ID

28424

Descripción

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

Link

https://clinicaltrials.gov/show/NCT00702728

Palabras clave

Versiones (1)
  1. 12/1/18 12/1/18 -
Titular de derechos de autor

See clinicaltrials.gov

Subido en

12 de enero de 2018

DOI

Para solicitar uno, por favor iniciar sesión.

Licencia

Creative Commons BY 4.0
Comentarios del modelo :

Puede comentar sobre el modelo de datos aquí. A través de las burbujas de diálogo en los grupos de elementos y elementos, puede agregar comentarios específicos.

Volver a los comentarios del modelo
Comentarios de grupo de elementos para :

Comentarios del elemento para :

Para descargar modelos de datos, debe haber iniciado sesión. Por favor iniciar sesión o Registrate gratis.

Eligibility Contrast Induced Nephropathy NCT00702728

Inglés

Eligibility Contrast Induced Nephropathy NCT00702728

1 formularios  
Inclusion Criteria
Descripción

Inclusion Criteria

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

Pregnancy Absent | Age

Tipo de datos

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
Descripción

Catheterization Scheduled | Emergency Absent | Catheterization Use of Anticipated

Tipo de datos

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.
Descripción

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

Tipo de datos

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
Descripción

Stable status Clinical Killip Class

Tipo de datos

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.
Descripción

Renal function | eGFR MDRD

Tipo de datos

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.
Descripción

Agreement Follow-up Testing

Tipo de datos

boolean

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

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.
Descripción

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

Tipo de datos

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.
Descripción

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

Tipo de datos

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.
Descripción

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

Tipo de datos

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
Descripción

Foley catheter insertion Unable

Tipo de datos

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.
Descripción

Electrolyte imbalance compromises Hemodynamic State | Cardiac Arrhythmia compromises Hemodynamic State

Tipo de datos

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.
Descripción

Procedure Intravenous contrast given | Procedure Planned Using Contrast Media

Tipo de datos

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.
Descripción

Respiratory Insufficiency | Oxygen saturation measurement on room air

Tipo de datos

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
Descripción

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

Tipo de datos

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.
Descripción

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

Tipo de datos

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.
Descripción

Furosemide allergy

Tipo de datos

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.
Descripción

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

Tipo de datos

boolean

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

Pregnancy | Breast Feeding

Tipo de datos

boolean

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

Informed Consent Unable

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C1299582
Volver a la parte superior de la página

Similar models

Eligibility Contrast Induced Nephropathy NCT00702728

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
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])
Volver a la parte superior de la página 

Contacto

Utilice este formulario para comentarios, preguntas y sugerencias.

Los campos marcados con * son obligatorios.

Ayuda

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial