CompletedPhase 1

Therapeutic Plasma Exchange in Adult Patients With Severe Sepsis

Canada17 participantsStarted 2020-10-21

Plain-language summary

The incidence of sepsis (severe infection) has increased over the last four decades. Severe sepsis and septic shock are among the leading causes of death for patients admitted to critical care units with mortality ranging from 20-70% depending on totality of organ dysfunction. Outside of antibiotics and good bedside care, little has changed in the management of this life-threatening problem. Therapeutic plasma exchange (TPE) involves the separation of plasma from whole blood. The removed plasma is 'exchanged or replaced' with either IV fluids, albumin, blood products or a combination thereof. The primary objective of this study is to evaluate the safety of the TPE intervention protocol within 24 hours of study criteria being met. TPE is now a well-established program at the South Health Campus for neuro-muscular disorders. Since starting in May 2018, the investigators have performed over 150 runs making the SHC ICU one of the most experienced centers in Canada.

Who can participate

Age range

18 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

. Core temperature \> 38oC or \< 36oC
. Heart rate \> 90 beats per minute
. Respiratory rate \> 20 breaths per minute, or PaCO2 \< 32 mmHg, or mechanical ventilation
. White cell count \> 12 x 109/L or \< 4 x 109/L or \> 10% immature neutrophils
. \>30 mls/kg fluid resuscitation
. Noradrenaline \>0.1 ug/kg/min to maintain MAP\> 65mmHg for at least 4 consecutive hours and present at initiation of TPE
. Lactate \>2 mmol/l.

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.

What they're measuring

Adverse Events

Timeframe: During course of ICU stay, could be up to 6 months

Discontinue TPE

Timeframe: During course of ICU stay, could be up to 6 months

Enrollment Rate

Timeframe: During course of ICU stay, could be up to 6 months

Protocol Completion

Timeframe: During course of ICU stay, could be up to 6 months

Trial details

NCT IDNCT04057872

SponsorAlberta Health Services, Calgary

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-12-31

View on ClinicalTrials.gov More Septic Shock trials

Plain-language summary

Who can participate

Age range

18 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

. Core temperature \> 38oC or \< 36oC
. Heart rate \> 90 beats per minute
. Respiratory rate \> 20 breaths per minute, or PaCO2 \< 32 mmHg, or mechanical ventilation
. White cell count \> 12 x 109/L or \< 4 x 109/L or \> 10% immature neutrophils
. \>30 mls/kg fluid resuscitation
. Noradrenaline \>0.1 ug/kg/min to maintain MAP\> 65mmHg for at least 4 consecutive hours and present at initiation of TPE
. Lactate \>2 mmol/l.

What they're measuring

Adverse Events

Timeframe: During course of ICU stay, could be up to 6 months

Discontinue TPE

Timeframe: During course of ICU stay, could be up to 6 months

Enrollment Rate

Timeframe: During course of ICU stay, could be up to 6 months

Protocol Completion

Timeframe: During course of ICU stay, could be up to 6 months