Intravenous DNase I for the Treatment of Sepsis (IDEALSepsisI)
Trial Parameters
Brief Summary
Phase I dose-escalation safety and feasibility of IV DNase I in ICU septic patients.
Eligibility Criteria
Inclusion Criteria: 1. Age of ≥18 years 2. Admitted to the ICU in the last 48 hours 3. Suspected or proven infection as the admitting diagnosis 4. A sequential (sepsis) organ function assessment (SOFA) score of ≥2 above baseline 5. Expected to remain in the ICU for ≥ 72 hours Exclusion Criteria: 1. No consent/inability to obtain consent from a substitute decision-maker 2. Have other forms of clinically apparent shock, including cardiogenic, obstructive (massive pulmonary embolism, cardiac tamponade, tension pneumothorax), hemorrhagic, neurogenic, or anaphylactic shock 3. Have a significant risk of bleeding as evidenced by one of the following: * Surgery requiring general or spinal anesthesia within 24 hours before enrolment * The potential need for surgery in the next 24 hours * Evidence of active bleeding * A history of severe head trauma requiring hospitalization * Intracranial surgery, or stroke within three months before the study * Any history of intracerebral arteriovenous malfor