Efficacy of Add-on Plasma Exchange As an Adjunctive Strategy Against Septic Shock
ConditionSeptic Shock
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorHannover Medical School
About this trial
Randomized, prospective, multicenter, open-label, controlled, parallel-group interventional trial to test the adjunctive effect of therapeutic plasma exchange in patients with early septic shock.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
New onset of septic shock (< 24 hrs), (SEPSIS-3 definition)
Norepinephrine (NE) dose ≥ 0.4 μg/kg/min ≥ 30 min OR NE ≥ 0.3 μg/kg/min + vasopressin (any dose)
Established vascular access suitable for plasma exchange independent of study inclusion (due to established indication of RRT, expected need for RRT within the next 48 hours or other medical reasons as assessed by treating physician team)
Disqualifiers
Age < 18 or > 80 years
Urogenital focus of infection
Pregnancy
Heparin-induced thrombocytopenia
Trial design
Design model
Parallel
Treatments tested in this trial
Therapeutic Plasma Exchange (TPE)
DeviceThe TPE treatment will be initiated within 6 hrs after randomization. Duration of TPE treatment is approximately 120-180 minutes. An additional second TPE can be performed if the patient remains vasopressor dependent ≥ 0.4 ug/kg/min after 24 hours following the first TPE procedure. Both unfractionated heparin (UFH) and citrate may be used as anticoagulant medication. To ensure treatment comparability between different patients, we will replace plasma in a fixed ratio of 1.2 x the individual patient's total plasma fluid.
Treatment groups
274 Participants
are divided into 2 treatment groupsGroup A: Therapeutic Plasma Exchange (TPE)Experimental treatment 1 intervention
Group B: Standard of Care (SOC)No intervention 0 interventions
Trial outcomes
Primary outcomes
1
28-day mortality
Time frame
from randomization up to 28 days following randomizationSecondary outcomes
1
Mean daily Sequential Organ Failure Score (SOFA) score over the first 7 days (KEY secondary outcome)
Per-patient mean daily SOFA score over the first 7 days, ranging from 0-24 points with higher scores indicating more severe organ dysfunction
Time frame
from randomization up to 7 days following randomization2
Organ support free days until day 28 (KEY secondary outcome)
total days free of invasive ventilation, vasopressors/inotrops and renal replacement therapy (RRT) until day 28
Time frame
from randomization up to 28 days following randomization3
90-day mortality
Time frame
from randomization up to 90 days following randomization4
Intensive Care unit (ICU) length of stay
total days in ICU
Time frame
from randomization until ICU dischargeOther outcomes
1
Safety Endpoints
includes: Incidence of bleeding, allergic reactions, Transfusion associated lung injury (TRALI), severe thrombocytopenia (\< 5000/µl) and (other) severe adverse events (SAEs)
Time frame
from randomization until day 7 following randomizationSponsors and contacts
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Source ClinicalTrials.gov