NCT05575024

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
98

participants targeted

Target at P50-P75 for all trials

Timeline
8mo left

Started Jan 2024

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress78%
Jan 2024Dec 2026

First Submitted

Initial submission to the registry

October 5, 2022

Completed
7 days until next milestone

First Posted

Study publicly available on registry

October 12, 2022

Completed
1.2 years until next milestone

Study Start

First participant enrolled

January 1, 2024

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2026

Expected
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2026

Last Updated

May 15, 2025

Status Verified

May 1, 2025

Enrollment Period

2.5 years

First QC Date

October 5, 2022

Last Update Submit

May 12, 2025

Conditions

Acute Kidney Injury Due to Sepsis

Outcome Measures

Primary Outcomes (2)

  • Rate of all-cause mortality

    Risk of all-cause mortality

    28 days

  • Occurrence rates of ventricular tachycardia, intradialytic hypotension

    Risk of ventricular tachycardia, intradialytic hypotension

    28 days

Study Arms (1)

Septic AKI

Patients with septic acute kidney injury requiring continuous renal replacement therapy

Device: oXiris membraneDevice: Polysulfone membrane

Interventions

oXiris membraneDEVICE

Perform continuous renal replacement therapy with oXiris membrane

Septic AKI
Polysulfone membraneDEVICE

Perform continuous renal replacement therapy with polysulfone membrane

Septic AKI

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adult patients who have severe acute kidney injury and require continuous renal replacement therapy because of hemodynamic instability.

You may qualify if:

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

You may not qualify if:

  • No monitoring of blood pressure and ECG

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Hospital

Seoul, 03080, South Korea

RECRUITING

Study Officials

  • Seung Seok Han, M.D.

    Seoul National University Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Seung Seok Han, M.D.

CONTACT

82-2-2072-4785hansway7@snu.ac.kr

Donghwan Yun, M.D.

CONTACT

82-10-9385-6727dactylogram@snu.ac.kr

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

October 5, 2022

First Posted

October 12, 2022

Study Start

January 1, 2024

Primary Completion (Estimated)

June 30, 2026

Study Completion (Estimated)

December 31, 2026

Last Updated

May 15, 2025

Record last verified: 2025-05

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)