ID

20245

Beskrivning

Natrecor (Nesiritide) in Transplant-Eligible Management of Congestive Heart Failure-TMAC; ODM derived from: https://clinicaltrials.gov/show/NCT00338455

Länk

https://clinicaltrials.gov/show/NCT00338455

Nyckelord

Versioner (1)
  1. 2017-02-16 2017-02-16 -
Uppladdad den

16 februari 2017

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Congestive Heart Failure NCT00338455

Engelsk

Eligibility Congestive Heart Failure NCT00338455

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
meet the criteria for a united network for organ sharing (unos) status 1b heart transplant candidate, or, if outside the us, have comparable status
Beskrivning

heart transplant candidate

Datatyp

boolean

Alias
UMLS CUI [1]
C2029942
must also be a primary transplant candidate waiting to receive a single cardiac allograft
Beskrivning

Heart transplant candidate Primary | Patient waiting for Allograft heart Single

Datatyp

boolean

Alias
UMLS CUI [1,1]
C2029942
UMLS CUI [1,2]
C0205225
UMLS CUI [2,1]
C0542399
UMLS CUI [2,2]
C0564471
UMLS CUI [2,3]
C0205171
must be receiving continuous intravenous infusion of dobutamine or milrinone through a double-lumen central catheter or a double-lumen percutaneously inserted central catheter for at least 3 consecutive days before randomization
Beskrivning

Dobutamine Intravenous infusion | Milrinone Intravenous infusion | Double lumen catheter Central venous | Double lumen percutaneous placement of central venous catheter

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0012963
UMLS CUI [1,2]
C0021440
UMLS CUI [2,1]
C0128513
UMLS CUI [2,2]
C0021440
UMLS CUI [3,1]
C0441131
UMLS CUI [3,2]
C0444466
UMLS CUI [4,1]
C0441131
UMLS CUI [4,2]
C2026322
must be willing and able to participate in the study assessments and follow up procedures
Beskrivning

Protocol Compliance

Datatyp

boolean

Alias
UMLS CUI [1]
C0525058
male and female subjects of childbearing potential agree to use two highly effective methods of birth control for the duration of the study.
Beskrivning

Childbearing Potential Contraceptive methods

Datatyp

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0700589
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
not have systolic blood pressure (sbp) consistently < 80 mm hg, or have clinically significant orthostatic hypotension
Beskrivning

Systolic Pressure | Hypotension, Orthostatic

Datatyp

boolean

Alias
UMLS CUI [1]
C0871470
UMLS CUI [2]
C0020651
not weigh > 130 kg
Beskrivning

Body Weight

Datatyp

boolean

Alias
UMLS CUI [1]
C0005910
not have a ventricular assist device (vad), or anticipate the need for a vad, during the 28-day study drug treatment period
Beskrivning

Artificial Ventricle | Artificial Ventricle Patient need for

Datatyp

boolean

Alias
UMLS CUI [1]
C0085842
UMLS CUI [2,1]
C0085842
UMLS CUI [2,2]
C0686904
not have received placement of an internal cardiac defibrillator (icd) or external cardiac defibrillator (ecd) within 72 hours before randomization
Beskrivning

Implantation of internal cardiac defibrillator | External cardiac defibrillator Implantation

Datatyp

boolean

Alias
UMLS CUI [1]
C1273352
UMLS CUI [2,1]
C0180628
UMLS CUI [2,2]
C0021107
not require chronic hemodialysis or peritoneal dialysis to treat renal failure, or had acute dialysis or ultrafiltration within 7 days before randomization
Beskrivning

Chronic haemodialysis Kidney Failure | Chronic peritoneal dialysis Kidney Failure | Dialysis | Ultrafiltration

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1740835
UMLS CUI [1,2]
C0035078
UMLS CUI [2,1]
C0455150
UMLS CUI [2,2]
C0035078
UMLS CUI [3]
C0011946
UMLS CUI [4]
C0041612
not have received antibiotic treatment within 7 days before randomization-antibiotics are permissible for any prophylactic use.
Beskrivning

Antibiotic therapy | Antibiotic Prophylaxis

Datatyp

boolean

Alias
UMLS CUI [1]
C0338237
UMLS CUI [2]
C0282638
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Similar models

Eligibility Congestive Heart Failure NCT00338455

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
heart transplant candidate
Item
meet the criteria for a united network for organ sharing (unos) status 1b heart transplant candidate, or, if outside the us, have comparable status
boolean
C2029942 (UMLS CUI [1])
Heart transplant candidate Primary | Patient waiting for Allograft heart Single
Item
must also be a primary transplant candidate waiting to receive a single cardiac allograft
boolean
C2029942 (UMLS CUI [1,1])
C0205225 (UMLS CUI [1,2])
C0542399 (UMLS CUI [2,1])
C0564471 (UMLS CUI [2,2])
C0205171 (UMLS CUI [2,3])
Dobutamine Intravenous infusion | Milrinone Intravenous infusion | Double lumen catheter Central venous | Double lumen percutaneous placement of central venous catheter
Item
must be receiving continuous intravenous infusion of dobutamine or milrinone through a double-lumen central catheter or a double-lumen percutaneously inserted central catheter for at least 3 consecutive days before randomization
boolean
C0012963 (UMLS CUI [1,1])
C0021440 (UMLS CUI [1,2])
C0128513 (UMLS CUI [2,1])
C0021440 (UMLS CUI [2,2])
C0441131 (UMLS CUI [3,1])
C0444466 (UMLS CUI [3,2])
C0441131 (UMLS CUI [4,1])
C2026322 (UMLS CUI [4,2])
Protocol Compliance
Item
must be willing and able to participate in the study assessments and follow up procedures
boolean
C0525058 (UMLS CUI [1])
Childbearing Potential Contraceptive methods
Item
male and female subjects of childbearing potential agree to use two highly effective methods of birth control for the duration of the study.
boolean
C3831118 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
Item Group
C0680251 (UMLS CUI)
Systolic Pressure | Hypotension, Orthostatic
Item
not have systolic blood pressure (sbp) consistently < 80 mm hg, or have clinically significant orthostatic hypotension
boolean
C0871470 (UMLS CUI [1])
C0020651 (UMLS CUI [2])
Body Weight
Item
not weigh > 130 kg
boolean
C0005910 (UMLS CUI [1])
Artificial Ventricle | Artificial Ventricle Patient need for
Item
not have a ventricular assist device (vad), or anticipate the need for a vad, during the 28-day study drug treatment period
boolean
C0085842 (UMLS CUI [1])
C0085842 (UMLS CUI [2,1])
C0686904 (UMLS CUI [2,2])
Implantation of internal cardiac defibrillator | External cardiac defibrillator Implantation
Item
not have received placement of an internal cardiac defibrillator (icd) or external cardiac defibrillator (ecd) within 72 hours before randomization
boolean
C1273352 (UMLS CUI [1])
C0180628 (UMLS CUI [2,1])
C0021107 (UMLS CUI [2,2])
Chronic haemodialysis Kidney Failure | Chronic peritoneal dialysis Kidney Failure | Dialysis | Ultrafiltration
Item
not require chronic hemodialysis or peritoneal dialysis to treat renal failure, or had acute dialysis or ultrafiltration within 7 days before randomization
boolean
C1740835 (UMLS CUI [1,1])
C0035078 (UMLS CUI [1,2])
C0455150 (UMLS CUI [2,1])
C0035078 (UMLS CUI [2,2])
C0011946 (UMLS CUI [3])
C0041612 (UMLS CUI [4])
Antibiotic therapy | Antibiotic Prophylaxis
Item
not have received antibiotic treatment within 7 days before randomization-antibiotics are permissible for any prophylactic use.
boolean
C0338237 (UMLS CUI [1])
C0282638 (UMLS CUI [2])
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