Efficacy, Safety and Tolerability of Nangibotide in Patients With Septic Shock (ASTONISH)

This is an interventional treatment trial for Shock, Septic focused on measuring Septic Shock Read More

Inclusion Criteria:

1. Provide written informed consent
2. Age 18 to 85 years (inclusive)
3. Documented or suspected infection: lung, abdominal or urinary tract infection (UTI) in the elderly (≥65 years)
4. Organ dysfunction defined as acute change in total SOFA score ≥ 2 points
5. Refractory hypotension requiring vasopressors to maintain MAP ≥65mm Hg despite adequate volume resuscitation
6. Hyperlactatemia (blood lactate >2 mmol/L or 18 mg/dL).

Exclusion Criteria:

1. Previous episode of septic shock requiring vasopressor administration within current hospital stay
2. Underlying concurrent immunodepression with anti-CD52 alemtuzumab (Campath) or glucocorticoids >75 mg prednisone daily or equivalent for more than 7 days
3. Immunosuppressive therapy related to recent (<6 months) transplantation
4. Cancer chemotherapy (<3 months) implying an immunodepression
5. Known HIV infection with low CD4 cell count (<200) for at least 6 months
6. Known pregnancy (positive urine or serum pregnancy test)
7. Shock of any other cause, e.g. hypotension related to gastrointestinal bleeding
8. Ongoing documented or suspected endocarditis, history of prosthetic heart valves
9. Prolonged QT syndrome
10. End-stage neurological disease
11. End-stage cirrhosis (Child Pugh Class C)
12. Acute Physiology and Chronic Health Evaluation (APACHE II) score <15 or ≥ 34
13. Home oxygen therapy on a regular basis for > 6 h/day
14. Recent cardiopulmonary resuscitation (CPR) (within current hospital stay)
15. Body mass index (BMI) ≥ 40 kg/m2or weight ≥ 130 kg
16. Moribund patients
17. Decision to limit full care taken before obtaining informed consent
18. Participation in another interventional study in the 3 months prior to randomization