ID

28424

Beskrivning

Induced Diuresis With Matched Hydration Compared to Standard Hydration for Contrast Induced Nephropathy (CIN) Prevention; ODM derived from: https://clinicaltrials.gov/show/NCT00702728

Länk

https://clinicaltrials.gov/show/NCT00702728

Nyckelord

Versioner (1)
  1. 2018-01-12 2018-01-12 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

12 januari 2018

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Contrast Induced Nephropathy NCT00702728

Engelsk

Eligibility Contrast Induced Nephropathy NCT00702728

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. male or non-pregnant female equal or greater than the age of 18 years old.
Beskrivning

Pregnancy Absent | Age

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0032961
UMLS CUI [1,2]
C0332197
UMLS CUI [2]
C0001779
2. scheduled to undergo a non-emergent catheterization procedure with anticipated to use
Beskrivning

Catheterization Scheduled | Emergency Absent | Catheterization Use of Anticipated

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0007430
UMLS CUI [1,2]
C0205539
UMLS CUI [2,1]
C0013956
UMLS CUI [2,2]
C0332197
UMLS CUI [3,1]
C0007430
UMLS CUI [3,2]
C1524063
UMLS CUI [3,3]
C3840775
≥80 ml contrast media. additional other procedure (e.g., left ventriculography, imaging of grafts, stenting, etc.) are allowable other than those listed below as exclusion criteria #1.
Beskrivning

Contrast Media Dosage | Procedure Additional | Left ventriculography | Imaging Grafts | Stenting

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0009924
UMLS CUI [1,2]
C0178602
UMLS CUI [2,1]
C0184661
UMLS CUI [2,2]
C1524062
UMLS CUI [3]
C0412219
UMLS CUI [4,1]
C0011923
UMLS CUI [4,2]
C0332835
UMLS CUI [5]
C2348535
3. subject is clinically stable for >24hrs defined as killip class 1
Beskrivning

Stable status Clinical Killip Class

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0205360
UMLS CUI [1,2]
C0205210
UMLS CUI [1,3]
C1881332
4. baseline renal function egfr < 60ml/min, by mdrd (modification of diet in renal disease) calculator.
Beskrivning

Renal function | eGFR MDRD

Datatyp

boolean

Alias
UMLS CUI [1]
C0232804
UMLS CUI [2,1]
C3811844
UMLS CUI [2,2]
C3839656
5. patient has agreed to all follow-up testing.
Beskrivning

Agreement Follow-up Testing

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0680240
UMLS CUI [1,2]
C3274571
UMLS CUI [1,3]
C0039593
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. catheterization procedure requiring a direct renal injection of contrast or an injection into the descending aorta proximal to the renal arteries.
Beskrivning

Catheterization Requirement Renal artery injection Contrast Media | Catheterization Requirement Injection Descending aorta | Descending aorta Proximal Renal arteries

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0007430
UMLS CUI [1,2]
C1514873
UMLS CUI [1,3]
C0413362
UMLS CUI [1,4]
C0009924
UMLS CUI [2,1]
C0007430
UMLS CUI [2,2]
C1514873
UMLS CUI [2,3]
C1533685
UMLS CUI [2,4]
C0011666
UMLS CUI [3,1]
C0011666
UMLS CUI [3,2]
C0205107
UMLS CUI [3,3]
C0035065
2. requires emergent catheterization or primary percutaneous intervention.
Beskrivning

Emergency Catheterization Patient need for | Percutaneous Coronary Intervention Primary Patient need for

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0013956
UMLS CUI [1,2]
C0007430
UMLS CUI [1,3]
C0686904
UMLS CUI [2,1]
C1532338
UMLS CUI [2,2]
C0205225
UMLS CUI [2,3]
C0686904
3. subject is anuric, has been hospitalized for any change in renal function or has undergone renal replacement therapy (hemodialysis or hemofiltration) within the past month.
Beskrivning

Anuria | Hospitalization Renal alteration | Renal Replacement Therapy | Hemodialysis | Hemofiltration

Datatyp

boolean

Alias
UMLS CUI [1]
C0003460
UMLS CUI [2,1]
C0019993
UMLS CUI [2,2]
C0184571
UMLS CUI [3]
C0206074
UMLS CUI [4]
C0019004
UMLS CUI [5]
C0019014
4. known inability to place a foley catheter
Beskrivning

Foley catheter insertion Unable

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0850050
UMLS CUI [1,2]
C1299582
5. currently has a known electrolyte imbalance or clinically significant arrhythmias which compromise subject's hemodynamic state.
Beskrivning

Electrolyte imbalance compromises Hemodynamic State | Cardiac Arrhythmia compromises Hemodynamic State

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0342579
UMLS CUI [1,2]
C2945640
UMLS CUI [1,3]
C0019010
UMLS CUI [1,4]
C1442792
UMLS CUI [2,1]
C0003811
UMLS CUI [2,2]
C2945640
UMLS CUI [2,3]
C0019010
UMLS CUI [2,4]
C1442792
6. has received intravenous contrast within 10 days of procedure or has a planned procedure using contrast within 72 hours following the procedure.
Beskrivning

Procedure Intravenous contrast given | Procedure Planned Using Contrast Media

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0184661
UMLS CUI [1,2]
C4068213
UMLS CUI [2,1]
C0184661
UMLS CUI [2,2]
C1301732
UMLS CUI [2,3]
C1524063
UMLS CUI [2,4]
C0009924
7. has documented respiratory insufficiency as evidenced by an oxygen saturation of < 90% on room air assessed on day of procedure.
Beskrivning

Respiratory Insufficiency | Oxygen saturation measurement on room air

Datatyp

boolean

Alias
UMLS CUI [1]
C0035229
UMLS CUI [2,1]
C0523807
UMLS CUI [2,2]
C2709070
8. currently receiving or expected to receive mannitol or lithium therapy
Beskrivning

Mannitol Therapeutic procedure | Lithium therapy | Mannitol Therapeutic procedure Expected | Lithium therapy Expected

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0024730
UMLS CUI [1,2]
C0087111
UMLS CUI [2]
C0204592
UMLS CUI [3,1]
C0024730
UMLS CUI [3,2]
C0087111
UMLS CUI [3,3]
C1517001
UMLS CUI [4,1]
C0204592
UMLS CUI [4,2]
C1517001
9. planned addition, discontinuation or dose adjustment of the trimethoprim, cimetidine, metaclopramide and/or the use of non-steroidal anti-inflammatory drugs within 48 hours of the procedure.
Beskrivning

Trimethoprim Additional Planned | Trimethoprim Discontinuation | Trimethoprim Dose Adjustment | Cimetidine Additional Planned | Cimetidine Discontinuation | Cimetidine Dose Adjustment | Metoclopramide Additional Planned | Metoclopramide Discontinuation | Metoclopramide Dose Adjustment | Non-Steroidal Anti-Inflammatory Agents Additional Planned | Non-Steroidal Anti-Inflammatory Agents Discontinuation | Non-Steroidal Anti-Inflammatory Agents Dose Adjustment

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0041041
UMLS CUI [1,2]
C1524062
UMLS CUI [1,3]
C1301732
UMLS CUI [2,1]
C0041041
UMLS CUI [2,2]
C1444662
UMLS CUI [3,1]
C0041041
UMLS CUI [3,2]
C2826232
UMLS CUI [4,1]
C0008783
UMLS CUI [4,2]
C1524062
UMLS CUI [4,3]
C1301732
UMLS CUI [5,1]
C0008783
UMLS CUI [5,2]
C1444662
UMLS CUI [6,1]
C0008783
UMLS CUI [6,2]
C2826232
UMLS CUI [7,1]
C0025853
UMLS CUI [7,2]
C1524062
UMLS CUI [7,3]
C1301732
UMLS CUI [8,1]
C0025853
UMLS CUI [8,2]
C1444662
UMLS CUI [9,1]
C0025853
UMLS CUI [9,2]
C2826232
UMLS CUI [10,1]
C0003211
UMLS CUI [10,2]
C1524062
UMLS CUI [10,3]
C1301732
UMLS CUI [11,1]
C0003211
UMLS CUI [11,2]
C1444662
UMLS CUI [12,1]
C0003211
UMLS CUI [12,2]
C2826232
10. subject has a known hypersensitivity to furosemide.
Beskrivning

Furosemide allergy

Datatyp

boolean

Alias
UMLS CUI [1]
C0571903
11. subject is currently, plans, or has been enrolled in another clinical study involving use of an investigational drug or device within the prior 30 days.
Beskrivning

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

Datatyp

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2]
C0013230
UMLS CUI [3]
C2346570
12. if female, subject is pregnant or breastfeeding.
Beskrivning

Pregnancy | Breast Feeding

Datatyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
13. subject is unable to provide informed consent.
Beskrivning

Informed Consent Unable

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C1299582
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Similar models

Eligibility Contrast Induced Nephropathy NCT00702728

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Pregnancy Absent | Age
Item
1. male or non-pregnant female equal or greater than the age of 18 years old.
boolean
C0032961 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0001779 (UMLS CUI [2])
Catheterization Scheduled | Emergency Absent | Catheterization Use of Anticipated
Item
2. scheduled to undergo a non-emergent catheterization procedure with anticipated to use
boolean
C0007430 (UMLS CUI [1,1])
C0205539 (UMLS CUI [1,2])
C0013956 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C0007430 (UMLS CUI [3,1])
C1524063 (UMLS CUI [3,2])
C3840775 (UMLS CUI [3,3])
Contrast Media Dosage | Procedure Additional | Left ventriculography | Imaging Grafts | Stenting
Item
≥80 ml contrast media. additional other procedure (e.g., left ventriculography, imaging of grafts, stenting, etc.) are allowable other than those listed below as exclusion criteria #1.
boolean
C0009924 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0184661 (UMLS CUI [2,1])
C1524062 (UMLS CUI [2,2])
C0412219 (UMLS CUI [3])
C0011923 (UMLS CUI [4,1])
C0332835 (UMLS CUI [4,2])
C2348535 (UMLS CUI [5])
Stable status Clinical Killip Class
Item
3. subject is clinically stable for >24hrs defined as killip class 1
boolean
C0205360 (UMLS CUI [1,1])
C0205210 (UMLS CUI [1,2])
C1881332 (UMLS CUI [1,3])
Renal function | eGFR MDRD
Item
4. baseline renal function egfr < 60ml/min, by mdrd (modification of diet in renal disease) calculator.
boolean
C0232804 (UMLS CUI [1])
C3811844 (UMLS CUI [2,1])
C3839656 (UMLS CUI [2,2])
Agreement Follow-up Testing
Item
5. patient has agreed to all follow-up testing.
boolean
C0680240 (UMLS CUI [1,1])
C3274571 (UMLS CUI [1,2])
C0039593 (UMLS CUI [1,3])
Item Group
C0680251 (UMLS CUI)
Catheterization Requirement Renal artery injection Contrast Media | Catheterization Requirement Injection Descending aorta | Descending aorta Proximal Renal arteries
Item
1. catheterization procedure requiring a direct renal injection of contrast or an injection into the descending aorta proximal to the renal arteries.
boolean
C0007430 (UMLS CUI [1,1])
C1514873 (UMLS CUI [1,2])
C0413362 (UMLS CUI [1,3])
C0009924 (UMLS CUI [1,4])
C0007430 (UMLS CUI [2,1])
C1514873 (UMLS CUI [2,2])
C1533685 (UMLS CUI [2,3])
C0011666 (UMLS CUI [2,4])
C0011666 (UMLS CUI [3,1])
C0205107 (UMLS CUI [3,2])
C0035065 (UMLS CUI [3,3])
Emergency Catheterization Patient need for | Percutaneous Coronary Intervention Primary Patient need for
Item
2. requires emergent catheterization or primary percutaneous intervention.
boolean
C0013956 (UMLS CUI [1,1])
C0007430 (UMLS CUI [1,2])
C0686904 (UMLS CUI [1,3])
C1532338 (UMLS CUI [2,1])
C0205225 (UMLS CUI [2,2])
C0686904 (UMLS CUI [2,3])
Anuria | Hospitalization Renal alteration | Renal Replacement Therapy | Hemodialysis | Hemofiltration
Item
3. subject is anuric, has been hospitalized for any change in renal function or has undergone renal replacement therapy (hemodialysis or hemofiltration) within the past month.
boolean
C0003460 (UMLS CUI [1])
C0019993 (UMLS CUI [2,1])
C0184571 (UMLS CUI [2,2])
C0206074 (UMLS CUI [3])
C0019004 (UMLS CUI [4])
C0019014 (UMLS CUI [5])
Foley catheter insertion Unable
Item
4. known inability to place a foley catheter
boolean
C0850050 (UMLS CUI [1,1])
C1299582 (UMLS CUI [1,2])
Electrolyte imbalance compromises Hemodynamic State | Cardiac Arrhythmia compromises Hemodynamic State
Item
5. currently has a known electrolyte imbalance or clinically significant arrhythmias which compromise subject's hemodynamic state.
boolean
C0342579 (UMLS CUI [1,1])
C2945640 (UMLS CUI [1,2])
C0019010 (UMLS CUI [1,3])
C1442792 (UMLS CUI [1,4])
C0003811 (UMLS CUI [2,1])
C2945640 (UMLS CUI [2,2])
C0019010 (UMLS CUI [2,3])
C1442792 (UMLS CUI [2,4])
Procedure Intravenous contrast given | Procedure Planned Using Contrast Media
Item
6. has received intravenous contrast within 10 days of procedure or has a planned procedure using contrast within 72 hours following the procedure.
boolean
C0184661 (UMLS CUI [1,1])
C4068213 (UMLS CUI [1,2])
C0184661 (UMLS CUI [2,1])
C1301732 (UMLS CUI [2,2])
C1524063 (UMLS CUI [2,3])
C0009924 (UMLS CUI [2,4])
Respiratory Insufficiency | Oxygen saturation measurement on room air
Item
7. has documented respiratory insufficiency as evidenced by an oxygen saturation of < 90% on room air assessed on day of procedure.
boolean
C0035229 (UMLS CUI [1])
C0523807 (UMLS CUI [2,1])
C2709070 (UMLS CUI [2,2])
Mannitol Therapeutic procedure | Lithium therapy | Mannitol Therapeutic procedure Expected | Lithium therapy Expected
Item
8. currently receiving or expected to receive mannitol or lithium therapy
boolean
C0024730 (UMLS CUI [1,1])
C0087111 (UMLS CUI [1,2])
C0204592 (UMLS CUI [2])
C0024730 (UMLS CUI [3,1])
C0087111 (UMLS CUI [3,2])
C1517001 (UMLS CUI [3,3])
C0204592 (UMLS CUI [4,1])
C1517001 (UMLS CUI [4,2])
Trimethoprim Additional Planned | Trimethoprim Discontinuation | Trimethoprim Dose Adjustment | Cimetidine Additional Planned | Cimetidine Discontinuation | Cimetidine Dose Adjustment | Metoclopramide Additional Planned | Metoclopramide Discontinuation | Metoclopramide Dose Adjustment | Non-Steroidal Anti-Inflammatory Agents Additional Planned | Non-Steroidal Anti-Inflammatory Agents Discontinuation | Non-Steroidal Anti-Inflammatory Agents Dose Adjustment
Item
9. planned addition, discontinuation or dose adjustment of the trimethoprim, cimetidine, metaclopramide and/or the use of non-steroidal anti-inflammatory drugs within 48 hours of the procedure.
boolean
C0041041 (UMLS CUI [1,1])
C1524062 (UMLS CUI [1,2])
C1301732 (UMLS CUI [1,3])
C0041041 (UMLS CUI [2,1])
C1444662 (UMLS CUI [2,2])
C0041041 (UMLS CUI [3,1])
C2826232 (UMLS CUI [3,2])
C0008783 (UMLS CUI [4,1])
C1524062 (UMLS CUI [4,2])
C1301732 (UMLS CUI [4,3])
C0008783 (UMLS CUI [5,1])
C1444662 (UMLS CUI [5,2])
C0008783 (UMLS CUI [6,1])
C2826232 (UMLS CUI [6,2])
C0025853 (UMLS CUI [7,1])
C1524062 (UMLS CUI [7,2])
C1301732 (UMLS CUI [7,3])
C0025853 (UMLS CUI [8,1])
C1444662 (UMLS CUI [8,2])
C0025853 (UMLS CUI [9,1])
C2826232 (UMLS CUI [9,2])
C0003211 (UMLS CUI [10,1])
C1524062 (UMLS CUI [10,2])
C1301732 (UMLS CUI [10,3])
C0003211 (UMLS CUI [11,1])
C1444662 (UMLS CUI [11,2])
C0003211 (UMLS CUI [12,1])
C2826232 (UMLS CUI [12,2])
Furosemide allergy
Item
10. subject has a known hypersensitivity to furosemide.
boolean
C0571903 (UMLS CUI [1])
Study Subject Participation Status | Investigational New Drugs | Investigational Medical Device
Item
11. subject is currently, plans, or has been enrolled in another clinical study involving use of an investigational drug or device within the prior 30 days.
boolean
C2348568 (UMLS CUI [1])
C0013230 (UMLS CUI [2])
C2346570 (UMLS CUI [3])
Pregnancy | Breast Feeding
Item
12. if female, subject is pregnant or breastfeeding.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Informed Consent Unable
Item
13. subject is unable to provide informed consent.
boolean
C0021430 (UMLS CUI [1,1])
C1299582 (UMLS CUI [1,2])
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