Hemodynamic Stability in Septic Shock Patients Undergoing Continuous Renal Replacement Therapy With oXiris Membrane

NCT ID: NCT05575024

Last Updated: 2025-05-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

98 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-01-01

Study Completion Date

2026-12-31

Brief Summary

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The new adsorbing membrane for continuous renal replacement therapy (CRRT), oXiris, can reduce plasma cytokines and endotoxins in septic shock patients with severe acute kidney injury, compared with standard membranes. However, its hemodynamic stability or benefits have not been thoroughly evaluated although this is reasonable.

Detailed Description

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The new adsorbing membrane for continuous renal replacement therapy (CRRT), oXiris, can reduce plasma cytokines and endotoxins in patients with severe acute kidney injury or sepsis, compared with standard membranes. Based on this benefit, the use of oXiris may confer better outcomes than other membranes.

The patient outcomes include cardiovascular, respiratory, renal, and overall survivals, but this information of oXiris are insufficient. Although cytokine and endotoxin removal rates are great in oXiris, the beneficial effects on the hard outcomes are needed to use oXiris in real clinical practice.

The inflammatory and cardiovascular systems have intensive crosstalk, and thus if there are remission in inflammatory process, the patients can have hemodynamic stability. Regarding this, the investigators would like to compare the hemodynamic stability between oXiris and other standard membrane such as polysulfone, using our new real-time monitoring registry.

Conditions

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Acute Kidney Injury Due to Sepsis

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Septic AKI

Patients with septic acute kidney injury requiring continuous renal replacement therapy

oXiris membrane

Intervention Type DEVICE

Perform continuous renal replacement therapy with oXiris membrane

Polysulfone membrane

Intervention Type DEVICE

Perform continuous renal replacement therapy with polysulfone membrane

Interventions

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oXiris membrane

Perform continuous renal replacement therapy with oXiris membrane

Intervention Type DEVICE

Polysulfone membrane

Perform continuous renal replacement therapy with polysulfone membrane

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Aged ≥ 18 years
* Sepsis related acute kidney injury requiring continuous renal replacement therapy

Exclusion Criteria

• No monitoring of blood pressure and ECG
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Seoul National University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Seung Seok Han, MD

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Seung Seok Han, M.D.

Role: PRINCIPAL_INVESTIGATOR

Seoul National University Hospital

Locations

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Seoul National University Hospital

Seoul, , South Korea

Site Status RECRUITING

Countries

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South Korea

Central Contacts

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Seung Seok Han, M.D.

Role: CONTACT

82-2-2072-4785

Donghwan Yun, M.D.

Role: CONTACT

82-10-9385-6727

Facility Contacts

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Seung Seok Han, M.D.

Role: primary

82-2-2072-4785

Donghwan Yun, M.D.

Role: backup

82-10-9385-6727

Other Identifiers

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2021-4067

Identifier Type: -

Identifier Source: org_study_id

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