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Efficacy and Safety of Polymyxin B Hemoperfusion(TORAYMYXIN) in Gram-negative Abdominal Sepsis-A prospective, multicenter, randomized controlled trial

A Trial of Efficacy and Safety of Polymyxin B Hemoperfusion(TORAYMYXIN) in Gram-negative Abdominal S

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-IOR-14005248
Enrollment
Unknown
Registered
2014-09-16
Start date
2014-01-03
Completion date
Unknown
Last updated
2017-04-18

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

Conditions

Sepsis or septic shock

Interventions

Experimental:polymyxin B hemoperfusion added to conventionalmed
Control:conventionalmedical therapy

Sponsors

Department of Nephrology, West China Hospital of Sichuan University, Chengdu, Sichuan, China
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Sepsis or septic shockdue to abdominal cavity infection: (1) After emergency abdominal surgery; (2) SOFA score=10, and Cardiovascular SOFA score more than 2; 2. Aged between 18 to 75 years; 3. Weight more than 40kg; 4. Informed consentwas obtained frompatient or the patient's relative or surrogate.

Exclusion criteria

Exclusion criteria: 1Traumatosepsis 2Patients with the intracranial hemorrhage or uncontrollablehemorrhage 3?Chronic organ dysfunction syndrome(Including Chronic Renal Failure) 4?have chosen palliative care and signed Do Not Resuscitate sheet 5?Accompanied by ? degree burns or scald 6?history of sensitivity to polymyxin B or to anticoagulant (heparin) 7?Severe granulocytopenia (leukocyte count of 0.5×109/L) 8?Severe thrombocytopenia (platelet count of 30×109/L) 9?Organ transplantation in the last year 10?Women who are either pregnant or breast feeding. 11?HIV-positive 12?Suspect case of active tuberculosis 13?Use of other investigational drugs at the time of enrolment or within 3 months before study entry 14?Unsuitable patients considered by researchers

Design outcomes

Primary

MeasureTime frame
SOFA score at Day 3, 7, 14;

Secondary

MeasureTime frame
Change of MVP at Day 3, 7, 14;Total mortality;Change of vasoactive drugs at Day 3, 7, 14;Change of CAI at Day 3, 7, 14;Change of PaO2/FiO2 at Day 3, 7, 14;Ventilator Free Day;AKI Morbidity;Change of inflammatory cytokines (IL-6, TNF-alpha);Change of Endotoxin;Length of ICU stay;

Countries

China

Contacts

Public ContactPing Fu
fupinghx@163.com+86 18980601201

Outcome results

None listed

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