Status:
NOT_YET_RECRUITING
OXiris for Abdominal SEptic Shock (OASES Study)
Lead Sponsor:
RenJi Hospital
Conditions:
Septic Shock
Abdominal Sepsis
Eligibility:
All Genders
18+ years
Phase:
NA
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...
Detailed Description
Sepsis is a life-threatening organ dysfunction syndrome caused by dysregulated host responses to infection, which is one of the leading causes of death for critically ill patients and also a challenge...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
August 15 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 31 2027
Estimated Enrollment :
192 Patients enrolled
Trial Details
Trial ID
NCT06504316
Start Date
August 15 2024
End Date
May 31 2027
Last Update
July 16 2024
Active Locations (1)
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1
Renji Hospital, School of Medicine, Shanghai Jiaotong University
Shanghai, China, 200127