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
This trial does not accept healthy volunteersQualifiers
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
Design model
Sequential
Treatments tested in this trial
Intravenous DNase I
DrugDose-escalating intravenous infusion of DNase I
Treatment groups
36 Participants
are divided into 2 treatment groupsGroup A: Intravenous DNase IExperimental treatment 1 intervention
Group B: ControlNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Number of patients recruited per month from the start of the study
Number of patients recruited per month
Time frame
up to 24 months2
Number of patients who completed the protocol
The ability to complete study infusion and blood collection as prescribed
Time frame
up to 7 daysSecondary outcomes
1
Sequential Organ Failure Assessment (SOFA) score
Quantitative variable: Maximal score of SOFA (Sequential Organ Failure Assessment) will be recorded; Value range 0-24 points * Delta SOFA score, defined as maximum versus minimum SOFA during ICU stay * Change in SOFA score within 48 hours
Time frame
Baseline to Day 102
Organ support free days
Increase of three or more days free from vasopressor therapy, invasive mechanical ventilation or renal replacement therapy.
Time frame
at Day 283
Duration of ICU admission
Number of days since admission to discharge from the ICU
Time frame
up to 9 months4
Time to Hospital discharge
Time elapsed between enrolment into the study (at admission), and discharge
Time frame
up to 90 daysSponsors and contacts
Click on the lead sponsor to view all of their trials.
McMaster University
Lead sponsor
Canadian Institutes of Health Research (CIHR)
Collaborator
Source ClinicalTrials.gov