RecruitingPhase 1NCT05453695

Intravenous DNase I for the Treatment of Sepsis (IDEALSepsisI)

Intravenous DNase I for the Treatment of Sepsis: A Phase I Safety and Feasibility Study in ICU Patients

Sponsor

McMaster University

Enrollment

36 participants

Start Date

Jan 17, 2023

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 YearsMax Age: 100 Years

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
Expected to remain in the ICU for ≥ 72 hours

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
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
Receiving DNase I by inhalation
Terminal illness with a life expectancy of fewer than three months
Pregnant and/or breastfeeding