ID

44236

Description

Clevidipine in the Treatment of Blood Pressure in Patients With Acute Heart Failure (PRONTO); ODM derived from: https://clinicaltrials.gov/show/NCT00803634

Link

https://clinicaltrials.gov/show/NCT00803634

Keywords

Versions (2)
  1. 4/30/18 4/30/18 -
  2. 9/20/21 9/20/21 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

September 20, 2021

DOI

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License

Creative Commons BY 4.0
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Eligibility Hypertension NCT00803634

English

Eligibility Hypertension NCT00803634

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
age 18 years or older
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
presentation consistent with acute heart failure and pulmonary congestion on physical examination as evidenced by rales
Description

Status Consistent with Heart failure | Status Consistent with Pulmonary congestion | Physical Examination | Rales

Data type

boolean

Alias
UMLS CUI [1,1]
C0449438
UMLS CUI [1,2]
C0332290
UMLS CUI [1,3]
C0018801
UMLS CUI [2,1]
C0449438
UMLS CUI [2,2]
C0332290
UMLS CUI [2,3]
C0242073
UMLS CUI [3]
C0031809
UMLS CUI [4]
C0034642
baseline systolic blood pressure (immediately prior to initiation of study drug) of
Description

Systolic Pressure

Data type

boolean

Alias
UMLS CUI [1]
C0871470
≥160 mm hg
Description

ID.4

Data type

boolean

dyspnea score (sitting) of at least 5 on a 10 cm visual analog scale (vas)
Description

Dyspnea Sitting position Visual Analog Scale

Data type

boolean

Alias
UMLS CUI [1,1]
C0013404
UMLS CUI [1,2]
C0277814
UMLS CUI [1,3]
C3536884
required iv antihypertensive therapy to lower blood pressure
Description

Patient need for Antihypertensive therapy Intravenous

Data type

boolean

Alias
UMLS CUI [1,1]
C0686904
UMLS CUI [1,2]
C0585941
UMLS CUI [1,3]
C1522726
written informed consent
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
administration of an agent (iv or oral) for the treatment of elevated bp within the previous 2 hours of randomization. (previous short-acting non-iv nitrates, continuous positive airway pressure (cpap), and bi-level positive airway pressure (bipap) were permitted)
Description

Antihypertensive Agents Intravenous | Antihypertensive Agents Oral | Nitrates Active short-term allowed | Continuous Positive Airway Pressure allowed | Bilevel positive airway pressure allowed

Data type

boolean

Alias
UMLS CUI [1,1]
C0003364
UMLS CUI [1,2]
C1522726
UMLS CUI [2,1]
C0003364
UMLS CUI [2,2]
C1527415
UMLS CUI [3,1]
C0028125
UMLS CUI [3,2]
C0205177
UMLS CUI [3,3]
C0443303
UMLS CUI [3,4]
C0683607
UMLS CUI [4,1]
C0199451
UMLS CUI [4,2]
C0683607
UMLS CUI [5,1]
C1956423
UMLS CUI [5,2]
C0683607
chest pain and/or electrocardiogram with st segment changes consistent with acute coronary syndrome
Description

Chest Pain Consistent with Acute Coronary Syndrome | ECG ST segment changes Consistent with Acute Coronary Syndrome

Data type

boolean

Alias
UMLS CUI [1,1]
C0008031
UMLS CUI [1,2]
C0332290
UMLS CUI [1,3]
C0948089
UMLS CUI [2,1]
C0232326
UMLS CUI [2,2]
C0332290
UMLS CUI [2,3]
C0948089
known or suspected aortic dissection
Description

Dissection of aorta | Dissection of aorta Suspected

Data type

boolean

Alias
UMLS CUI [1]
C0340643
UMLS CUI [2,1]
C0340643
UMLS CUI [2,2]
C0750491
acute myocardial infarction within the prior 14 days
Description

Myocardial Infarction

Data type

boolean

Alias
UMLS CUI [1]
C0027051
dialysis-dependant renal failure
Description

Dependence on dialysis Kidney Failure

Data type

boolean

Alias
UMLS CUI [1,1]
C0524376
UMLS CUI [1,2]
C0035078
requirement for immediate endotracheal intubation
Description

Patient need for Endotracheal Intubation Immediate

Data type

boolean

Alias
UMLS CUI [1,1]
C0686904
UMLS CUI [1,2]
C0021932
UMLS CUI [1,3]
C0205253
positive pregnancy test, known pregnancy or breast feeding female
Description

Pregnancy test positive | Pregnancy | Breast Feeding

Data type

boolean

Alias
UMLS CUI [1]
C0240802
UMLS CUI [2]
C0032961
UMLS CUI [3]
C0006147
intolerance or allergy to calcium channel blockers
Description

Intolerance to Calcium Channel Blockers | Calcium-channel blocker allergy

Data type

boolean

Alias
UMLS CUI [1,1]
C1744706
UMLS CUI [1,2]
C0006684
UMLS CUI [2]
C0570913
allergy to soybean oil or egg lecithin
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
known liver failure, cirrhosis or pancreatitis
Description

Liver Failure | Liver Cirrhosis | Pancreatitis

Data type

boolean

Alias
UMLS CUI [1]
C0085605
UMLS CUI [2]
C0023890
UMLS CUI [3]
C0030305
prior directives against advanced life support
Description

Directive Against Life support Advanced

Data type

boolean

Alias
UMLS CUI [1,1]
C3871158
UMLS CUI [1,2]
C0521124
UMLS CUI [1,3]
C0521300
UMLS CUI [1,4]
C0205179
participation in other clinical research studies involving the evaluation of other investigational drugs or devices within 30 days of enrollment
Description

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

Data type

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2,1]
C1261322
UMLS CUI [2,2]
C0013230
UMLS CUI [3,1]
C1261322
UMLS CUI [3,2]
C2346570
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Similar models

Eligibility Hypertension NCT00803634

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
age 18 years or older
boolean
C0001779 (UMLS CUI [1])
Status Consistent with Heart failure | Status Consistent with Pulmonary congestion | Physical Examination | Rales
Item
presentation consistent with acute heart failure and pulmonary congestion on physical examination as evidenced by rales
boolean
C0449438 (UMLS CUI [1,1])
C0332290 (UMLS CUI [1,2])
C0018801 (UMLS CUI [1,3])
C0449438 (UMLS CUI [2,1])
C0332290 (UMLS CUI [2,2])
C0242073 (UMLS CUI [2,3])
C0031809 (UMLS CUI [3])
C0034642 (UMLS CUI [4])
Systolic Pressure
Item
baseline systolic blood pressure (immediately prior to initiation of study drug) of
boolean
C0871470 (UMLS CUI [1])
ID.4
Item
≥160 mm hg
boolean
Dyspnea Sitting position Visual Analog Scale
Item
dyspnea score (sitting) of at least 5 on a 10 cm visual analog scale (vas)
boolean
C0013404 (UMLS CUI [1,1])
C0277814 (UMLS CUI [1,2])
C3536884 (UMLS CUI [1,3])
Patient need for Antihypertensive therapy Intravenous
Item
required iv antihypertensive therapy to lower blood pressure
boolean
C0686904 (UMLS CUI [1,1])
C0585941 (UMLS CUI [1,2])
C1522726 (UMLS CUI [1,3])
Informed Consent
Item
written informed consent
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Antihypertensive Agents Intravenous | Antihypertensive Agents Oral | Nitrates Active short-term allowed | Continuous Positive Airway Pressure allowed | Bilevel positive airway pressure allowed
Item
administration of an agent (iv or oral) for the treatment of elevated bp within the previous 2 hours of randomization. (previous short-acting non-iv nitrates, continuous positive airway pressure (cpap), and bi-level positive airway pressure (bipap) were permitted)
boolean
C0003364 (UMLS CUI [1,1])
C1522726 (UMLS CUI [1,2])
C0003364 (UMLS CUI [2,1])
C1527415 (UMLS CUI [2,2])
C0028125 (UMLS CUI [3,1])
C0205177 (UMLS CUI [3,2])
C0443303 (UMLS CUI [3,3])
C0683607 (UMLS CUI [3,4])
C0199451 (UMLS CUI [4,1])
C0683607 (UMLS CUI [4,2])
C1956423 (UMLS CUI [5,1])
C0683607 (UMLS CUI [5,2])
Chest Pain Consistent with Acute Coronary Syndrome | ECG ST segment changes Consistent with Acute Coronary Syndrome
Item
chest pain and/or electrocardiogram with st segment changes consistent with acute coronary syndrome
boolean
C0008031 (UMLS CUI [1,1])
C0332290 (UMLS CUI [1,2])
C0948089 (UMLS CUI [1,3])
C0232326 (UMLS CUI [2,1])
C0332290 (UMLS CUI [2,2])
C0948089 (UMLS CUI [2,3])
Dissection of aorta | Dissection of aorta Suspected
Item
known or suspected aortic dissection
boolean
C0340643 (UMLS CUI [1])
C0340643 (UMLS CUI [2,1])
C0750491 (UMLS CUI [2,2])
Myocardial Infarction
Item
acute myocardial infarction within the prior 14 days
boolean
C0027051 (UMLS CUI [1])
Dependence on dialysis Kidney Failure
Item
dialysis-dependant renal failure
boolean
C0524376 (UMLS CUI [1,1])
C0035078 (UMLS CUI [1,2])
Patient need for Endotracheal Intubation Immediate
Item
requirement for immediate endotracheal intubation
boolean
C0686904 (UMLS CUI [1,1])
C0021932 (UMLS CUI [1,2])
C0205253 (UMLS CUI [1,3])
Pregnancy test positive | Pregnancy | Breast Feeding
Item
positive pregnancy test, known pregnancy or breast feeding female
boolean
C0240802 (UMLS CUI [1])
C0032961 (UMLS CUI [2])
C0006147 (UMLS CUI [3])
Intolerance to Calcium Channel Blockers | Calcium-channel blocker allergy
Item
intolerance or allergy to calcium channel blockers
boolean
C1744706 (UMLS CUI [1,1])
C0006684 (UMLS CUI [1,2])
C0570913 (UMLS CUI [2])
Hypersensitivity Soybean Oil | Hypersensitivity Egg lecithin
Item
allergy to soybean oil or egg lecithin
boolean
C0020517 (UMLS CUI [1,1])
C0037732 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C0772274 (UMLS CUI [2,2])
Liver Failure | Liver Cirrhosis | Pancreatitis
Item
known liver failure, cirrhosis or pancreatitis
boolean
C0085605 (UMLS CUI [1])
C0023890 (UMLS CUI [2])
C0030305 (UMLS CUI [3])
Directive Against Life support Advanced
Item
prior directives against advanced life support
boolean
C3871158 (UMLS CUI [1,1])
C0521124 (UMLS CUI [1,2])
C0521300 (UMLS CUI [1,3])
C0205179 (UMLS CUI [1,4])
Study Subject Participation Status | Evaluation Investigational New Drugs | Evaluation Investigational Medical Device
Item
participation in other clinical research studies involving the evaluation of other investigational drugs or devices within 30 days of enrollment
boolean
C2348568 (UMLS CUI [1])
C1261322 (UMLS CUI [2,1])
C0013230 (UMLS CUI [2,2])
C1261322 (UMLS CUI [3,1])
C2346570 (UMLS CUI [3,2])
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