to soybean oil or egg lecithin (components of the lipid vehicle)
boolean
C0020517 (UMLS CUI [1,1])
C0037732 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C0772274 (UMLS CUI [2,2])
Ventricular pacing Permanent Pre-existing
Item
pre-existing permanent ventricular pacing
boolean
C0429115 (UMLS CUI [1,1])
C0205355 (UMLS CUI [1,2])
C2347662 (UMLS CUI [1,3])
Disease Study Subject Participation Status At risk | condition Study Subject Participation Status At risk
Item
any other disease or condition, which, in the judgment of the investigator would place a patient at undue risk by being enrolled in the trial
boolean
C0012634 (UMLS CUI [1,1])
C2348568 (UMLS CUI [1,2])
C1444641 (UMLS CUI [1,3])
C0348080 (UMLS CUI [2,1])
C2348568 (UMLS CUI [2,2])
C1444641 (UMLS CUI [2,3])
Study Subject Participation Status | Investigational New Drugs | Investigational Medical Device
Item
participation in another therapeutic drug or therapeutic device trial within 30 days of starting study
boolean
C2348568 (UMLS CUI [1])
C0013230 (UMLS CUI [2])
C2346570 (UMLS CUI [3])
Inclusion criteria Randomization Post
Item
postrandomization inclusion criteria:
boolean
C1512693 (UMLS CUI [1,1])
C0034656 (UMLS CUI [1,2])
C0687676 (UMLS CUI [1,3])
Hypertensive perioperative
Item
determined to be hypertensive perioperatively as determined by the investigator
boolean
C0857121 (UMLS CUI [1,1])
C1518988 (UMLS CUI [1,2])
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