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Therapeutic Plasma Exchange in Adult Patients With Severe Sepsis

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ClinicalTrials.gov Identifier: NCT04057872
Recruitment Status : Recruiting
First Posted : August 15, 2019
Last Update Posted : February 17, 2022
Sponsor:
Information provided by (Responsible Party):
Dr. George Alvarez, Alberta Health Services, Calgary

Brief 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.


Condition or disease Intervention/treatment Phase
Septic Shock Procedure: Therapeutic plasma exchange Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 54 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Consecutive Adults patients with vasoplegic septic shock with at least 2 organ dysfunction will receive TPE
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: PILOT STUDY in the Use of Therapeutic Plasma Exchange in Adult Patients With Severe Sepsis
Actual Study Start Date : October 21, 2020
Estimated Primary Completion Date : December 31, 2023
Estimated Study Completion Date : December 31, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sepsis Shock

Arm Intervention/treatment
Active Comparator: TPE in Septic Shock
The patients in this arm will receive TPE
Procedure: Therapeutic plasma exchange
The removed plasma is 'exchanged or replaced' with either IV fluids, albumin, and/or Fresh frozen plasma

No Intervention: Reference Population
The patients will receive the standard of care for septic shock treatment



Primary Outcome Measures :
  1. Adverse Events [ Time Frame: During course of ICU stay, could be up to 6 months ]
    Proportion of patients who experience at least 1 Adverse Event (AE)

  2. Discontinue TPE [ Time Frame: During course of ICU stay, could be up to 6 months ]
    Proportion of patients who discontinue TPE administration due to an AE

  3. Enrollment Rate [ Time Frame: During course of ICU stay, could be up to 6 months ]
    3. Enrollment rate (patients screened, patients eligible, patients approached, patients enrolled)

  4. Protocol Completion [ Time Frame: During course of ICU stay, could be up to 6 months ]
    Protocol completion (patients who complete study protocol)


Secondary Outcome Measures :
  1. Organ dysfunction [ Time Frame: During course of ICU stay, could be up to 6 months ]
    Resolution or worsening of organ dysfunction as per SOFA score

  2. Vasopressor support [ Time Frame: During course of ICU stay, could be up to 6 months ]
    Hours of vasopressor support

  3. Ventilator support [ Time Frame: During course of ICU stay, could be up to 6 months ]
    Days on ventilator if applicable

  4. Days in ICU [ Time Frame: During course of ICU stay, could be up to 6 months ]
    Days in ICU (censored to day ready for discharge)

  5. Mortality [ Time Frame: During course of ICU stay, could be up to 6 months ]
    Mortality

  6. RRT Required [ Time Frame: During course of ICU stay, could be up to 6 months ]
    Need for RRT



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria 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).

Exhibiting two of the four clinical signs of inflammation:

  1. Core temperature > 38oC or < 36oC
  2. Heart rate > 90 beats per minute
  3. Respiratory rate > 20 breaths per minute, or PaCO2 < 32 mmHg, or mechanical ventilation
  4. White cell count > 12 x 109/L or < 4 x 109/L or > 10% immature neutrophils

We will further identify the subset with a hospital mortality in excess of 40%:

  1. >30 mls/kg fluid resuscitation
  2. Noradrenaline >0.1 ug/kg/min to maintain MAP> 65mmHg for at least 4 consecutive hours and present at initiation of TPE
  3. Lactate >2 mmol/l.

Exclusion Criteria Patients will be excluded in cases where death is deemed inevitable or imminent during admission and either the attending physician, patient or surrogate legal decision maker is not committed to active treatment.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04057872


Contacts
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Contact: George F Alvarez, MD 403-956-2113 ext 4039562113 George.Alvarez@ahs.ca
Contact: Miranda Kavalench 403-956-2113 ext 4039562113 Miranda.Kavalench@ahs.ca

Locations
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Canada, Alberta
Peter Lougheed Centre Recruiting
Calgary, Alberta, Canada, T3M 1M4
Contact: George Alvarez    4039562113    george.alvarez@ahs.ca   
South Health Campus Recruiting
Calgary, Alberta, Canada, T3M 1M4
Contact: George Alvarez    4039562113    george.alvarez@ahs.ca   
Sponsors and Collaborators
Alberta Health Services, Calgary
Investigators
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Principal Investigator: George F Alvarez, MD Alberta Health services
Publications:
Rhodes A, Evans LE, Alhazzani W, Levy MM, Antonelli M, Ferrer R, Kumar A, Sevransky JE, Sprung CL, Nunnally ME, Rochwerg B, Rubenfeld GD, Angus DC, Annane D, Beale RJ, Bellinghan GJ, Bernard GR, Chiche JD, Coopersmith C, De Backer DP, French CJ, Fujishima S, Gerlach H, Hidalgo JL, Hollenberg SM, Jones AE, Karnad DR, Kleinpell RM, Koh Y, Lisboa TC, Machado FR, Marini JJ, Marshall JC, Mazuski JE, McIntyre LA, McLean AS, Mehta S, Moreno RP, Myburgh J, Navalesi P, Nishida O, Osborn TM, Perner A, Plunkett CM, Ranieri M, Schorr CA, Seckel MA, Seymour CW, Shieh L, Shukri KA, Simpson SQ, Singer M, Thompson BT, Townsend SR, Van der Poll T, Vincent JL, Wiersinga WJ, Zimmerman JL, Dellinger RP. Surviving Sepsis Campaign: International Guidelines for Management of Sepsis and Septic Shock: 2016. Intensive Care Med. 2017 Mar;43(3):304-377. doi: 10.1007/s00134-017-4683-6. Epub 2017 Jan 18.

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Responsible Party: Dr. George Alvarez, Intensivist, Department of Critical Care Medicine, Alberta Health Services, Calgary
ClinicalTrials.gov Identifier: NCT04057872    
Other Study ID Numbers: REB19-1157
First Posted: August 15, 2019    Key Record Dates
Last Update Posted: February 17, 2022
Last Verified: February 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Once the results have been analyzed and published the de-identified data will be made available to other researchers
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Clinical Study Report (CSR)
Time Frame: The data will be made available once published. It will be made available for 5 years as per University of Calgary data storage protocol.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Dr. George Alvarez, Alberta Health Services, Calgary:
Therapeutic Plasma Exchange (TPE)
Septic Shock
Severe Sepsis
Albumin
Fresh Frozen Plasma
Additional relevant MeSH terms:
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Sepsis
Shock, Septic
Infections
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes
Shock