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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 below

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I need medication to keep my blood pressure above 65 mmHg.

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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

This trial's timeline: 3 weeks for screening, Varies for treatment, and during course of icu stay, could be up to 6 months for reporting.

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 more

Secondary outcome measures

Days in ICU

Mortality

Organ dysfunction

+3 more

Trial 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

0 / 3Eligibility criteria met

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

Therapeutic Plasma Exchange (Procedure) Clinical Trial Eligibility Overview. Trial Name: NCT04057872 — Phase 1

Septic Shock Research Study Groups: TPE in Septic Shock, Reference Population

Septic Shock Clinical Trial 2023: Therapeutic Plasma Exchange Highlights & Side Effects. Trial Name: NCT04057872 — Phase 1

Therapeutic Plasma Exchange (Procedure) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04057872 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any vacancies for potential participants in this clinical trial?

"Affirmative. Clinicaltrials.gov contains data which confirms that recruitment is currently underway for this trial, originally posted on October 21st 2020 and recently updated on February 15th 2022. 54 patients need to be recruited over the course of two medical sites."

Answered by AI

What is the aim of this experiment?

"This clinical trial, spanning up to 6 months, seeks to measure Adverse Events. Other metrics that will be monitored include Mortality, Hours of vasopressor support and Days on ventilator if applicable."

Answered by AI

How many individuals are taking part in this experiment?

"Affirmative. Per information hosted on clinicaltrials.gov, the study which was initially published October 21st 2020 is presently in need of participants. 54 patients must be enrolled from two different medical sites."

Answered by AI