Intravenous DNase I for the Treatment of Sepsis (IDEALSepsisI)

• Status: Not yet recruiting
• Trial end date: 2025-09-01
• Target enrollment: 0
• Participant gender: All

Summary

Phase I dose-escalation safety and feasibility of IV DNase I in ICU septic patients.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: McMaster University
• Collaborator: Canadian Institutes of Health Research (CIHR)

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