OXiris for Abdominal SEptic Shock (OASES Study)

Launched by RENJI HOSPITAL · Jul 10, 2024

Keywords

ClinConnect Summary

The OASES Study is a clinical trial that aims to explore the best timing for starting a treatment called oXiris in patients who are experiencing septic shock due to abdominal infections. Septic shock is a serious condition where the body's response to infection can lead to organ failure and requires special medical care. In this study, researchers will use advanced monitoring techniques to better understand how patients respond to oXiris therapy and to determine which patients may benefit the most from it.

To be eligible for this study, participants must be at least 18 years old, weigh at least 30 kg, and have a confirmed abdominal infection caused by certain types of bacteria. They should also be experiencing septic shock and require medications to maintain their blood pressure. This trial is not yet recruiting participants, but it will include both men and women who meet these criteria. If someone joins the study, they can expect careful monitoring and support as part of their treatment for septic shock. It's important to note that certain individuals, like those with highly contagious diseases or those who have had recent CPR, will not be able to participate.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Age ≥18 years;
• • 2. Weight ≥30 kg;
• • 3. Intra-abdominal infection (blood or abdominal drainage fluid culture positive for Gram-negative bacteria or suspected to be caused by a Gram-negative agent);
• • 4. 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;
• • 5. The dose of norepinephrine⩾0.4ug/kg/min;
• • 6. PCT⩾50ug/L, and/or IL-6⩾1000pg/ml;
• • 7. AKI stage II/III (Kidney Disease Improving Global Outcomes, KDIGO grade);
• • 8. Duration of septic shock ≤48 hours.
• Exclusion Criteria:
• • 1. Patients with highly contagious infectious diseases, such as tuberculosis;
• • 2. Pregnant and lying-in woman or lactation period;
• • 3. Infection of other sites (no abdominal infection like pneumonia, central nervous system infection and so on);
• • 4. CRRT cannot be performed for various reasons;
• • 5. Death is expected within 48 hours of admission to the ICU;
• • 6. Previous renal replacement therapy;
• • 7. Patients that underwent cardio-pulmonary resuscitation (CPR);
• • 8. Patients who will not sign the informed consent form.