A Multiple Centre, Cohort Study of New CRRT Membranes oXiris for Patients With Septic Shock

November 29, 2022 updated by: Songqiao Liu, Southeast University, China

A Multiple Centre, Cohort Study of New Continuous Renal Replacement Therapy (CRRT) Membranes oXiris for Patients With Septic Shock

The objectives of this study are to determine whether Continuous Renal Replacement Therapy (CRRT) with oXiris in patients with septic shock would improve clinical outcomes such as the sepsis-related organ failure assessment (SOFA) , hemodynamic, mortality compared CRRT with conventional membrane.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Sepsis is the leading cause of death in ICU, resulting in multi-organ failure in critically ill patients. Patients with septic shock combined sepsis-associated Acute kidney injury (AKI)have even poorer outcome.

Endotoxin activity, inflammation and immune dysfunction, have been consider relevant to their pathogenesis of sepsis. High levels of Inflammation are associated with worse clinical outcomes. However, all studies of anti-inflammation treatment in sepsis patient are failed and anti-inflammation treatment of sepsis still remains controversial.

oXiris is a new filter with adsorptive membrane, which removes endotoxin and inflammatory mediator from plasma. But current evidence of oXiris is limited, and only some small sample studies have proved that it can improve the haemodynamics and the sepsis-related organ failure assessment(SOFA) score.

Our hypothesis was that oXiris would be associated with better clinical outcomes, such as decreased SOFA score, improved survival rate, better hemodynamic, and improved of organ function.

Study Type

Observational

Enrollment (Actual)

590

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Jiangsu
      • Nanjing, Jiangsu, China, 210009
        • Zhongda Hospital, Southeast University
    • Sichuan
      • Chengdu, Sichuan, China
        • Department of Nephrology, Sichuan University West ChinaHospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Septic shock patients due to abdominal or pneumonia( Gram-negative bacterial infection or suspected GNB infection) treated by CRRT

Description

Inclusion Criteria:

  • >18 Years
  • Treated by CRRT using oXiris or conventional membrane
  • SOFA cardiovascular Score ≥ 3
  • Septic shock due to abdominal or pneumonia( Gram-negative bacterial infection or suspected GNB infection)
  • Written informed consent

Exclusion Criteria:

  • Chronic Kidney Disease
  • Renal replacement therapy (RRT) in the last 30 days
  • Pregnancy
  • Immunosuppressive treatment or steroids (prednisone > 0.5 mg/kg/day or equivalent).
  • Autoimmune disorder.
  • Transplant receptor.
  • Inclusion in other ongoing studies within the last 30 days.
  • Coexisting illness with a high probability of death

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Cohort study
Patients with septic shock undergoing continuous renal replacement therapy
Device: Continuous renal replacement therapy with oXiris
Continuous renal replacement therapy with oXiris in patient with septic shock

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
28-day mortality
Time Frame: 28 days
28-day mortality
28 days
The Sepsis-related Organ Failure Assessment(SOFA) cardiovascular Scores at 72 hours
Time Frame: 72 hours after Continuous Renal Replacement Therapy initiation
The Sepsis-related Organ Failure Assessment(SOFA) cardiovascular Scores at 72 hours(Scores Range 0-4, higher values represent a worse outcome)
72 hours after Continuous Renal Replacement Therapy initiation

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes of Sepsis-related Organ Failure Assessment(SOFA) Score
Time Frame: 72 hours after Continuous Renal Replacement Therapy initiation
Changes from baseline to 72 hours in Sepsis-related Organ Failure Assessment(SOFA) Score
72 hours after Continuous Renal Replacement Therapy initiation
VIS-Norepinephrine dose or equivalent
Time Frame: 72 hours after Continuous Renal Replacement Therapy initiation
Norepinephrine dose or equivalent at 72 hours after Continuous Renal Replacement Therapy initiation
72 hours after Continuous Renal Replacement Therapy initiation
Change of Norepinephrine dose Over Time
Time Frame: 72 hours after Continuous Renal Replacement Therapy initiation
Difference of Norepinephrine dose at 72 hours compared with Continuous Renal Replacement Therapy initiation
72 hours after Continuous Renal Replacement Therapy initiation
Vasopressor-free days
Time Frame: Day 28
Vasopressor-free days to day 28
Day 28
Lactate concentration at 72 hours
Time Frame: 72 hours after Continuous Renal Replacement Therapy initiation
Lactate concentration level at 72 hours after Continuous Renal Replacement Therapy initiation initiation
72 hours after Continuous Renal Replacement Therapy initiation
ICU mortality
Time Frame: through study completion, an average of 1 month
All cause mortality in ICU
through study completion, an average of 1 month
mechanical ventilation free days
Time Frame: Day 28
Total length of mechanical ventilation free days up to to day 28
Day 28
Total length of Continuous Renal Replacement Therapy
Time Frame: Day 28
Total length of Continuous Renal Replacement Therapy to day 28
Day 28

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Southeast University, China

Collaborators

Baxter Healthcare Corporation

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 21, 2019

Primary Completion (Actual)

June 30, 2021

Study Completion (Actual)

October 31, 2021

Study Registration Dates

First Submitted

August 27, 2019

First Submitted That Met QC Criteria

August 27, 2019

First Posted (Actual)

August 29, 2019

Study Record Updates

Last Update Posted (Actual)

December 2, 2022

Last Update Submitted That Met QC Criteria

November 29, 2022

Last Verified

November 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2018ZDSYLL152-P01
  • 18CECACAP1004 (Other Grant/Funding Number: Zhongda Hospital, Southeast University,)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

there is a plan to make individual participant data (IPD) available to other researchers

IPD Sharing Time Frame

Starting 6 months after publication

IPD Sharing Access Criteria

The corresponding author will review requests form and provide the IPD

IPD Sharing Supporting Information Type

  • Study Protocol
  • Statistical Analysis Plan (SAP)
  • Informed Consent Form (ICF)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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