Circulation Evaluation Techniques for Sepsis
(DAISY Trial)
Trial Summary
What is the purpose of this trial?
Purpose: To assess the prognostic role of Handheld Vital Microscopy (HVM) and evaluate levels of endothelial glycocalyx (eGC) breakdown in patients demonstrating Hemodynamic Incoherence (HI), to elucidate a mechanistic link between the eGC and HI in order to inform prognostic enrichment of future resuscitation trials. We will serially evaluate microhemodynamics (MiH) and macro hemodynamics (maH) and the perfused boundary region (PBR, an visual proxy for eGC thickness) using HVM, and a validated circulating biomarker of eGC integrity.
Eligibility Criteria
This trial is for adults diagnosed with sepsis or septic shock who need to be admitted to the hospital. It also includes a control group of adults undergoing elective surgery that requires intubation and general anesthesia.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Intervention
Control patients will have urine collection and sublingual microscopy performed when intubated. Septic patients will have urine collection, Passive Leg Raise, Ultrasound, and sublingual microscopy performed.
Follow-up
Participants are monitored for safety and effectiveness after treatment, including monitoring of Renal Replacement Therapy and survival rates.
Treatment Details
Interventions
- Microscan Sublingual Microscopy
- Starling SV- Passive Leg Raise
- Urine Collection
- Vexus Ultrasound Scoring
Find a Clinic Near You
Who Is Running the Clinical Trial?
Denver Health and Hospital Authority
Lead Sponsor
National Institutes of Health (NIH)
Collaborator