Actively Recruiting
Intravenous DNase I for the Treatment of Sepsis (IDEALSepsisI)
Led by McMaster University · Updated on 2026-03-03
36
Participants Needed
1
Research Sites
193 weeks
Total Duration
On this page
Sponsors
M
McMaster University
Lead Sponsor
C
Canadian Institutes of Health Research (CIHR)
Collaborating Sponsor
AI-Summary
What this Trial Is About
Phase I dose-escalation safety and feasibility of IV DNase I in ICU septic patients.
CONDITIONS
Official Title
Intravenous DNase I for the Treatment of Sepsis (IDEALSepsisI)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age of 18 years or older
- Admitted to the ICU within the last 48 hours
- Suspected or confirmed infection as the reason for ICU admission
- A sepsis-related organ function score (SOFA) of 2 or higher above baseline
- Expected to remain in the ICU for 72 hours or more
You will not qualify if you...
- No consent or unable to obtain consent from a substitute decision-maker
- Presence of other types of shock such as cardiogenic, obstructive, hemorrhagic, neurogenic, or anaphylactic shock
- Significant risk of bleeding including recent surgery within 24 hours before enrollment or planned surgery in next 24 hours
- Evidence of active bleeding or history of severe head trauma requiring hospitalization
- Intracranial surgery or stroke within the past three months
- History of intracerebral arteriovenous malformation, cerebral aneurysm, or central nervous system mass lesions
- History of congenital bleeding disorders
- Gastrointestinal bleeding within five weeks before the study unless corrected by surgery
- Trauma increasing bleeding risk
- Presence of an epidural catheter
- Need for therapeutic anticoagulation
- Receiving DNase I by inhalation
- Terminal illness with life expectancy less than three months
- Pregnant or breastfeeding
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Hamilton Health Sciences
Hamilton, Ontario, Canada, L8L 0A4
Actively Recruiting
Research Team
A
Alison Fox-Robichaud, MD
CONTACT
P
Patricia Liaw, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
2
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