ID

23075

Beschreibung

Responsible Party: Fresenius Medical Care Deutschland GmbH ClinicalTrials.gov Identifier: NCT02769351 History of Changes Other Study ID Numbers: UF-HF-01-INT DRKS00009836 ( Registry Identifier: DRKS: German Clinical Trials Register ) Study First Received: March 21, 2016 Last Updated: August 15, 2016 Individual Participant Data Plan to Share IPD: No Plan Description: Overall results will be published. Individual participant data will not be made available. Global rEgistry on decongestioN Therapy Using Less invasivE UltraFiltration (GENTLE-UF) ODM derived from: https://clinicaltrials.gov/ct2/show/NCT02769351

Link

https://clinicaltrials.gov/ct2/show/NCT02769351

Stichworte

Versionen (1)
  1. 22.06.17 22.06.17 -
Hochgeladen am

22. Juni 2017

DOI

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Creative Commons BY 4.0
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Eligibility Less Invasive Ultrafiltration in Patients with Volume Overload DRKS00009836 NCT02769351 DRKS00009836

Englisch

Eligibility Less Invasive Ultrafiltration in Patients with Volume Overload NCT02769351 DRKS00009836

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI-1
C1512693
Ages Eligible for Study: 18 Years and older (Adult, Senior)
Beschreibung

Age

Datentyp

boolean

Alias
UMLS CUI [1]
C0001779
Inpatient-treated patients with acute volume overload, preferably in association with cardiac decompensation with signs of incipient diuretic resistance (lack of increase in urine output despite significant escalation of diuretic therapy; e.g. ≥80 mg furosemide / 24 h or less than 1375 mL urine output/40 mg furosemide per 24 h or equivalent dose of other loop diuretics [established clinically or from the medical history])
Beschreibung

Fluid overload

Datentyp

boolean

Alias
UMLS CUI [1]
C0546817
New York Association Functional Class (NYHA) III-IV at inclusion
Beschreibung

NYHA

Datentyp

boolean

Alias
UMLS CUI [1]
C1275491
Systolic or diastolic cardiac dysfunction (HF-REF or HF-PEF)
Beschreibung

Cardiac dysfunction

Datentyp

boolean

Alias
UMLS CUI [1]
C3277906
Adequate venous access (preferably peripheral arm vein) allowing a flow rate ≥ 60 mL / min
Beschreibung

Venous access

Datentyp

boolean

Alias
UMLS CUI [1]
C0750164
Written consent to the use of data in the registry (where necessary, by a legal guardian).
Beschreibung

Informed Consent

Datentyp

text

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI-1
C0680251
Healthy Volunteers
Beschreibung

Control Group

Datentyp

boolean

Alias
UMLS CUI [1]
C0009932
Contraindication to anticoagulation (e.g. known heparin-induced thrombocytopenia, severe bleeding)
Beschreibung

Contraindication to anticoagulation

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C0449867
Terminal renal failure (stage V, GFR <15 mL)
Beschreibung

GFR

Datentyp

text

Alias
UMLS CUI [1]
C0017654
Cardiogenic shock, e.g. in association with acute coronary syndrome (ACS)
Beschreibung

Cardiogenic shock

Datentyp

boolean

Alias
UMLS CUI [1]
C0036980
Other diseases or factors that, in the study doctor's opinion, constitute a potential contraindication to ultrafiltration
Beschreibung

Comorbidity

Datentyp

boolean

Alias
UMLS CUI [1]
C0009488
Pregnant women, women in labour, breast-feeding women or women of childbearing potential, who are without adequate contraception or are planning a family. NB: a pregnancy test is performed systematically in women of childbearing age and the patient is not included in the event of pregnancy (positive test). It is absolutely essential that women, who have a negative test and who are included in the study, have an effective contraception.
Beschreibung

Contraceptive Methods

Datentyp

boolean

Alias
UMLS CUI [1]
C0700589
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Ähnliche Modelle

Eligibility Less Invasive Ultrafiltration in Patients with Volume Overload NCT02769351 DRKS00009836

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
Inclusion Criteria
C1512693 (UMLS CUI-1)
Age
Item
Ages Eligible for Study: 18 Years and older (Adult, Senior)
boolean
C0001779 (UMLS CUI [1])
Fluid overload
Item
Inpatient-treated patients with acute volume overload, preferably in association with cardiac decompensation with signs of incipient diuretic resistance (lack of increase in urine output despite significant escalation of diuretic therapy; e.g. ≥80 mg furosemide / 24 h or less than 1375 mL urine output/40 mg furosemide per 24 h or equivalent dose of other loop diuretics [established clinically or from the medical history])
boolean
C0546817 (UMLS CUI [1])
NYHA
Item
New York Association Functional Class (NYHA) III-IV at inclusion
boolean
C1275491 (UMLS CUI [1])
Cardiac dysfunction
Item
Systolic or diastolic cardiac dysfunction (HF-REF or HF-PEF)
boolean
C3277906 (UMLS CUI [1])
Venous access
Item
Adequate venous access (preferably peripheral arm vein) allowing a flow rate ≥ 60 mL / min
boolean
C0750164 (UMLS CUI [1])
Informed Consent
Item
Written consent to the use of data in the registry (where necessary, by a legal guardian).
text
C0021430 (UMLS CUI [1])
Item Group
Exclusion Criteria
C0680251 (UMLS CUI-1)
Control Group
Item
Healthy Volunteers
boolean
C0009932 (UMLS CUI [1])
Contraindication to anticoagulation
Item
Contraindication to anticoagulation (e.g. known heparin-induced thrombocytopenia, severe bleeding)
boolean
C1301624 (UMLS CUI [1,1])
C0449867 (UMLS CUI [1,2])
GFR
Item
Terminal renal failure (stage V, GFR <15 mL)
text
C0017654 (UMLS CUI [1])
Cardiogenic shock
Item
Cardiogenic shock, e.g. in association with acute coronary syndrome (ACS)
boolean
C0036980 (UMLS CUI [1])
Comorbidity
Item
Other diseases or factors that, in the study doctor's opinion, constitute a potential contraindication to ultrafiltration
boolean
C0009488 (UMLS CUI [1])
Contraceptive Methods
Item
Pregnant women, women in labour, breast-feeding women or women of childbearing potential, who are without adequate contraception or are planning a family. NB: a pregnancy test is performed systematically in women of childbearing age and the patient is not included in the event of pregnancy (positive test). It is absolutely essential that women, who have a negative test and who are included in the study, have an effective contraception.
boolean
C0700589 (UMLS CUI [1])
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