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Global rEgistry on decongestioN Therapy Using Less invasivE UltraFiltration

NCT02769351 · Status: TERMINATED · Type: OBSERVATIONAL · Enrollment: 104

Last updated 2021-08-05

Study results available
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Summary

In patients with advanced volume overload, minimally invasive ultrafiltration treatment in the acute phase can have a positive effect on clinical outcome. The aim is to collect treatment data in the context of a prospective registry of the safety and performance of minimally invasive ultrafiltration. The data will be recorded via an electronic case report form (eCRF); the eCRF runs on a server located in Germany and complies with current data protection regulations. It is intended to include about 300-500 patients with advanced volume overload at a minimum of 10 sites. In addition, data on a disease management programme (in-body measurement and home monitoring) will be recorded in up to 40 of these patients. The treatment data from each patient will be recorded over 12 months. An interim analysis will be performed after 150 patients have been observed for 6 months. The knowledge about ultrafiltration in volume overload obtained from the registry, in some cases in combination with a disease management programme, is intended to improve the body of evidence. In addition, the data will be used for hypothesis generation.

Conditions

  • Acute Heart Failure
  • Cardiac Decompensation
  • Volume Overload

Interventions

DEVICE

periph. minimal invasive ultrafiltration

ultrafiltration via a peripheral single-needle

Sponsors & Collaborators

  • Fresenius Medical Care Deutschland GmbH

    lead INDUSTRY

Principal Investigators

  • Henning T Baberg, MD · Helios Klinikum Berlin Buch, Berlin

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-12-03
Primary Completion
2019-03-04
Completion
2019-03-04

Countries

  • Germany
  • Sweden
  • Switzerland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02769351 on ClinicalTrials.gov