Blood Purification in Patients With Septic Shock (NCT04957316) | Clinical Trial Compass
UnknownNot Applicable
Blood Purification in Patients With Septic Shock
Taiwan120 participantsStarted 2021-09-16
Plain-language summary
In recent years, many studies have pointed out that bacterial toxin storm and cytokine storm are the main causes of patients with septic shock and multiple organ dysfunction. Endotoxins are the main mediators of gram-negative bacteria causing systemic inflammation and sepsis. Endotoxins can interact with Toll- Like receptor 4 (TLR4) binding and trigger cytokine storms. The triple-effect blood purification filter has been proven to remove endotoxins, cytokines and urinary toxins, and it has the opportunity to improve shock in patients with sepsis. We hypothesize that blood purification using the three-effect filter can shorten the duration and severity of shock in patients with severe septic shock and reduce the organ damage by removing endotoxin, cytokine and urinary toxins. The primary aim of this study is to investigate the effect of blood purification using the three-effect filter on shortening the duration of septic shock. Other exploratory variables include the reduction of severity of organ damage and other clinical outcomes and prognosis.
Who can participate
Age range
20 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Critically ill patients with severe septic shock
* Intraabdominal infection, proved or highly suspected gram-negative bacteria infection
* Change of sequential organ failure assessment (SOFA) score is above or equal to 2
* Require norepinephrine infusion to maintain mean arterial pressure above 65 mm Hg
* Lactate level above 4 mmol/L
* SOFA score \>= 9 or norepinephrine dose \> 0.1 mcg/kg/min
Exclusion Criteria:
* Aged \< 20
* SOFA score \>=16
* Lactate level \>=16
* High dose norepinephrine infusion (\> 0.3 mcg/kg/min) more than 24 h after SOFA score was \>=9
* High dose norepinephrine infusion (\> 0.3 mcg/kg/min) more than 24 h after Lactate level was \>=4
* White blood cell counts \< 1000 cells/μL
* Platelet counts \< 30 K/μL
* Allergy to heparin
* Receive continuous renal replacement therapy \>8 hour before enrollment
* Receive other endotoxin removal filter
* Receive cardiopulmonary resuscitation within 4 weeks before enrollment
* Admitted to ICU for severe septic shock within 4 weeks before enrollment
* APACHE II score \> 35 at enrollment
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.