Global rEgistry on decongestioN Therapy using Less invasivE UltraFiltratio

• Conditions: I50.14

• Registration Number: DRKS00009836
• Lead Sponsor: Fresenius Medical Care Deutschland GmbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-12-30
• Study Completion: 2019-03-04
• Results First Posted: 2021-07-08
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 104

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

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.

Study & Design

• Study Type: observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Symptom status and rehospitalisation due to exacerbation of heart failure/volume overload of other origin within 12 months<br>

Secondary Outcome Measures

Name	Time	Method
other endpoints include safety, feasibility and performance parameters of minimal-invasive ultrafiltration