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Use of Oxiris Filter in Septic Shock Patients Requiring Renal Replacement Therapy: A Retrospective Cohort Study

28. april 2026 opdateret af: Clinica Universidad de Navarra, Universidad de Navarra

Impact of Oxiris Filter Use on Mortality and Renal Outcomes in Critically Ill Patients With Septic Shock Requiring Renal Replacement Therapy: A Retrospective Cohort Study

Sepsis and septic shock are major causes of mortality in critically ill patients and are frequently associated with acute kidney injury requiring renal replacement therapy. The Oxiris filter is a hemofilter designed to provide both renal support and adsorption of endotoxins and inflammatory mediators. This study aims to evaluate the association between the use of the Oxiris filter and clinical outcomes in critically ill patients with septic shock requiring renal replacement therapy. A retrospective cohort design will be used, including patients admitted to an intensive care unit who received renal replacement therapy. Outcomes such as mortality and renal function will be analyzed and compared between patients treated with Oxiris and those treated with other filters.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

Sepsis and septic shock are leading causes of morbidity and mortality in critically ill patients and are commonly associated with acute kidney injury requiring renal replacement therapy (RRT). Extracorporeal blood purification techniques have been proposed as an adjunctive therapy to modulate the host inflammatory response. The Oxiris filter is a modified AN69-based membrane designed to provide renal support while simultaneously adsorbing endotoxins and cytokines.

This retrospective cohort study aims to assess the impact of Oxiris filter use on clinical outcomes in patients with septic shock requiring RRT. The study will include adult patients admitted to an intensive care unit over a defined study period who required RRT due to acute kidney injury in the context of septic shock.

Patients will be categorized according to the type of hemofilter used (Oxiris versus standard filters). The primary outcome will be mortality within a defined follow-up period. Secondary outcomes will include renal recovery, duration of renal replacement therapy, and length of stay in the intensive care unit.

Statistical analyses will be performed to compare outcomes between groups and adjust for potential confounding factors. Appropriate multivariable models will be used to evaluate the association between Oxiris use and clinical outcomes.

Given the retrospective nature of the study, no interventions will be assigned, and all treatments will have been administered according to routine clinical practice.

Undersøgelsestype

Observationel

Tilmelding (Faktiske)

400

Kontakter og lokationer

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Studiesteder

  • Spanien
    • Navarre
      • Pamplona, Navarre, Spanien, 31008
        • Clinica Universidad de Navarra

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

Critically ill adult patients admitted to an intensive care unit with septic shock and acute kidney injury requiring renal replacement therapy.

Beskrivelse

Inclusion Criteria:

  • Adult patients (≥18 years old)
  • Admission to the intensive care unit
  • Diagnosis of septic shock
  • Requirement of renal replacement therapy due to acute kidney injury
  • Treatment with either Oxiris filter or standard hemofilters

Exclusion Criteria:

  • Patients under 18 years of age
  • Chronic dialysis prior to ICU admission
  • Missing key clinical data
  • Patients not meeting criteria for septic shock

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Kohorter og interventioner

Gruppe / kohorte
Intervention / Behandling
Oxiris Group
Patients with septic shock requiring renal replacement therapy treated with the Oxiris filter.
Enhed: Oxiris filter
Hemofilter used for renal replacement therapy with cytokine and endotoxin adsorption properties.
Standard Filter Group
Patients with septic shock requiring renal replacement therapy treated with standard hemofilters.
Enhed: Standard Hemofilter
Standard hemofilters used for continuous renal replacement therapy without specific adsorption properties for endotoxins or cytokines. These filters provide conventional renal support and are used according to routine clinical practice.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
28-day all-cause mortality
Tidsramme: Up to 28 days
All-cause mortality within 28 days from the initiation of renal replacement therapy.
Up to 28 days

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
ICU length of stay
Tidsramme: From ICU admission to ICU discharge, assessed up to 28 days
Length of stay in the intensive care unit measured in days.
From ICU admission to ICU discharge, assessed up to 28 days
Renal recovery
Tidsramme: Assessed at hospital discharge, up to 90 days
Recovery of kidney function defined as independence from renal replacement therapy at discharge.
Assessed at hospital discharge, up to 90 days
Duration of renal replacement therapy
Tidsramme: From initiation to discontinuation of RRT, assessed up to 28 days
Total duration of renal replacement therapy during ICU stay, measured in days.
From initiation to discontinuation of RRT, assessed up to 28 days
In-hospital mortality
Tidsramme: From hospital admission to discharge, assessed up to 90 days
All-cause mortality during hospital stay.
From hospital admission to discharge, assessed up to 90 days

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Clinica Universidad de Navarra, Universidad de Navarra

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

1. januar 2012

Primær færdiggørelse (Faktiske)

31. juli 2024

Studieafslutning (Faktiske)

31. december 2024

Datoer for studieregistrering

Først indsendt

20. april 2026

Først indsendt, der opfyldte QC-kriterier

28. april 2026

Først opslået (Faktiske)

6. maj 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

6. maj 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

28. april 2026

Sidst verificeret

1. april 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • OXIRIS

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

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Ingen

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Kliniske forsøg med Septisk chok

Kliniske forsøg med Oxiris filter

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