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NCT Number: NCT05575024

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

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.

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Key information

Conditions

Acute Kidney Injury Due to Sepsis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • No monitoring of blood pressure and ECG

Treatment and study plan

oXiris membrane

Device

Perform continuous renal replacement therapy with oXiris membrane

Polysulfone membrane

Device

Perform continuous renal replacement therapy with polysulfone membrane

Primary outcomes

  1. Rate of all-cause mortality

    Time frame: 28 days

    Risk of all-cause mortality

  2. Occurrence rates of ventricular tachycardia, intradialytic hypotension

    Time frame: 28 days

    Risk of ventricular tachycardia, intradialytic hypotension

Study contacts

Contact information is provided by the study sponsor or research team.

Donghwan Yun, M.D.

CONTACT

[email protected]

82-10-9385-6727

Seung Seok Han, M.D.

CONTACT

[email protected]

82-2-2072-4785

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Registry information

Official study title

Real-time Monitoring of Hemodynamic Stability in Septic Shock Patients Undergoing Continuous Renal Replacement Therapy: Propensity Score-matched Comparison Between oXiris and Polysulfone Membranes

Acronym: HISTORIX

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Oct 12, 2022
Registry last updated
May 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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