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Analysis of Continuous Kidney Replacement Therapy (CKRT) Treatments With multiFlux Hemofilters Using Regional Citrate Anticoagulation (RCA) or Systemic Heparin Anticoagulation (RCA-Flux)

2. september 2026 oppdatert av: Fresenius Medical Care Deutschland GmbH

Analysis of CKRT Treatments With multiFlux Hemofilters Using RCA or Systemic Heparin Anticoagulation

The goal of this observational study is to assess the performance of the multiFlux hemofilterwith regional or systemic anticoagulation during CKRT treatments. The multiFlux hemofilter is a single use device within the extracorporeal blood circuit during extracorporeal blood purification treatments for acute renal replacement therapies.

Studieoversikt

Detaljert beskrivelse

Patients enrolled in this clinical investigation will be treated either with citrate anticoagulation in Continuous venovenous hemodialysis (CVVHD) or Continuous venovenous hemodiafiltration (CVVHDF) in post-dilution mode (RCA-post-CVVHDF) with RCA using 4% citrate with Ci-Ca dialysate (without gas barrier)) or with heparin in any of the possible CKRT modes (pre-, post- or pre-post CVVH, CVVHD, pre-, post- or pre-post CVVHDF) for up to 10 days based on investigator´s decision (data beyond 10 days will not be collected within the study) or until withdrawal of informed consent or death.

For the study, treatment data will be documented for a maximum of 10 days.

The selection of the filter size depends on the prescription of the attending physician. The body weight limitations as shall be considered:

Mutiflux 160 ≥ 40 kg, Multiflux 130 ≥ 30 kg, Multiflux 60 ≥ 8 kg

Studietype

Observasjonsmessig

Registrering (Antatt)

62

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studer Kontakt Backup

Studiesteder

    • Bavaria
      • Munich, Bavaria, Tyskland, 81377

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Barn
  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Nei

Prøvetakingsmetode

Sannsynlighetsprøve

Studiepopulasjon

The study population consists of critically ill patients (adults and children) requiring continuous kidney replacement therapy (CKRT).

Beskrivelse

Inclusion Criteria:

General:

Patients ≥ 18 years:

  • Informed consent signed and dated by the investigator; and

    1. if patient is able to give consent: by the study patient
    2. if patients unable to give consent: by the legal representative/spouse according to § 1358 BGB or
    3. if an emergency situation is determined: by an independent consultant physician.

      Pediatric Patients < 18 years:

  • Informed consent signed and dated by legal representative and investigator/ authorized physician.
  • The minors have received the information referred to in Article 63(2) Medical Device Regulation (MDR) in a way adapted to their age and mental maturity and from investigators or members of the investigating team who are trained or experienced in working with children. If able, the minors have to sign the informed consent, too.
  • The explicit wish of a minor who is capable of forming an opinion and assessing the information referred to in Article 63(2) MDR to refuse participation in, or to withdraw from, the clinical investigation at any time, is respected by the investigator

Study specific:

  • Body weight ≥ 8kg
  • Acute Kidney Injury (AKI) with clinical indication for CKRT
  • Clinically estimated life expectancy greater than 3 days

Exclusion Criteria:

  • Any conditions which could interfere with the patient's ability to comply with the study
  • Patient or legal representative or authorized physician during emergency situation is not able to give informed consent according to European Medical Device Regulation and corresponding national regulations
  • Participation in a different interventional clinical study during the preceding 30 days
  • Previous participation in the same study
  • Uncontrolled bleeding and coagulation disorders

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

Kohorter og intervensjoner

Gruppe / Kohort
Intervensjon / Behandling
AKI patients
Patients with acute Kidney Injury (AKI) with clinical indication for CKRT
Extracorporeal blood purification with the multiFlux 160 hemofilter during continuous kidney replacement therapy with RCA systemic heparin anticoagulation for patients suffering from acute kidney injury (AKI)
Extracorporeal blood purification with the multiFlux 160 hemofilter during continuous kidney replacement therapy with RCA using 4% citrate with Ci-Ca dialysate (without gas barrier) for patients suffering from acute kidney injury (AKI)
Extracorporeal blood purification with the multiFlux 130 hemofilter during continuous kidney replacement therapy with RCA systemic heparin anticoagulation for patients suffering from acute kidney injury (AKI)
Extracorporeal blood purification with the multiFlux130 hemofilter during continuous kidney replacement therapy with RCA using 4% citrate with Ci-Ca dialysate (without gas barrier) for patients suffering from acute kidney injury (AKI)
Extracorporeal blood purification with the multiFlux 60 hemofilter during continuous kidney replacement therapy with RCA systemic heparin anticoagulation for patients suffering from acute kidney injury (AKI)
Extracorporeal blood purification with the multiFlux 60 hemofilter during continuous kidney replacement therapy with RCA using 4% citrate with Ci-Ca dialysate (without gas barrier) for patients suffering from acute kidney injury (AKI)

Hva måler studien?

Primære resultatmål

Resultatmål
Tidsramme
Rate of clearance (Creatinine reduction in blood and effluent) as therapy efficacy at specified time points
Tidsramme: From enrollment up to 10 days
From enrollment up to 10 days
Assessment of potential electrolyte imbalances or acid base disturbances during RCA treatment
Tidsramme: From enrollment up to 10 days
From enrollment up to 10 days

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Samarbeidspartnere

Etterforskere

  • Hovedetterforsker: Christina Scharf-Janßen, PD Dr. med., LMU University Hospital

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Antatt)

1. november 2026

Primær fullføring (Antatt)

1. oktober 2027

Studiet fullført (Antatt)

1. desember 2027

Datoer for studieregistrering

Først innsendt

25. juni 2026

Først innsendt som oppfylte QC-kriteriene

25. juni 2026

Først lagt ut (Faktiske)

1. juli 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

4. september 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

2. september 2026

Sist bekreftet

1. september 2026

Mer informasjon

Begreper knyttet til denne studien

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

UBESLUTTE

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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