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Clinical Trials in Canada / NCT05453695
Recruiting Phase 1

Intravenous DNase I for the Treatment of Sepsis (IDEALSepsisI)

NCT05453695 · tracked via the Priya Life Science Canada tracker
Phase
Phase 1
Started
2023-01-17
Last updated
2026-03-03

Condition(s) studied

SepsisCritical Illness

Investigational drug(s) / intervention(s)

Intravenous DNase I

Intravenous DNase I: Dose-escalating intravenous infusion of DNase I

Study summary

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

Eligibility

Sex
ALL
Min age
18 Years
Max age
100 Years
Healthy volunteers
No
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

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Hamilton Health Sciences Hamilton Ontario Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05453695 on ClinicalTrials.gov ↗ ← All trials in Canada