I50.14
Conditions
Interventions
Group 1: Assessment of therapy data in a prospective registry on peripheral, minimal invasive ultrafiltration in patients with acute volume overload, preferably in association with cardiac decompensat
Sponsors
Fresenius Medical Care Deutschland GmbH
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Age over/equal 18 years, 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. more than/equal 80 mg furosemide / 24 h or over 1375 mL urine output/40 mg furosemide per 24 h or equivalent dose of other loop diuretics [established clinically or from the medical history]), New York Association Functional Class (NYHA) III-IV at inclusion, Systolic or diastolic cardiac dysfunction (HF-REF or HF-PEF), Adequate venous access (preferably peripheral arm vein) allowing a flow rate more than/equal 60 mL / min, Written consent to the use of data in the registry (where necessary, by a legal guardian).
Exclusion criteria
Exclusion criteria: Contraindication to anticoagulation (e.g. known heparin-induced thrombocytopenia, severe bleeding), Terminal renal failure (stage V, GFR kleiner 15 mL); Cardiogenic shock, e.g. in association with acute coronary syndrome (ACS); Other diseases or factors that, in the study doctor’s opinion, constitute a potential contraindication to ultrafiltration; 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Symptom status and rehospitalisation due to exacerbation of heart failure/volume overload of other origin within 12 months | — |
Secondary
| Measure | Time frame |
|---|---|
| other endpoints include safety, feasibility and performance parameters of minimal-invasive ultrafiltration | — |
Countries
Germany, Sweden, Switzerland
Contacts
Public ContactHenning T. Baberg
Helios Klinikum Berlin BuchKlinik und Poliklinik für Kardiologie und Nephrologie
Outcome results
None listed