Status:
UNKNOWN
Efficacy and Safety Study of CA330 Hemoadsorption Device on IL-6 Removal in Septic Patients
Lead Sponsor:
First Affiliated Hospital, Sun Yat-Sen University
Collaborating Sponsors:
Sixth Affiliated Hospital, Sun Yat-sen University
Guangzhou First People's Hospital
Conditions:
Sepsis
Eligibility:
All Genders
18-75 years
Phase:
NA
Brief Summary
Sepsis persists to be the leading causes of morbidity and mortality worldwide. Moreover, the magnitude of health care resources utilized when managing septic patients is huge. All these hard facts cal...
Detailed Description
Eligible patients are stratified by site and randomly assigned in a 1:1 ratio to either CA330 hemoperfusion plus conventional medical therapy group or conventional medical therapy group. The randomiza...
Eligibility Criteria
Inclusion
- Hospitalized patients aged 18-75 years, regardless of gender;
- Meet the clinical criteria of sepsis according to the Third International Consensus Definitions for Sepsis;
- The diagnosis of sepsis is established within last 48 hours.
- Written informed consent is signed, and agreement to participate in all visits, examinations and treatments as required by the research program is achieved. If a patient is not able to give consent, the legal representative is asked to consent.
Exclusion
- End-stage renal disease that need maintenance hemodialysis treatment;
- Congenital or acquired immunodeficiency disorders or those who had received organ transplantation within one year;
- Prescription of immunosuppressive medications (tripterygium wilfordii, mycophenolate mofetil, cyclophosphamide, FK506, etc.) or prednisolone for more than 10 mg/day (or the same dose of other hormone therapy) within 30 days;
- Coagulation dysfunction, severe bleeding tendency (prothrombin time, activated partial thromboplastin time prolonged significantly with bleeding, or fibrinogen less than 1.2 g/L with bleeding), active bleeding or uncontrolled acute massive bleeding within 24 hours;
- Malignant tumors, consumptive diseases, site of infection cannot be cleared (ie surgical patients who cannot be operated on) or body weight less than 35kg;
- A terminal state of organ failure (end stage of chronic obstructive pulmonary disease, pulmonary heart disease, heart dysfunction stage-IV, brain death or persistent vegetative state, chronic liver disease with hepatic encephalopathy, coagulation dysfunction, fluid retention and hepatocellular jaundice);
- Following results are detected during screening: platelet count \< 50 \*10\^9/L, neutrophil count \< 0.5 \*10\^9/L, hemoglobin \< 70 g/L;
- Despite of adequate volume resuscitation, vasopressors and hormones, the mean arterial blood cannot maintain above 65 mmHg;
- Those who have been participating in or participated in another interventional clinical study within 30 days prior to enrollment, such as the clinical study of related drugs or medical devices affecting immunity (ie Xuebijing, ulinastatin, continuous renal replacement therapy, etc.);
- Anaphylaxis to materials of cardiopulmonary bypass, anticoagulants and hemoperfusion or other serious allergic history;
- Those who are not suitable for this clinical trial, which is determined by researchers, such as pregnant or lactating women, current drug addicts, patients with severe mental or neurological disorders, and those who have a history of alcohol abuse and cannot be terminated.
Key Trial Info
Start Date :
December 17 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2020
Estimated Enrollment :
144 Patients enrolled
Trial Details
Trial ID
NCT03847961
Start Date
December 17 2018
End Date
October 1 2020
Last Update
February 22 2019
Active Locations (1)
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1
the First Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong, China, 510080