Intravenous DNase I for the Treatment of Sepsis (IDEALSepsisI)
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-100
SponsorMcMaster University
About this trial
Phase I dose-escalation safety and feasibility of IV DNase I in ICU septic patients.
Eligibility criteria
Qualifiers
Age of ≥18 years
Admitted to the ICU in the last 48 hours
Suspected or proven infection as the admitting diagnosis
A sequential (sepsis) organ function assessment (SOFA) score of ≥2 above baseline
Disqualifiers
No consent/inability to obtain consent from a substitute decision-maker
Have other forms of clinically apparent shock, including cardiogenic, obstructive (massive pulmonary embolism, cardiac tamponade, tension pneumothorax), hemorrhagic, neurogenic, or anaphylactic shock
Surgery requiring general or spinal anesthesia within 24 hours before enrolment
The potential need for surgery in the next 24 hours
Trial design
Treatments tested in this trial
- Intravenous DNase I
Treatment groups
36 Participants
are divided into 2 treatment groupsSponsors and collaborators
McMaster University
Lead sponsor
Canadian Institutes of Health Research (CIHR)
Collaborator
Source ClinicalTrials.gov