SepsisNCT03847961
Efficacy and Safety Study of CA330 Hemoadsorption Device on IL-6 Removal in Septic Patients
A study testing hemoperfusion with cytokine adsorption column (CA330) in people with Sepsis, run by First Affiliated Hospital, Sun Yat-Sen University at 1 site in China.
Trial 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 call for constant efforts to optimize therapy. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Sepsis
- What is being tested?
- hemoperfusion with cytokine adsorption column (CA330)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 144 participants
- Where
- 1 siteChina
- Study dates
- 17 Dec 2018to Oct 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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);
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- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
the First Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong, 510080
Xiangdong Guan, PhD, +8613802925067, carlg@163.net
Zhiyong Peng, PhD
About this study
Official title: Efficacy and Safety Study of CA330 Hemoadsorption Device on IL-6 Removal in Septic Patients: A Multicenter Randomized Controlled Trial
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 call for constant efforts to optimize therapy. At present, the definitive therapy is adequate antibiotics and infectious source control. Fortunately, research has led to a better understanding of the pathophysiology of sepsis, in which the activation of multiple pro- and anti-inflammatory mediators plays a key role. This has led to the development of treatment strategies aimed at restoring a balanced immune response by eliminating/deactivating these inflammatory mediators. Whilst animal models of sepsis have provided encouraging results with strategies aiming at immune response modulation, clinical studies in patients using targeted pharmacological approaches have so far proved disappointing.
Besides of acute kidney injury (AKI), renal replacement therapy (RRT) is applied to remove inflammatory mediators extracorporeally. Across the different modalities, the application of adsorption may help deactivate and decrease the peak elevation of these mediators in earlier course of sepsis, when levels of endotoxins and cytokines are extremely high. Recently, attempts to improve the outcome of sepsis patients with such devices, ie CytoSorb cytokine hemoadsorption and polymyxin B (Toraymyxin) endotoxin adsorption, have seen a certain renaissance. However, the clinical evidence to date supporting hemoadsorption for removal of endotoxins and/or proinflammatory mediators in sepsis remains incompetent and controversial.
CA330 (Jafron Biomedical Co , Ltd, Zhuhai, China) is a hemoadsorption device containing hemocompatible, porous polymeric beads capable of removing cytokines and other mid-molecular weight toxins from blood by size exclusion and surface adsorption. Compared with HA330, improved resin synthesis technology makes CA330 a better performance in removing cytokines. This trial is the first to evaluate CA330 efficacy of cytokine reduction using the change in plasma interleukin (IL)-6 concentrations over time as a primary outcome. Although the trial was neither designed nor powered to evaluate outcome, we also evaluated organ function parameters as well as 28-day all-cause mortality.
Read the 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 randomization is performed by researchers on the central randomization system, provided by the Department of Biostatistics, Southern Medical University. In this study, the center coded random number table is produced by stratified and sectional randomization method. Statistical Analysis System(SAS) 9.4 statistical software is used to generate random coding tables with serial numbers (001-144) according to the number of cases allocated in each center and the proportion of experimental group and control group (1:1). The length of selected sections (block) and random seed number are sealed together as confidential data . The random number table is provided by the statisticians of the Department of Biostatistics, Southern Medical University.
The experimental group receive routine treatment of sepsis combined with cytokine adsorption column (CA330) perfusion, and the control group receive routine treatment of sepsis only.
Hemoperfusion treatments are performed using a perfusion machine via centrally inserted standard dialysis catheters at a prescribed blood flow rate of 100-300ml/min. In the beginning, lower flow rate is recommended, if there is no discomfort, then gradually increases. Each patient received 2 hemoperfusion treatments within 24 hours with a target duration for each treatment of 120-180 minutes (minimum of 120 minutes). The shorter the interval between the two hemoperfusion is, the better. It is suggested that the second hemoperfusion be performed within 0-5 hours after the first one.
Anticoagulation was recommended with low-molecular-weight heparin in arterial line of the circuit at the dose of 60-80 international units (IU)/kg. No additional dose is required. The activity of anticoagulant factor α can be monitored at 60 minutes. It is suggested that the activity of anticoagulant factor α should be maintained at 500-1000units/L in subjects without bleeding tendency and 200-400units/L in subjects with bleeding tendency. If the clinical condition is limited, it is not mandatory to monitor this parameter.
- Conditions
- Sepsis
- Being tested
- hemoperfusion with cytokine adsorption column (CA330)
- Keywords
- sepsis, IL-6, hemoperfusion
- Medical subject headings
- Sepsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
hemoperfusion with cytokine adsorption column (CA330)Device
Hemoperfusion treatments are performed using a perfusion machine via centrally inserted standard dialysis catheters at a prescribed blood flow rate of 100-300ml/min. In the beginning, lower flow rate is recommended, if there is no discomfort, then gradually increases. Each patient received 2 hemoperfusion treatments within 24 hours with a target duration for each treatment of 120-180 minutes (minimum of 120 minutes). The shorter the interval between the two hemoperfusion is, the better. It is suggested that the second hemoperfusion be performed within 0-5 hours after the first one.
| Study group | Role | What they receive |
|---|---|---|
| Control Group | No intervention | The control group receive routine treatment of sepsis only. All sites agree, when feasible, to follow the tenets of the Surviving Sepsis Campaign clinical practice guidelines for management of sepsis. |
| Experimental Group | Experimental | The experimental group receive routine treatment of sepsis combined with hemoperfusion with cytokine adsorption column (CA330). Receives: Device: hemoperfusion with cytokine adsorption column (CA330) |
What is being measured
The primary outcome is the main question the study is designed to answer.
the reduction rate of IL-6 serum concentration at the initiation of first adsorption and at the end of the second adsorption
(1-Concentration IL-6 end of second adsorption/ Concentration IL-6 initiation of first adsorption) ×100%
Measured: from the initiation of first adsorption until the end of the second adsorption, assessed up to 24hours
Secondary outcomes (13)
the reduction rate of IL-10 serum concentration at the initiation of first adsorption and at the end of the second adsorption
(1-Concentration IL-10 end of second adsorption/ Concentration IL-10 initiation of first adsorption) ×100%
Measured: from the initiation of first adsorption until the end of the second adsorption, assessed up to 24hours
the reduction rate of lactic acid serum concentration at the initiation of first adsorption and at the end of the second adsorption
(1-Concentration lactic acid end of second adsorption/ Concentration lactic acid initiation of first adsorption) ×100%
Measured: from the initiation of first adsorption until the end of the second adsorption, assessed up to 24hours
the reduction rate of tumor necrosis factor-α (TNF-α) serum concentration at the initiation of first adsorption and at the end of the second adsorption
(1-Concentration TNF-α end of second adsorption/ Concentration TNF-α initiation of first adsorption) ×100%
Measured: from the initiation of first adsorption until the end of the second adsorption, assessed up to 24hours
the dynamic change of Acute Physiology and Chronic Health Evaluation (APACHE II) score
The maximum APACHE II score is 71, while the minimum score is 0. The higher values represent a worse outcome.
Measured: from Day0 to Day28
ventilation time
scale: hour
Measured: from Day0 to Day28
oxygenation index
partial pressure of oxygen to fraction of inspired oxygen (PaO2/FiO2)
Measured: from Day0 to Day28
24hour urinary output
scale: ml/24h
Measured: from Day0 to Day28
length of vasopressors
scale: hour
Measured: from Day0 to Day28
catecholamine index
(dopamine dose*1)+(dobutamine dose*1)+(adrenaline dose*100)+(noradrenaline dose*100)+(phenylephrine dose*100), wherein all doses are expressed as µg/kg/min.
Measured: from Day0 to Day28
RRT incidency
the percentages of patients who receive RRT in two groups
Measured: from Day0 to Day28
total length of renal replacement therapy
scale: hour
Measured: from Day0 to Day28
ICU and hospital length of stay
scale: day
Measured: from Day0 to Day28
28-day all-cause mortality
the 28-day all-cause mortality in two groups
Measured: from Day0 to Day28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2019
- Study start17 Dec 2018
- Primary completionFeb 2020 (estimated)
- Study completionOct 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SepsisStudies of the same condition, open and under way.
- More trials run by First Affiliated Hospital, Sun Yat-Sen UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model 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.
- Masking
- None (open label)
- Enrolment
- 144 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Sixth Affiliated Hospital, Sun Yat-sen University, Guangzhou First People's Hospital, Zhujiang Hospital, Beijing Chao Yang Hospital, Peking University Shenzhen Hospital, Fujian Provincial Hospital, Wuhan University
- Responsible party
- Principal investigator, Guan XiangDong, First Affiliated Hospital, Sun Yat-Sen University
- Investigators
- Xiangdong Guan, PhD, Principal investigator, First Affiliated Hospital, Sun Yat-Sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03847961
- Sponsor's protocol ID
- 2018-030-02
- Status last verified
- Feb 2019
- First submitted
- 13 Feb 2019
- Last updated
- 22 Feb 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety Study of CA330 Hemoadsorption Device on IL-6 Removal in Septic Patients: A Multicenter Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03847961
- Acronym / sponsor ID
- 2018-030-02
- Conditions
- Sepsis
- Keywords
- sepsis, IL-6, hemoperfusion
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 144 participants (estimated)
- Lead sponsor
- First Affiliated Hospital, Sun Yat-Sen UniversityUniversity, hospital or other
- Collaborators
- Sixth Affiliated Hospital, Sun Yat-sen University, Guangzhou First People's Hospital, Zhujiang Hospital, Beijing Chao Yang Hospital, Peking University Shenzhen Hospital, Fujian Provincial Hospital, Wuhan University
- Study start
- 17 Dec 2018 (actual)
- Primary completion
- Feb 2020 (estimated)
- Study completion
- Oct 2020 (estimated)
- First posted
- 20 Feb 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 call for constant efforts to optimize therapy. At present, the definitive therapy is adequate antibiotics and infectious source control. Fortunately, research has led to a better understanding of the pathophysiology of sepsis, in which the activation of multiple pro- and anti-inflammatory mediators plays a key role. This has led to the development of treatment strategies aimed at restoring a balanced immune response by eliminating/deactivating these inflammatory mediators. Whilst animal models of sepsis have provided encouraging results with strategies aiming at immune response modulation, clinical studies in patients using targeted pharmacological approaches have so far proved disappointing.
Besides of acute kidney injury (AKI), renal replacement therapy (RRT) is applied to remove inflammatory mediators extracorporeally. Across the different modalities, the application of adsorption may help deactivate and decrease the peak elevation of these mediators in earlier course of sepsis, when levels of endotoxins and cytokines are extremely high. Recently, attempts to improve the outcome of sepsis patients with such devices, ie CytoSorb cytokine hemoadsorption and polymyxin B (Toraymyxin) endotoxin adsorption, have seen a certain renaissance. However, the clinical evidence to date supporting hemoadsorption for removal of endotoxins and/or proinflammatory mediators in sepsis remains incompetent and controversial.
CA330 (Jafron Biomedical Co , Ltd, Zhuhai, China) is a hemoadsorption device containing hemocompatible, porous polymeric beads capable of removing cytokines and other mid-molecular weight toxins from blood by size exclusion and surface adsorption. Compared with HA330, improved resin synthesis technology makes CA330 a better performance in removing cytokines. This trial is the first to evaluate CA330 efficacy of cytokine reduction using the change in plasma interleukin (IL)-6 concentrations over time as a primary outcome. Although the trial was neither designed nor powered to evaluate outcome, we also evaluated organ function parameters as well as 28-day all-cause mortality.
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 randomization is performed by researchers on the central randomization system, provided by the Department of Biostatistics, Southern Medical University. In this study, the center coded random number table is produced by stratified and sectional randomization method. Statistical Analysis System(SAS) 9.4 statistical software is used to generate random coding tables with serial numbers (001-144) according to the number of cases allocated in each center and the proportion of experimental group and control group (1:1). The length of selected sections (block) and random seed number are sealed together as confidential data . The random number table is provided by the statisticians of the Department of Biostatistics, Southern Medical University.
The experimental group receive routine treatment of sepsis combined with cytokine adsorption column (CA330) perfusion, and the control group receive routine treatment of sepsis only.
Hemoperfusion treatments are performed using a perfusion machine via centrally inserted standard dialysis catheters at a prescribed blood flow rate of 100-300ml/min. In the beginning, lower flow rate is recommended, if there is no discomfort, then gradually increases. Each patient received 2 hemoperfusion treatments within 24 hours with a target duration for each treatment of 120-180 minutes (minimum of 120 minutes). The shorter the interval between the two hemoperfusion is, the better. It is suggested that the second hemoperfusion be performed within 0-5 hours after the first one.
Anticoagulation was recommended with low-molecular-weight heparin in arterial line of the circuit at the dose of 60-80 international units (IU)/kg. No additional dose is required. The activity of anticoagulant factor α can be monitored at 60 minutes. It is suggested that the activity of anticoagulant factor α should be maintained at 500-1000units/L in subjects without bleeding tendency and 200-400units/L in subjects with bleeding tendency. If the clinical condition is limited, it is not mandatory to monitor this parameter.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model 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.
| Arm | Type | Receives |
|---|---|---|
| Control Group | No intervention | –The control group receive routine treatment of sepsis only. All sites agree, when feasible, to follow the tenets of the Surviving Sepsis Campaign clinical practice guidelines for management of sepsis. |
| Experimental Group | Experimental | Device: hemoperfusion with cytokine adsorption column (CA330)The experimental group receive routine treatment of sepsis combined with hemoperfusion with cytokine adsorption column (CA330). |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (11 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| hemoperfusion with cytokine adsorption column (CA330)Hemoperfusion treatments are performed using a perfusion machine via centrally inserted standard dialysis catheters at a prescribed blood flow rate of 100-300ml/min. In the beginning, lower flow rate is recommended, if there is no discomfort, then gradually increases. Each patient received 2 hemoperfusion treatments within 24 hours with a target duration for each treatment of 120-180 minutes (minimum of 120 minutes). The shorter the interval between the two hemoperfusion is, the better. It is suggested that the second hemoperfusion be performed within 0-5 hours after the first one. | Device | Experimental Group |
Primary outcome
the reduction rate of IL-6 serum concentration at the initiation of first adsorption and at the end of the second adsorption
Time frame: from the initiation of first adsorption until the end of the second adsorption, assessed up to 24hours
(1-Concentration IL-6 end of second adsorption/ Concentration IL-6 initiation of first adsorption) ×100%
13 secondary outcomes
the reduction rate of IL-10 serum concentration at the initiation of first adsorption and at the end of the second adsorption
Time frame: from the initiation of first adsorption until the end of the second adsorption, assessed up to 24hours
the reduction rate of lactic acid serum concentration at the initiation of first adsorption and at the end of the second adsorption
Time frame: from the initiation of first adsorption until the end of the second adsorption, assessed up to 24hours
the reduction rate of tumor necrosis factor-α (TNF-α) serum concentration at the initiation of first adsorption and at the end of the second adsorption
Time frame: from the initiation of first adsorption until the end of the second adsorption, assessed up to 24hours
the dynamic change of Acute Physiology and Chronic Health Evaluation (APACHE II) score
Time frame: from Day0 to Day28
ventilation time
Time frame: from Day0 to Day28
oxygenation index
Time frame: from Day0 to Day28
24hour urinary output
Time frame: from Day0 to Day28
length of vasopressors
Time frame: from Day0 to Day28
catecholamine index
Time frame: from Day0 to Day28
RRT incidency
Time frame: from Day0 to Day28
total length of renal replacement therapy
Time frame: from Day0 to Day28
ICU and hospital length of stay
Time frame: from Day0 to Day28
28-day all-cause mortality
Time frame: from Day0 to Day28
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Feb 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Xiangdong Guan, PhD principal investigator
First Affiliated Hospital, Sun Yat-Sen University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing hemoperfusion with cytokine adsorption column (CA330) in people with Sepsis, run by First Affiliated Hospital, Sun Yat-Sen University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Zimeng Liu, PhD (+8618925002766 ext. 18826471751, sumslzm@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the reduction rate of IL-6 serum concentration at the initiation of first adsorption and at the end of the second adsorption (time frame: from the initiation of first adsorption until the end of the second adsorption, assessed up to 24hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Feb 2019.