Actively Recruiting

Phase 1
Age: 18Years - 100Years
All Genders
NCT05453695

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

Age: 18Years - 100Years
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Hamilton Health Sciences

Hamilton, Ontario, Canada, L8L 0A4

Actively Recruiting

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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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