OXiris for Abdominal SEptic Shock (OASES Study)

NCT06504316 | Not Yet Recruiting

• 1 other identifier: LY2024-082-B
• Study Type: interventional
• Target: 192
• Locations: 1 country
• Sites: 1

Brief Summary

This study innovatively utilizes multi-modal hemodynamic monitoring (Norepinephrine equivalence, NEE+Pulse indicator Continuous Cariac output, PiCCO) to investigate the optimal timing of initiation of oXiris in abdominal infection-associated septic shock patients and to investigate prognosis on sepsis phenotypes undergoing oXiris therapy.

Conditions

Septic Shock; Abdominal Sepsis; Multi Organ Failure; Blood Purification; AKI - Acute Kidney Injury

Outcome Measures

Primary Outcomes (1)

• The dose of vasopressor agents

  Decrease range of NEE after initiation of CRRT

  CRRT 0, 6, 12, 24, 48, 72 hours

Secondary Outcomes (5)

• The value of PiCCO parameters

  CRRT 0, 6, 12, 24, 36, 48, 72 hours

• The level of inflammatory markers

  CRRT 0, 12, 24, 48, 72 hours

• The severity of illness score Severity of illness score

  CRRT 0, 24, 48, 72 hours

• The time of hospital stay

  From date of randomization until the date of end of followup

• The number of subjects of survival and kidney recovery

  Day 28, 60, 90

Other Outcomes (2)

• The nmber of subjects of survival in phenotypes of septic shock

  Day 28, 60, 90

• Filter lifespan

  From time of filter initiation using until the time of filter changed or CRRT stop (if filter no changed)

Study Arms (2)

oXiris

EXPERIMENTAL

The subjects will be accepted oXiris filter at the first treatment session for 72 hours.

Device: CRRT filter

ST 150

ACTIVE COMPARATOR

The subjects will be accepted ST 150 filter at the first treatment session for 72 hours.

Device: CRRT filter

Interventions

CRRT filter DEVICE

The subjects will be accepted CRRT using a filter for 72 hours. The subjects will be continued to CRRT or not after 72 hours (the first session of treatment) according to clinical situation by clinician decision. CRRT prescription: 1 Blood purification access: Central vein indwelling double lumen catheter (diameter 11F-13.5F) can be placed in femoral vein, internal jugular vein and subclavian vein; 2.Anti-coagulation prescription: Anticoagulant is used according clinical situation by clinician decision (such as heparin, sodium citrate, and so on); 3. Modality of CRRT: CVVH: blood flow 150-200ml/min; replacement fluid flow 30-35ml/kg/h (100% post-dilution).

ST 150; oXiris

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥18 years;
• Weight ≥30 kg;
• Intra-abdominal infection (blood or abdominal drainage fluid culture positive for Gram-negative bacteria or suspected to be caused by a Gram-negative agent);
• Diagnostic septic shock (Sepsis 3.0): Sepsis was defined as "life-threatening organ dysfunction caused by a dysregulated host response to infection" with organ dysfunction defined as an increase in qSOFA ⩾2 points. Septic shock was defined as sepsis requiring vasoactive therapy to maintain mean arterial pressure (MAP) ⩾ 65 mmHg and lactate elevation to \>2 mmol/L despite adequate volume resuscitation;
• The dose of norepinephrine⩾0.4ug/kg/min;
• PCT⩾50ug/L, and/or IL-6⩾1000pg/ml;
• AKI stage II/III (Kidney Disease Improving Global Outcomes, KDIGO grade);
• Duration of septic shock ≤48 hours.

You may not qualify if:

• Patients with highly contagious infectious diseases, such as tuberculosis;
• Pregnant and lying-in woman or lactation period;
• Infection of other sites (no abdominal infection like pneumonia, central nervous system infection and so on);
• CRRT cannot be performed for various reasons;
• Death is expected within 48 hours of admission to the ICU;
• Previous renal replacement therapy;
• Patients that underwent cardio-pulmonary resuscitation (CPR);
• Patients who will not sign the informed consent form.

Sponsors & Collaborators

• RenJi Hospital: lead

Study Sites (1)

Renji Hospital, School of Medicine, Shanghai Jiaotong University

Shanghai, 200127, China

Location

Related Publications (1)

• Chen J, Zhang Z, Gao J, Liu Y, Zhu B, Gao Y, Zhuang Y, Zhu M. A multicentre, randomised controlled clinical trial evaluating the effect of the adsorptive filter oXiris on haemodynamics in abdominal septic shock patients requiring continuous renal replacement therapy (Oxiris for Abdominal SEptic Shock study). BMJ Open. 2025 Jul 8;15(7):e094792. doi: 10.1136/bmjopen-2024-094792.

  PMID: 40633959 DERIVED

MeSH Terms

Conditions

Shock, Septic; Intraabdominal Infections; Multiple Organ Failure; Acute Kidney Injury

Condition Hierarchy (Ancestors)

Sepsis; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Shock; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Central Study Contacts

mingli zhu, MD

CONTACT

86-13701903155; millionzhu525@126.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Comparison two groups: intervention group (oXiris filter) and control group (ST 150 filter)

Study Record Dates

• First Submitted: June 23, 2024
• First Posted: July 16, 2024
• Study Start: August 15, 2024
• Primary Completion (Estimated): March 31, 2027
• Study Completion (Estimated): May 31, 2027
• Last Updated: July 16, 2024

Record last verified: 2024-07

Locations

CN (1)