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Completed

NCT Number: NCT04073771

A Multiple Centre, Cohort Study of New 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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Zhongda Hospital, Southeast University, Nanjing, Jiangsu, China

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About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Continuous renal replacement therapy with oXiris

Device

Continuous renal replacement therapy with oXiris in patient with septic shock

Primary outcomes

  1. 28-day mortality

    Time frame: 28 days

    28-day mortality

  2. 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)

Secondary outcomes

  1. 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

  2. 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

  3. 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

  4. Vasopressor-free days

    Time frame: Day 28

    Vasopressor-free days to day 28

  5. 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

  6. ICU mortality

    Time frame: through study completion, an average of 1 month

    All cause mortality in ICU

  7. mechanical ventilation free days

    Time frame: Day 28

    Total length of mechanical ventilation free days up to to day 28

  8. Total length of Continuous Renal Replacement Therapy

    Time frame: Day 28

    Total length of Continuous Renal Replacement Therapy to day 28

Sponsors and collaborators

Lead sponsor

Southeast University, China

Other

Collaborators

  • Baxter Healthcare Corporation

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Aug 29, 2019
Registry last updated
Dec 2, 2022

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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