Circulation Evaluation Techniques for Sepsis

(DAISY Trial)

Overseen By Terra Hiller, MSN, RN

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Denver Health and Hospital Authority

Disqualifiers: Chronic kidney disease, Uncontrolled diabetes, Cirrhosis, Heart failure, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

150 Participants Needed

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.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

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.

During hospitalization

Follow-up

Participants are monitored for safety and effectiveness after treatment, including monitoring of Renal Replacement Therapy and survival rates.

90 days

Treatment Details

Interventions

• Microscan Sublingual Microscopy
• Starling SV- Passive Leg Raise
• Urine Collection
• Vexus Ultrasound Scoring

Trial Overview 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.

Participant Groups

Group I: Septic Patient Interventions Experimental Treatment 4 Interventions

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

Group II: Control Patient Interventions Experimental Treatment 2 Interventions

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

Who Is Running the Clinical Trial?

Denver Health and Hospital Authority

Lead Sponsor

Trials

106

Recruited

403,000+

National Institutes of Health (NIH)

Collaborator

Trials

2,896

Recruited

8,053,000+