Micro and Macro Circulation in Sepsis

NCT05694455 | Completed FDA Device

• 1 other identifier: 22-0349
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Initiation and Duration Renal Replacement Therapy

  Renal Replacement Therapy will be monitored while hospitalized for Sepsis/Septic Shock for initiation and days receiving Renal replacement will be counted.

  90 day

Secondary Outcomes (2)

• Rate of Inpatient Mortality

  90 day

• Rate of 90 day survival

  90 day

Study Arms (2)

Septic Patient Interventions

OTHER

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

Diagnostic Test: Starling Stroke Volume (Starling SV)- Passive Leg Raise; Diagnostic Test: Microscan Sublingual Microscopy; Diagnostic Test: Venous Excess Ultrasound Scoring (VExUS); Other: Urine Collection

Control Patient Interventions

OTHER

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

Diagnostic Test: Starling Stroke Volume (Starling SV)- Passive Leg Raise; Other: Urine Collection

Interventions

Starling Stroke Volume (Starling SV)- Passive Leg Raise DIAGNOSTIC_TEST

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

Also known as: Baxter Starling Stroke Volume (SV)

Control Patient Interventions; Septic Patient Interventions

Microscan Sublingual Microscopy DIAGNOSTIC_TEST

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.

Also known as: Microvision Sublingual Microscopy

Septic Patient Interventions

Venous Excess Ultrasound Scoring (VExUS) DIAGNOSTIC_TEST

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

Septic Patient Interventions

Urine Collection OTHER

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.

Control Patient Interventions; Septic Patient Interventions

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Septic Patient Cohort:
• Greater than or equal to 18 years of age
• Diagnosed with sepsis or septic shock
• Require admission to the Hospital
• Control Cohort:
• Greater than or equal to 18 years of age
• Undergoing elective surgery requiring intubation and general anesthesia

You may not qualify if:

• Patients with any of the following characteristics will be excluded
• Less than 18 years old
• Chronic Kidney disease on dialysis
• Currently pregnant
• Incarcerated persons
• Control Cohort:
• Less than 18 years old
• History of Chronic Kidney disease on dialysis, uncontrolled diabetes, cirrhosis, heart failure, or nephritic or nephrotic syndromes.
• Currently pregnant
• Incarcerated persons

Sponsors & Collaborators

• Denver Health and Hospital Authority: lead
• National Institutes of Health (NIH): collaborator

Study Sites (1)

Denver Health Medical Center

Denver, Colorado, 80204, United States

Location

MeSH Terms

Conditions

Sepsis; Shock, Septic

Interventions

Urine Specimen Collection

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Shock

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Pulmonary Critical Care

Model Details: Patients diagnosed with septic shock in the emergency department admitted to the hospital will be enrolled within 4 hours of the emergency physician's decision to admit the patient to the hospital. On enrollment, On enrollment and at hours 10-14, 22-26, and 44-48, the research team will assess micro hemodynamic incoherence and Macro hemodynamic incoherence as well as the total amount of IV fluids and vasoactive medications administered, demographics, Charlson morbidity scale and Sofa score. Healthy controls will have sublingual microscopy and urine collection performed at time of intubation for elective procedure.

Study Record Dates

• First Submitted: January 5, 2023
• First Posted: January 23, 2023
• Study Start: July 1, 2022
• Primary Completion: May 31, 2025
• Study Completion: May 31, 2025
• Last Updated: December 5, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)