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

Acute Kidney Injury Due to Sepsis Clinical Trial

— HISTORIX  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05575024
• Other study ID #: 2021-4067
• Status: Recruiting
• Start date: January 1, 2024
• Est. completion date: December 31, 2024

Study information

• Verified date: April 2024
• Source: Seoul National University Hospital
• Contact: Seung Seok Han, M.D.
• Phone: 82-2-2072-4785
• Email: hansway7[@]snu.ac.kr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 98
• Est. completion date: December 31, 2024
• Est. primary completion date: October 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Aged = 18 years

• Sepsis related acute kidney injury requiring continuous renal replacement therapy

Exclusion Criteria:

• No monitoring of blood pressure and ECG

Related Conditions & MeSH terms

• Acute Kidney Injury
• Acute Kidney Injury Due to Sepsis

Intervention

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

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of all-cause mortality	Risk of all-cause mortality	28 days
Primary	Occurrence rates of ventricular tachycardia, intradialytic hypotension	Risk of ventricular tachycardia, intradialytic hypotension	28 days