BridgeMD
New treatment option for Septic Shock
Official title Therapeutic Plasma Exchange in Septic Shock: A Pilot Study
ClinicalTrials.gov ID: NCT05093075
What this study is testing
- What it's testing
- The investigators propose to conduct a multi-center randomized pilot feasibility trial comparing therapeutic plasma exchange to standard of care in patients diagnosed with septic shock.
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 16 and older
You may be able to join if
- Eligible patients must be admitted to an ICU and must meet all of the following
- ≥ 16 years of age
- Refractory hypotension documented within 48 hours prior to enrollment requiring the institution and ongoing use of vasopressor agents (phenylephrine...
- Capacity to initiate plasma exchange with 48 hours of vasopressor initiation.
- At least 1 other new organ dysfunction (in addition to refractory hypotension), defined by the following at the time of enrollment:
You likely can't join if
- We will exclude patients who have any one of the following criteria at the time of enrollment:
- Consent declined (refusal from patient, SDM, or physician)
- Clinically apparent alternate causes for shock (cardiogenic, hemorrhagic, obstructive, neurogenic or anaphylactic)
- Terminal illness with a life expectancy of less than 3 months
- Are pregnant
See the full eligibility criteria
- Eligible patients must be admitted to an ICU and must meet all of the following
- ≥ 16 years of age
- Refractory hypotension documented within 48 hours prior to enrollment requiring the institution and ongoing use of vasopressor agents (phenylephrine, norepinephrine, vasopressin, epinephrine, midodrine or dopamine \>5...
- Capacity to initiate plasma exchange with 48 hours of vasopressor initiation.
- At least 1 other new organ dysfunction (in addition to refractory hypotension), defined by the following at the time of enrollment:
- Creatinine ≥1.5x the known baseline creatinine within 7 days, or ≥ 26.5 µmol/l increase in 48 hours,
- Need for invasive mechanical ventilation or a P/F ratio \<250
- Platelets \<100 x109/L, or a drop of 50 x109/L in the 3 days prior to enrollment
- Arterial pH \ 5 mmol/L in association with a lactate \>/= to 3.0 mmol/L 45\. Known or suspected infection 2.4.3
- We will exclude patients who have any one of the following criteria at the time of enrollment:
- Consent declined (refusal from patient, SDM, or physician)
- Clinically apparent alternate causes for shock (cardiogenic, hemorrhagic, obstructive, neurogenic or anaphylactic)
- Terminal illness with a life expectancy of less than 3 months
- Are pregnant
The study team makes the final eligibility decision.
Where it's taking place
- Calgary, Alberta, Canada
- Edmonton, Alberta, Canada
- Winnipeg, Manitoba, Canada
- Hamilton, Ontario, Canada
- Kingston, Ontario, Canada
- Ottawa, Ontario, Canada
- Toronto, Ontario, Canada
- Montreal, Quebec, Canada
- Québec, Quebec, Canada
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 16 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Calgary, Alberta, Canada; Edmonton, Alberta, Canada; Winnipeg, Manitoba, Canada; Hamilton, Ontario, Canada; Kingston, Ontario, Canada; Ottawa, Ontario, Canada and 3 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.