Micro and Macro Circulation in Sepsis

Summary

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.

Conditions

• Sepsis
• Septic Shock

Interventions

DIAGNOSTIC_TEST

Starling Stroke Volume (Starling SV)- Passive Leg Raise

All septic patients will have a passive leg raise performed with the assistance of an Starling SV device to look at Stroke Volume change. This will be performed at admission and 4 hours after admission. This intervention will not be performed on healthy controls

DIAGNOSTIC_TEST

Microscan Sublingual Microscopy

All septic patients will have sublingual microscopic images performed at admission, 8-16 hours, 48 hours and 72 hours. Control patients will have a sublingual microscope imaging performed after intubation for the elective procedure. This is a process of a 2cm probe tip gently placed on patients' mouth and 3 different images of 5-8 seconds are recorded.

DIAGNOSTIC_TEST

Venous Excess Ultrasound Scoring (VExUS)

All septic Patients will have this performed on all patients at admission, 8-16 hours, 48 hours and 72 hours. Ultrasound images and blood flow waves will be collected of the Inferior Vena Cava diameter, hepatic vein, portal vein, renal veins and scored using the Venous Excess Ultrasound (VExUS scale). Healthy controls will not have ultrasound performed

OTHER

Urine Collection

The urine assay is collected passively from the patient will be ran through a Dimethylmethylene blue (DMMB assay)- could provide future beneficial information to resuscitation efforts. This will be performed on all septic patients at admission, 8-16 hours, 48 hours and 72 hours. Urine will be collected on healthy controls at time of intubation for elective procedure.

Sponsors & Collaborators

• National Institutes of Health (NIH)

  collaborator NIH

• Denver Health and Hospital Authority

  lead OTHER

Study Design

Allocation

NON_RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Max Age

99 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2022-07-01

Primary Completion

2025-05-31

Completion

2025-05-31

FDA Device

Yes

Countries

• United States

Study Locations