Vasculopathic Injury and Plasma as Endothelial Rescue in Septic Shock (SHOCK) Trial

This is a single center, randomized (1:1, active : standard of care), controlled, open-label, investigator-initiated pilot phase IIa trial in patients with septic shock investigating the efficacy and safety of administrating OctaplasLG® as compared to crystalloids, such as Ringer-Acetate (standard of care) in a total of 40 patients.

40 patients will be enrolled:

• Patients in the active treatment group (n = 20 patients) will receive OctaplasLG® as volume support according to trial algorithm.
• Patients in the standard of care group (n = 20 patients) will receive crystalloids, such as Ringer-Acetate, as volume support according to trial algorithm.

All patients will be treated according to the standard ICU care.

Inclusion criteria

• Adult intensive care patients (age ≥ 18 years) AND
• Sepsis, defined as life-threatening organ dysfunction caused by a dysregulated host response to infection AND
• Quick SOFA (qSOFA) with two or more of

• Respiratory rate ≥ 22/min
• Altered mentation (Glasgow Coma Scale score < 15)
• Systolic blood pressure ≤ 100mmHg AND
• Septic shock, defined as a clinical construct of sepsis with persisting hypotension requiring vasopressors to maintain MAP ≥65 mm Hg and having a serum lactate level >2 mmol/L despite adequate volume resuscitation AND
• Requiring infusion of noradrenalin 0.10 mcg/kg/min or more to maintain blood pressure AND
• Respiratory failure requiring intubation and mechanical ventilation

Exclusion criteria

• Documented refusal of blood transfusion OR
• Treatment with GPIIb/IIIa inhibitors < 24h from screening OR
• Withdrawal from active therapy OR
• Previously within 30 days included in an interventional trial OR
• Known IgA deficiency with documented antibodies against IgA OR
• Known hypersensitivity to OctaplasLG®: the active substance, any of the excipients (Sodium citrate dihydrate, Sodium dihydrogenphosphate dihydrate or Glycine) or residues from the manufacturing process (Tri (N-Butyl) Phosphate (TNBP) and Octoxynol (Triton X-100)) OR
• Known severe deficiencies of protein S OR
• Pregnancy (non-pregnancy confirmed by patient being postmenopausal or having a negative urine-hCG) OR
• Severe cirrhotic hepatic failure with expected need for treatment with terlipressin