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

Efficacy and Safety of OctaplasLG® Administration vs. Crystalloids (Standard) in Patients With Septic Shock - a Randomized, Controlled, Open-label Investigator-initiated Pilot Trial

Efficacy and safety of OctaplasLG® administration vs. crystalloids (standard) in patients with septic shock - a randomized, controlled, open-label investigator-initiated pilot 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:

1. Adult intensive care patients (age ≥ 18 years) AND

2. Sepsis, defined as life-threatening organ dysfunction caused by a dysregulated host response to infection AND

3. Quick SOFA (qSOFA) with two or more of

   1. Respiratory rate ≥ 22/min
   2. Altered mentation (Glasgow Coma Scale score < 15)
   3. Systolic blood pressure ≤ 100mmHg AND

4. 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

5. Requiring infusion of noradrenalin 0.10 mcg/kg/min or more to maintain blood pressure AND

6. Respiratory failure requiring intubation and mechanical ventilation

Exclusion Criteria:

1. Documented refusal of blood transfusion OR
2. Treatment with GPIIb/IIIa inhibitors < 24h from screening OR
3. Withdrawal from active therapy OR
4. Previously within 30 days included in an interventional trial OR
5. Known IgA deficiency with documented antibodies against IgA OR
6. 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
7. Known severe deficiencies of protein S OR
8. Pregnancy (non-pregnancy confirmed by patient being postmenopausal or having a negative urine-hCG) OR
9. Severe cirrhotic hepatic failure with expected need for treatment with terlipressin