Circulation Evaluation Techniques for Sepsis
(DAISY Trial)

Recruiting in Palo Alto (17 mi)

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Denver Health and Hospital Authority

No Placebo Group

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

I am 18 or older, diagnosed with sepsis or septic shock, and need hospital admission.

I am 18 or older and will have surgery under general anesthesia.

Exclusion Criteria

Currently pregnant

Incarcerated persons

I am under 18 years old.

+2 more

Participant Groups

The study aims to understand how well handheld vital microscopy can predict outcomes in patients by looking at tiny blood vessels under the tongue and measuring substances in the urine that indicate blood vessel health.

2Treatment groups

Experimental Treatment

Group I: Septic Patient InterventionsExperimental Treatment4 Interventions

Septic Patients will have all interventions performed: Urine collection, Passive Leg Raise, Ultrasound and sublingual microscopy

Group II: Control Patient InterventionsExperimental Treatment2 Interventions

Control patients will have urine collection and sublingual microscopy performed when intubated