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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT03844542
Other study ID # 18-1187
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date June 2019
Est. completion date June 2023

Study information

Verified date February 2019
Source Forsyth Medical Center
Contact Philip Keith, MD
Phone 843.693.0412
Email pkeith@salemchest.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The investigators prospective, randomized adult clinical trial investigates the therapeutic efficacy of early therapeutic plasma exchange as adjunct treatment to standard therapy in patients with refractory septic shock and multiple organ failure.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 300
Est. completion date June 2023
Est. primary completion date December 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Adult patients are eligible for inclusion if they have sepsis with refractory shock and evidence of organ failure.

Exclusion Criteria:

- Persons who are pregnant

- Persons who are incarcerated

- Acute surgical catastrophe without potential for intervention or source control

- Cardiac arrest with unknown neurologic status, including patients being treated with therapeutic hypothermia

- Presence of severe acute brain injury or severe dementia

- Cardiogenic, neurogenic, obstructive, or post-cardiotomy shock

- Acute pancreatitis with no established source of infection

- Diabetic ketoacidosis as primary pathology

- Note: Septic patients who develop DKA are eligible for inclusion. However, patients in whom organ dysfunction and hemodynamic instability are due primarily to volume depletion and acidosis from DKA should not be included.

- Need for mechanical circulatory support

- Prolonged acute illness with > 24 hours of pressor needs at enrollment and/or end organ damage with further care deemed to be "futile."

- NOTE: The time resets if a new inciting event leads to SAMOF.

- For example, if a patient has sepsis stabilized but requires operative intervention for source control within the initial 24 hours of admission and returns to the ICU with SAMOF, the patient is again eligible for randomization for the next 24 hours.

- Bedbound state or poor baseline functional status with ECOG performance status score = 3

- Underlying terminal illness/malignancy with < 6 months life expectancy

- Advanced chronic liver disease/cirrhosis with evidence of portal hypertension

- Asplenia

- HIV with HARRT non-compliance

Study Design


Related Conditions & MeSH terms


Intervention

Device:
Therapeutic plasma exchange
Perform therapeutic plasma exchange in patients with sepsis induced multi-organ failure

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Forsyth Medical Center

Outcome

Type Measure Description Time frame Safety issue
Primary 28-Day Mortality 28 days 28 days
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