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Status unknownNCT03847961Updated Feb 22, 2019

Efficacy and Safety Study of CA330 Hemoadsorption Device on IL-6 Removal in Septic Patients

An interventional study of hemoperfusion with cytokine adsorption column (CA330) in Sepsis, sponsored by First Affiliated Hospital, Sun Yat-Sen University. Status unknown at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2019-02-22.

Sponsored by First Affiliated Hospital, Sun Yat-Sen University · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Feb 2019), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
144
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
01

Study 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. 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.

02

Conditions studied

  • Sepsis

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Keywords

  • sepsis
  • IL-6
  • hemoperfusion
03

In context

Sepsis

1,946 studies on the registry are indexed under Sepsis; 471 are open to participants now.

This study's planned enrollment of 144 is above the median of 105 across 918 interventional studies indexed under Sepsis.

Browse Sepsis studies →

Lead sponsor

First Affiliated Hospital, Sun Yat-Sen University is the lead sponsor of 161 studies on the registry; 54 are open to participants now.

Browse First Affiliated Hospital, Sun Yat-Sen University studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Hospitalized patients aged 18-75 years, regardless of gender;
  2. Meet the clinical criteria of sepsis according to the Third International Consensus Definitions for Sepsis;
  3. The diagnosis of sepsis is established within last 48 hours.
  4. 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 criteria

Exclusion Criteria:

  1. End-stage renal disease that need maintenance hemodialysis treatment;
  2. Congenital or acquired immunodeficiency disorders or those who had received organ transplantation within one year;
  3. 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;
  4. 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;
  5. Malignant tumors, consumptive diseases, site of infection cannot be cleared (ie surgical patients who cannot be operated on) or body weight less than 35kg;
  6. 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);
  7. Following results are detected during screening: platelet count \< 50 *10\^9/L, neutrophil count \< 0.5 *10\^9/L, hemoglobin \< 70 g/L;
  8. Despite of adequate volume resuscitation, vasopressors and hormones, the mean arterial blood cannot maintain above 65 mmHg;
  9. 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.);
  10. Anaphylaxis to materials of cardiopulmonary bypass, anticoagulants and hemoperfusion or other serious allergic history;
  11. 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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
144 participants (estimated)

Study arms

  • No intervention
    Control Group

    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
    Experimental Group

    The experimental group receive routine treatment of sepsis combined with hemoperfusion with cytokine adsorption column (CA330).

    Device: hemoperfusion with cytokine adsorption column (CA330)

Interventions

  • Devicehemoperfusion 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.

06

What researchers measure

Primary outcomes

  1. 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%

    Time frame: from the initiation of first adsorption until the end of the second adsorption, assessed up to 24hours

Secondary outcomes

  1. 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%

    Time frame: from the initiation of first adsorption until the end of the second adsorption, assessed up to 24hours

  2. 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%

    Time frame: from the initiation of first adsorption until the end of the second adsorption, assessed up to 24hours

  3. 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%

    Time frame: from the initiation of first adsorption until the end of the second adsorption, assessed up to 24hours

  4. 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.

    Time frame: from Day0 to Day28

  5. ventilation time

    scale: hour

    Time frame: from Day0 to Day28

  6. oxygenation index

    partial pressure of oxygen to fraction of inspired oxygen (PaO2/FiO2)

    Time frame: from Day0 to Day28

  7. 24hour urinary output

    scale: ml/24h

    Time frame: from Day0 to Day28

  8. length of vasopressors

    scale: hour

    Time frame: from Day0 to Day28

  9. 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.

    Time frame: from Day0 to Day28

  10. RRT incidency

    the percentages of patients who receive RRT in two groups

    Time frame: from Day0 to Day28

  11. total length of renal replacement therapy

    scale: hour

    Time frame: from Day0 to Day28

  12. ICU and hospital length of stay

    scale: day

    Time frame: from Day0 to Day28

  13. 28-day all-cause mortality

    the 28-day all-cause mortality in two groups

    Time frame: from Day0 to Day28

Other outcomes

  1. body temperature

    scale: ℃

    Time frame: from Day0 to Day28

  2. heart rate

    scale: beats per minute (bpm)

    Time frame: from Day0 to Day28

  3. respiratory rate

    scale: times per minute

    Time frame: from Day0 to Day28

  4. blood pressure

    Both systolic and diastolic pressure will be measured. Scale: mmHg

    Time frame: from Day0 to Day28

  5. count of white blood cell

    scale: cells/L

    Time frame: from Day0 to Day28

  6. count of neutrophils

    scale: cells/L

    Time frame: from Day0 to Day28

  7. concentration of hemoglobin

    scale: g/dl

    Time frame: from Day0 to Day28

  8. hematocrit value

    hematocrit value

    Time frame: from Day0 to Day28

  9. count of platelet

    scale: cells/L

    Time frame: from Day0 to Day28

  10. prothrombin time (PT)

    scale: second

    Time frame: from Day0 to Day28

  11. activated partial thromboplastin time (APPT)

    scale: second

    Time frame: from Day0 to Day28

  12. level of fibrinogen

    scale: g/dl

    Time frame: from Day0 to Day28

  13. thrombin time (TT)

    scale: second

    Time frame: from Day0 to Day28

  14. level of serum Alanine transaminase (ALT)

    scale: Unit/L (U/L)

    Time frame: from Day0 to Day28

  15. level of serum Aspartate transaminase (AST)

    scale: Unit/L (U/L)

    Time frame: from Day0 to Day28

  16. level of total bilirubin

    scale: µmol/L

    Time frame: from Day0 to Day28

  17. level of direct bilirubin

    scale: µmol/L

    Time frame: from Day0 to Day28

  18. level of total protein

    scale: g/L

    Time frame: from Day0 to Day28

  19. level of albumin

    scale: g/L

    Time frame: from Day0 to Day28

  20. concentration of serum creatinine

    scale: mg/dl

    Time frame: from Day0 to Day28

  21. concentration of blood urea nitrogen

    scale: mmol/L

    Time frame: from Day0 to Day28

  22. concentration of serum potassium

    scale: mmol/L

    Time frame: from Day0 to Day28

  23. concentration of serum sodium

    scale: mmol/L

    Time frame: from Day0 to Day28

  24. concentration of serum calcium

    scale: mmol/L

    Time frame: from Day0 to Day28

  25. concentration of serum phosphorus

    scale: mmol/L

    Time frame: from Day0 to Day28

  26. concentration of serum magnesium

    scale: mmol/L

    Time frame: from Day0 to Day28

07

Study locations

1 of 1 sites recruiting
  • the First Affiliated Hospital of Sun Yat-sen University
    Guangzhou, Guangdong 510080, China
    • Xiangdong Guan, PhD · Contact · carlg@163.net · +8613802925067
    • Zhiyong Peng, PhD · Principal investigator
    • Qiuye Kou, PhD · Principal investigator
    • Weixing Zhang, PhD · Principal investigator
    • Rongguo Yu, PhD · Principal investigator
    • Zhanguo Liu, PhD · Principal investigator
    • Jun Zeng, PhD · Principal investigator
    • Wenxiong Li, PhD · Principal investigator
    Recruiting
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Dec 2018 (actual). Primary completion is estimated for Feb 2020, 14 months after the start.

Of 246 non-industry interventional studies with no phase under Sepsis, half reached primary completion within 22 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 44. This study's planned 14 months is below that.

Counting every sponsor, half of 267 studies reached it within 22 months; a quarter within 12 and three quarters within 43.

How these figures are worked out, and which studies are left out of them.

Registered
Feb 13, 2019
First posted
Feb 20, 2019
StartActual
Dec 17, 2018
Primary completionEst.
Feb 2020
CompletionEst.
Oct 2020
Last update
Feb 22, 2019
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Feb 22, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03847961
Lead sponsor
First Affiliated Hospital, Sun Yat-Sen University
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
Guan XiangDong (Chief of the Department of Critical Care Medicine, Chairman of the Chinese Society of Critical Care Medicine, First Affiliated Hospital, Sun Yat-Sen University) — Principal investigator
First posted
Feb 20, 2019
Start date
Dec 17, 2018
Primary completion
Feb 2020 (estimated)
Completion
Oct 2020 (estimated)
Last update
Feb 22, 2019

Study contacts

Zimeng Liu, PhD
Contact
sumslzm@163.com
+8618925002766 ext. 18826471751
Yao Nie, PhD
Contact
nieyao850622@126.com
+8618826471751 ext. 18826471751
Xiangdong Guan, PhD
principal investigator · First Affiliated Hospital, Sun Yat-Sen University

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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