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A exploratory study for comparison of oXiris cartridge versus standard cartridge in the continuous blood purification therapy of acute kidney injury patients with septic shock caused by complicated intra-abdominal infection

A exploratory study for comparison of oXiris cartridge versus standard cartridge in the continuous blood purification therapy of acute kidney injury patients with septic shock caused by complicated intra-abdominal infection

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1900021802
Enrollment
Unknown
Registered
2019-03-10
Start date
2019-03-01
Completion date
Unknown
Last updated
2019-03-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

sepsis

Interventions

Standard group:CRRT with standard filter
oXiris group:CRRT with oXiris filter

Sponsors

The Sixth Affiliated Hospital, Sun Yat-sen University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Aged 18 years old or more; 2. Admitted ICU patients at first time; 3. Patients with complicated intra-abdominal infection. Diagnostic criteria for complicated intra-abdominal infectionmanifesting secondary or tertiary peritonitis, single or multiple intra-abdominal abscesses, or an intra-abdominal phlegmon. 4. Patients with septic shock. Diagnostic criteria for septic shocksepsis and SOFA score=2, MAP2mmol/L, and Cardiovascular SOFA score more than 2; 5. Patients with AKI. Diagnostic criteria for AKIserum creatinine more than 2 times baseline, or urine output <0.5 ml/kg/h for =12 h; 6. Informed consentwas obtained frompatient or the patient's relative or surrogate.

Exclusion criteria

Exclusion criteria: 1. A patient whose condition is irreversible or dying; 2. Willingness to cease or cancel life-support in an artificial manner (abandonment of treatment); 3. Chronic organ dysfunction syndrome (Including Chronic Renal Failure); 4. Severe thrombocytopenia (platelet count of 30×10^9/L); 5. Patients with the intracranial hemorrhage or uncontrollable hemorrhage; 6. Anaphylaxis to heparin or a history of heparin-induced thrombocytopenia; 7. Accompanied by III degree burns or scald; 8. Severe granulocytopenia (leukocyte count of 0.5×10^9/L); 9. Organ transplantation in the last year; 10. Women who are either pregnant or breast feeding; 11. HIV-positive; 12. Suspecting with active tuberculosis; 13. Participated other drugs/instrument clinical study within 3 months before this study.

Design outcomes

Primary

MeasureTime frame
vasopressor dependency index, VDI;—

Secondary

MeasureTime frame
Inotropic score;mean arterial pressure;Total fluid balance;SOFA score;28-days Deaths;Ventilation duration;Lymphocyte count;Service life of filter;—

Countries

China

Contacts

Public ContactQiuye Kou

The Sixth Affiliated Hospital, Sun Yat-sen University

kouqiuye@126.com+86 13430222060

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026