Intravenous DNase I for the Treatment of Sepsis (IDEALSepsisI)

Exclusion Criteria17

• No consent/inability to obtain consent from a substitute decision-maker
• Have other forms of clinically apparent shock, including cardiogenic, obstructive (massive pulmonary embolism, cardiac tamponade, tension pneumothorax), hemorrhagic, neurogenic, or anaphylactic shock
• 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 malformation, cerebral aneurysm, or mass lesions of the central nervous system
• A history of congenital bleeding diatheses
• Gastrointestinal bleeding within five weeks before the study unless corrective surgery had been performed
• Trauma is considered to increase the risk of bleeding
• Presence of an epidural catheter
• Need for therapeutic anticoagulation
• Receiving DNase I by inhalation
• Terminal illness with a life expectancy of fewer than three months
• Pregnant and/or breastfeeding