Using DNase I to treat sepsis in ICU patients
Intravenous DNase I for the Treatment of Sepsis: A Phase I Safety and Feasibility Study in ICU Patients
This study tests if a new treatment called DNase I can help improve recovery for ICU patients with sepsis by breaking down harmful substances in their bodies.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 36 (estimated) |
| Ages | 18 Years to 100 Years |
| Sex | All |
| Sponsor | McMaster University Academic / other |
| Locations | 1 site (Hamilton, Ontario) |
| Trial ID | NCT05453695 on ClinicalTrials.gov |
What this trial studies
This Phase I trial investigates the safety and feasibility of intravenous DNase I in patients with sepsis admitted to the ICU. The study aims to determine the maximum tolerated dose of DNase I while evaluating its effects on organ dysfunction, ICU length of stay, and mortality rates. By dismantling neutrophil extracellular traps (NETs) that contribute to organ damage, DNase I may improve patient outcomes in critically ill septic patients. The trial will also collect samples for future research on coagulation and immune function in sepsis.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older who have been admitted to the ICU within the last 48 hours with suspected or proven infections and a SOFA score of 2 or higher.
Not a fit: Patients with other forms of shock or significant bleeding risks may not benefit from this treatment.
Why it matters
Potential benefit: If successful, this treatment could significantly improve recovery and survival rates for patients suffering from sepsis.
How similar studies have performed: While this approach is novel, previous animal studies have shown promise for DNase I in treating sepsis.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Hamilton, Ontario
- Hamilton Health Sciences — Hamilton, Ontario, Canada (Recruiting)
Study contacts
- Study coordinator: Alison Fox-Robichaud, MD
- Email: afoxrob@mcmaster.ca
- Phone: 905 521 2100
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.