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Recruiting NCT05575024

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

Observational Acute Kidney Injury Due to Sepsis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: oXiris membrane, Polysulfone membrane.
Who it may be relevant to
Registry conditions: Acute Kidney Injury Due to Sepsis. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
South Korea
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official 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

Overview

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

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.

Interventions

  • Device oXiris membrane
    Perform continuous renal replacement therapy with oXiris membrane
  • Device Polysulfone membrane
    Perform continuous renal replacement therapy with polysulfone membrane

Primary outcome measures

  • Rate of all-cause mortality [Time frame: 28 days]
  • Occurrence rates of ventricular tachycardia, intradialytic hypotension [Time frame: 28 days]

Eligibility criteria

Inclusion criteria

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

Exclusion criteria

  • No monitoring of blood pressure and ECG

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Case-control

Study locations

South Korea · 1 center
  • Seoul National University Hospital — Seoul

Identifiers

NCT: NCT05575024 · 2021-4067

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗