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Procedure
Therapeutic Plasma Exchange for Sepsis
Phase 1
Recruiting
Led By George F Alvarez, MD
Research Sponsored by Alberta Health Services, Calgary
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Noradrenaline >0.1 ug/kg/min to maintain MAP> 65mmHg for at least 4 consecutive hours and present at initiation of TPE
Adult patients (age ≥18) with a documented or strong clinical suspicion of infection that meets the definition of septic shock as per the Third International Consensus Definitions for Sepsis and Septic Shock (Sepsis-3).
Timeline
Screening 3 weeks
Treatment Varies
Follow Up during course of icu stay, could be up to 6 months
Awards & highlights
Study Summary
This trial will help to establish the safety of TPE as a therapy for sepsis.
Who is the study for?
Adults over 18 with severe sepsis or septic shock, showing signs of inflammation and infection. They must have a high risk of hospital mortality, need significant fluid resuscitation and drugs to maintain blood pressure, and may require mechanical ventilation. Those not committed to active treatment or near death are excluded.Check my eligibility
What is being tested?
The trial is testing the safety of Therapeutic Plasma Exchange (TPE) within 24 hours for patients with severe sepsis. TPE removes plasma from blood and replaces it with other fluids or products. The study leverages experience from a Canadian ICU experienced in TPE for neuro-muscular disorders.See study design
What are the potential side effects?
While specific side effects are not listed here, TPE procedures can generally involve risks such as allergic reactions to replacement fluids, bleeding due to anticoagulants used during the process, infections at catheter sites, or changes in blood pressure.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I need medication to keep my blood pressure above 65 mmHg.
Select...
I am an adult suspected of or diagnosed with septic shock.
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I have received more than 30 mls/kg in fluid resuscitation.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ during course of icu stay, could be up to 6 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~during course of icu stay, could be up to 6 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Adverse Events
Discontinue TPE
Enrollment Rate
+1 moreSecondary outcome measures
Days in ICU
Mortality
Organ dysfunction
+3 moreTrial Design
2Treatment groups
Active Control
Group I: TPE in Septic ShockActive Control1 Intervention
The patients in this arm will receive TPE
Group II: Reference PopulationActive Control1 Intervention
The patients will receive the standard of care for septic shock treatment
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
The most common treatments for septic shock include fluid resuscitation, antibiotic therapy, and therapeutic plasma exchange (TPE). Fluid resuscitation restores tissue perfusion by rapidly administering intravenous fluids to maintain blood pressure and organ function.
Antibiotic therapy targets and eliminates the infection, reducing the bacterial load and inflammatory response. TPE involves removing the patient's plasma, which contains harmful substances like inflammatory mediators and endotoxins, and replacing it with IV fluids, albumin, or blood products.
This helps reduce the systemic inflammatory response and improve hemodynamic stability. These treatments are crucial as they address both the infection and the resulting hemodynamic instability, key factors in reducing mortality and improving outcomes for septic shock patients.
Plasma Leak From the Circulation Contributes to Poor Outcomes for Preterm Infants: A Working Hypothesis.Extracorporeal blood treatment (EBT) methods in SIRS/Sepsis.
Plasma Leak From the Circulation Contributes to Poor Outcomes for Preterm Infants: A Working Hypothesis.Extracorporeal blood treatment (EBT) methods in SIRS/Sepsis.
Find a Location
Who is running the clinical trial?
Alberta Health Services, CalgaryLead Sponsor
13 Previous Clinical Trials
2,547 Total Patients Enrolled
George F Alvarez, MDPrincipal InvestigatorAlberta Health services
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I need medication to keep my blood pressure above 65 mmHg.I am an adult suspected of or diagnosed with septic shock.We will exclude participants who have a high chance of dying in the hospital, more than 40%.I have received more than 30 mls/kg in fluid resuscitation.I show at least two signs of inflammation.
Research Study Groups:
This trial has the following groups:- Group 1: TPE in Septic Shock
- Group 2: Reference Population
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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