ID

41083

Descrição

Ultrafiltration (Aquapheresis) in Patients With Leukemia and Severe Fluid Overload; ODM derived from: https://clinicaltrials.gov/show/NCT01508260

Link

https://clinicaltrials.gov/show/NCT01508260

Palavras-chave

Versões (1)
  1. 21/06/2020 21/06/2020 -
Titular dos direitos

See clinicaltrials.gov

Transferido a

21 de junho de 2020

DOI

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Licença

Creative Commons BY 4.0
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Eligibility Leukemia NCT01508260

Inglês

Eligibility Leukemia NCT01508260

1 Formulários  
  1. StudyEvent: Eligibility
    1. Eligibility Leukemia NCT01508260
Inclusion Criteria
Descrição

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. all patients must be 18 years of age or older and have a diagnosis of leukemia and be hospitalized on leukemia floor or micu
Descrição

Age | Leukemia | Hospitalization

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2]
C0023418
UMLS CUI [3]
C0019993
2. weight gain of 10 pounds or more.
Descrição

Weight Gain Pounds

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0043094
UMLS CUI [1,2]
C0439219
3. in addition, patients should have 2 or more signs and symptoms of fluid overload such as: dyspnea, orthopnea, paroxysmal nocturnal dyspnea (pnd), peripheral edema, rales, jugular venous distension (jvd), hypoxia (pulse ox < 90% on room air) and pulmonary edema by chest x-ray.
Descrição

Signs and Symptoms Quantity Fluid overload | Dyspnea | Orthopnea | Paroxysmal nocturnal dyspnea | Peripheral edema | Rales | Jugular venous engorgement | Hypoxia | Pulse Oximetry on room air | Pulmonary Edema Chest X-ray

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0037088
UMLS CUI [1,2]
C1265611
UMLS CUI [1,3]
C0546817
UMLS CUI [2]
C0013404
UMLS CUI [3]
C0085619
UMLS CUI [4]
C1956415
UMLS CUI [5]
C0085649
UMLS CUI [6]
C0034642
UMLS CUI [7]
C0425687
UMLS CUI [8]
C0242184
UMLS CUI [9,1]
C0034108
UMLS CUI [9,2]
C2709070
UMLS CUI [10,1]
C0034063
UMLS CUI [10,2]
C0039985
4. and be poorly responsive to diuretics defined as positive fluid balance or < 1% decrease in current body weight / 24 hours with use of furosemide 60 mg iv/24h.
Descrição

Poor response to Diuretics | Positive fluid balance | Weight decreased | Furosemide Intravenous

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C1320680
UMLS CUI [1,2]
C0012798
UMLS CUI [2]
C2364300
UMLS CUI [3]
C1262477
UMLS CUI [4,1]
C0016860
UMLS CUI [4,2]
C1522726
5. subjects will be eligible regardless of poor performance, organ dysfunctions, organ failures, or other criteria of decompensation and/or debilitation.
Descrição

Poor performance status | Organ dysfunction | Decompensation | Debilitation

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1831741
UMLS CUI [2]
C0349410
UMLS CUI [3]
C0231187
UMLS CUI [4]
C0742985
6. subjects will be eligible regardless of platelet counts.
Descrição

Eligibility Independent of Platelet Count

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C1548635
UMLS CUI [1,2]
C0332291
UMLS CUI [1,3]
C1287267
7. patients may be on a regular floor or in the intensive care unit.
Descrição

Intensive care unit

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0021708
8. they may be on respiratory mechanical ventilation or not.
Descrição

Mechanical ventilation | Mechanical ventilation Absent

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0199470
UMLS CUI [2,1]
C0199470
UMLS CUI [2,2]
C0332197
Exclusion Criteria
Descrição

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. indication for dialysis (as judged necessary by nephrology (hyperkalemia, acidosis).
Descrição

Indication Dialysis | Hyperkalemia | Acidosis

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C3146298
UMLS CUI [1,2]
C0011946
UMLS CUI [2]
C0020461
UMLS CUI [3]
C0001122
2. aki defined as 100% increase in baseline creatinine.
Descrição

Kidney Failure, Acute | Serum creatinine raised

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0022660
UMLS CUI [2]
C0700225
3. hypotension (sbp < 90mmhg).
Descrição

Hypotension | Systolic Pressure

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0020649
UMLS CUI [2]
C0871470
4. pregnant or breastfeeding women are excluded.
Descrição

Pregnancy | Breast Feeding

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
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Similar models

Eligibility Leukemia NCT01508260

1 Formulários
  1. StudyEvent: Eligibility
    1. Eligibility Leukemia NCT01508260
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Item Group
C1512693 (UMLS CUI)
Age | Leukemia | Hospitalization
Item
1. all patients must be 18 years of age or older and have a diagnosis of leukemia and be hospitalized on leukemia floor or micu
boolean
C0001779 (UMLS CUI [1])
C0023418 (UMLS CUI [2])
C0019993 (UMLS CUI [3])
Weight Gain Pounds
Item
2. weight gain of 10 pounds or more.
boolean
C0043094 (UMLS CUI [1,1])
C0439219 (UMLS CUI [1,2])
Signs and Symptoms Quantity Fluid overload | Dyspnea | Orthopnea | Paroxysmal nocturnal dyspnea | Peripheral edema | Rales | Jugular venous engorgement | Hypoxia | Pulse Oximetry on room air | Pulmonary Edema Chest X-ray
Item
3. in addition, patients should have 2 or more signs and symptoms of fluid overload such as: dyspnea, orthopnea, paroxysmal nocturnal dyspnea (pnd), peripheral edema, rales, jugular venous distension (jvd), hypoxia (pulse ox < 90% on room air) and pulmonary edema by chest x-ray.
boolean
C0037088 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C0546817 (UMLS CUI [1,3])
C0013404 (UMLS CUI [2])
C0085619 (UMLS CUI [3])
C1956415 (UMLS CUI [4])
C0085649 (UMLS CUI [5])
C0034642 (UMLS CUI [6])
C0425687 (UMLS CUI [7])
C0242184 (UMLS CUI [8])
C0034108 (UMLS CUI [9,1])
C2709070 (UMLS CUI [9,2])
C0034063 (UMLS CUI [10,1])
C0039985 (UMLS CUI [10,2])
Poor response to Diuretics | Positive fluid balance | Weight decreased | Furosemide Intravenous
Item
4. and be poorly responsive to diuretics defined as positive fluid balance or < 1% decrease in current body weight / 24 hours with use of furosemide 60 mg iv/24h.
boolean
C1320680 (UMLS CUI [1,1])
C0012798 (UMLS CUI [1,2])
C2364300 (UMLS CUI [2])
C1262477 (UMLS CUI [3])
C0016860 (UMLS CUI [4,1])
C1522726 (UMLS CUI [4,2])
Poor performance status | Organ dysfunction | Decompensation | Debilitation
Item
5. subjects will be eligible regardless of poor performance, organ dysfunctions, organ failures, or other criteria of decompensation and/or debilitation.
boolean
C1831741 (UMLS CUI [1])
C0349410 (UMLS CUI [2])
C0231187 (UMLS CUI [3])
C0742985 (UMLS CUI [4])
Eligibility Independent of Platelet Count
Item
6. subjects will be eligible regardless of platelet counts.
boolean
C1548635 (UMLS CUI [1,1])
C0332291 (UMLS CUI [1,2])
C1287267 (UMLS CUI [1,3])
Intensive care unit
Item
7. patients may be on a regular floor or in the intensive care unit.
boolean
C0021708 (UMLS CUI [1])
Mechanical ventilation | Mechanical ventilation Absent
Item
8. they may be on respiratory mechanical ventilation or not.
boolean
C0199470 (UMLS CUI [1])
C0199470 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
Item Group
C0680251 (UMLS CUI)
Indication Dialysis | Hyperkalemia | Acidosis
Item
1. indication for dialysis (as judged necessary by nephrology (hyperkalemia, acidosis).
boolean
C3146298 (UMLS CUI [1,1])
C0011946 (UMLS CUI [1,2])
C0020461 (UMLS CUI [2])
C0001122 (UMLS CUI [3])
Kidney Failure, Acute | Serum creatinine raised
Item
2. aki defined as 100% increase in baseline creatinine.
boolean
C0022660 (UMLS CUI [1])
C0700225 (UMLS CUI [2])
Hypotension | Systolic Pressure
Item
3. hypotension (sbp < 90mmhg).
boolean
C0020649 (UMLS CUI [1])
C0871470 (UMLS CUI [2])
Pregnancy | Breast Feeding
Item
4. pregnant or breastfeeding women are excluded.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
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