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RECRUITINGPhase 2INTERVENTIONAL

Therapeutic Plasma Exchange in Septic Shock: A Pilot Study

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

The investigators propose to conduct a multi-center randomized pilot feasibility trial comparing therapeutic plasma exchange to standard of care in patients diagnosed with septic shock.

Who May Be Eligible (Plain English)

Eligible patients must be admitted to an ICU and must meet all of the following Who May Qualify: 1. ≥ 16 years of age 2. Refractory hypotension documented within 48 hours prior to enrollment requiring the institution and ongoing use of vasopressor agents (phenylephrine, norepinephrine, vasopressin, epinephrine, midodrine or dopamine \>5 mcg/kg/min) at enrollment. Refractory hypotension is defined as a systolic blood pressure (SBP) less than 90 mmHg, or SBP less than 30 mmHg below baseline, or a mean arterial blood pressure less than 65 mmHg, despite adequate fluid resuscitation 3. Capacity to initiate plasma exchange with 48 hours of vasopressor initiation. 4. At least 1 other new organ dysfunction (in addition to refractory hypotension), defined by the following at the time of enrollment: 1. Creatinine ≥1.5x the known baseline creatinine within 7 days, or ≥ 26.5 µmol/l increase in 48 hours, 2. Need for invasive mechanical ventilation or a P/F ratio \<250 3. Platelets \<100 x109/L, or a drop of 50 x109/L in the 3 days prior to enrollment 4. Arterial pH \< 7.30 or base deficit \> 5 mmol/L in association with a lactate \>/= to 3.0 mmol/L 45\. Known or suspected infection 2.4.3 Exclusion criteria We will exclude patients who have any one of the following criteria at the time of enrollment: 1. Consent declined (refusal from patient, SDM, or physician) 2. Clinically apparent alternate causes for shock (cardiogenic, hemorrhagic, obstructive, neurogenic or anaphylactic) 3. Terminal illness with a life expectancy of less than 3 months 4. Are pregnant Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
Eligible patients must be admitted to an ICU and must meet all of the following inclusion criteria: 1. ≥ 16 years of age 2. Refractory hypotension documented within 48 hours prior to enrollment requiring the institution and ongoing use of vasopressor agents (phenylephrine, norepinephrine, vasopressin, epinephrine, midodrine or dopamine \>5 mcg/kg/min) at enrollment. Refractory hypotension is defined as a systolic blood pressure (SBP) less than 90 mmHg, or SBP less than 30 mmHg below baseline, or a mean arterial blood pressure less than 65 mmHg, despite adequate fluid resuscitation 3. Capacity to initiate plasma exchange with 48 hours of vasopressor initiation. 4. At least 1 other new organ dysfunction (in addition to refractory hypotension), defined by the following at the time of enrollment: 1. Creatinine ≥1.5x the known baseline creatinine within 7 days, or ≥ 26.5 µmol/l increase in 48 hours, 2. Need for invasive mechanical ventilation or a P/F ratio \<250 3. Platelets \<100 x109/L, or a drop of 50 x109/L in the 3 days prior to enrollment 4. Arterial pH \< 7.30 or base deficit \> 5 mmol/L in association with a lactate \>/= to 3.0 mmol/L 45\. Known or suspected infection 2.4.3 Exclusion criteria We will exclude patients who have any one of the following criteria at the time of enrollment: 1. Consent declined (refusal from patient, SDM, or physician) 2. Clinically apparent alternate causes for shock (cardiogenic, hemorrhagic, obstructive, neurogenic or anaphylactic) 3. Terminal illness with a life expectancy of less than 3 months 4. Are pregnant

Treatments Being Tested

OTHER

Therapeutic Plasma Exchange

TPE procedures will be performed using a Spectra Optia ® apheresis machine (Terumo BCT, Lakewood, USA) according to usual-care procedures for apheresis. Venous access for the TPE procedures will be obtained through a double lumen dialysis catheter to provide adequate flow rates required for TPE. Regional citrate anticoagulation will be used for anticoagulation within the apheresis circuit. One to two grams of calcium chloride will be infused as per standard during TPE to prevent symptomatic hypocalcemia. Plasma volume will be calculated as per a standard formula whereby estimated plasma volume (in liters) = 0.07 x weight (kg) x (1 - hematocrit). In patients on dialysis, dialysis will be interrupted for the duration of the procedure. Antibiotics will be given after TPE to avoid clearance of the antibiotics. On the first day of TPE, a repeat dose of antibiotics will be administered after completion of TPE. Nurse clinicians trained in TPE will perform the TPE procedures.

Locations (11)

Foothills Medical Centre
Calgary, Alberta, Canada
Southern Health Campus
Calgary, Alberta, Canada
University of Alberta
Edmonton, Alberta, Canada
University of Manitoba
Winnipeg, Manitoba, Canada
Hamilton Health Sciences - Juravinski
Hamilton, Ontario, Canada
St. Joseph's Hospital
Hamilton, Ontario, Canada
Queen's University at Kingston
Kingston, Ontario, Canada
Ottawa Hospital
Ottawa, Ontario, Canada
St. Michael's Hospital
Toronto, Ontario, Canada
Centre Hospitalier de L'Université de Montréal (Chum),
Montreal, Quebec, Canada
Universite Laval
Québec, Quebec, Canada