Using DNase I to treat sepsis in ICU patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Hamilton Health Sciences
  Hamilton, Ontario, Canada Recruiting

Study contacts

• Study coordinator: Alison Fox-Robichaud, MD
• Email: afoxrob@mcmaster.ca
• Phone: 905 521 2100

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.