Intravenous DNase I for the Treatment of Sepsis (IDEALSepsisI)

About this trial

Last updated 3 months ago

Study ID

IDEALSepsisI

Status

Recruiting

Type

Interventional

Phase

Phase 1

Placebo

Accepting

18 to 100 Years

All Sexes

Trial Timing

Started 3 years ago

What is this trial about?

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

What are the participation requirements?

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