Therapeutic Plasma Exchange in Septic Shock: A Pilot Study (PLEXSIS)
Septic Shock
About this trial
This is an interventional treatment trial for Septic Shock focused on measuring Sepsis
Eligibility Criteria
Inclusion Criteria:
Eligible patients must be admitted to an ICU and must meet all of the following inclusion criteria:
- ≥ 18 years of age
- Refractory hypotension documented within 18 hours prior to enrolment requiring the institution and ongoing use of vasopressor agents (phenylephrine, norepinephrine, vasopressin, epinephrine, midodrine or dopamine >5 mcg/kg/min) at enrolment. Refractory hypotension is defined as a systolic blood pressure (SBP) less than 90 mmHg, or a SBP more than 30 mmHg below baseline, or a mean arterial blood pressure less than 65 mmHg, plus the receipt of ≥ 2 litres of intravenous fluid for the treatment of hypotension.
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, or ≥ 26.5 μmol/l increase or <0.5 ml/kg of urine output for 6-12 hours according to the KDIGO (Kidney Disease improving Global Outcomes) guideline definition of acute kidney injury.
- 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 enrolment
- Arterial pH < 7.30 or base deficit > 5 mmol/L in association with a lactate >/= to 4.0 mmol/L
Exclusion Criteria:
We will exclude patients who have any one of the following criteria at the time of enrolment:
- Consent declined (refusal from patient, SDM, or physician)
- Clinically apparent other forms of shock including cardiogenic, obstructive (e.g. massive pulmonary embolism, cardiac tamponade, tension pneumothorax), hemorrhagic, neurogenic, or anaphylactic
- Received vasopressor therapy for greater than 24 hours prior to enrolment
- Are currently enrolled in related trial
- Terminal illness with a life expectancy of less than 3 months
- Are pregnant
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Experimental
No Intervention
Treatment Arm
Standard of Care Arm
Participants randomized to treatment will received 1.0 plasma volume exchanges daily until discontinuation of vasopressors, death or to a maximum of 5 treatments. The management of septic shock, including but not limited to, antibiotic therapy, infection source control, fluid therapy, mechanical ventilation, and nutrition, will be at the discretion of the treating medical team, and will be recorded and reported.
Participants randomized to Standard-of-Care will be treated at the discretion of the treating medical team. The management of septic shock, including but not limited to, antibiotic therapy, infection source control, fluid therapy, mechanical ventilation, and nutrition, will be at the discretion of the treating medical team, and will be recorded and reported.