Intravenous DNase I for the Treatment of Sepsis (IDEALSepsisI)

Participation Requirements

• Sex:

  ALL

• Eligible Ages:

  18 and up

Participation 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 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
4. Receiving DNase I by inhalation
5. Terminal illness with a life expectancy of fewer than three months
6. Pregnant and/or breastfeeding