Assessing blood circulation in sepsis patients
Clinical Utility of Longitudinal Measurement of Hemodynamic Incoherence and Endothelial
This study is testing if a new tool can help doctors understand blood flow issues in patients with sepsis and see how it affects their recovery.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 150 (estimated) |
| Ages | 18 Years to 99 Years |
| Sex | All |
| Sponsor | Denver Health and Hospital Authority Academic / other |
| Locations | 1 site (Denver, Colorado) |
| Trial ID | NCT05694455 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the prognostic role of Handheld Vital Microscopy (HVM) in patients with sepsis and septic shock, focusing on the breakdown of endothelial glycocalyx (eGC) and its relationship with hemodynamic incoherence (HI). By serially measuring microhemodynamics and macro hemodynamics, the study seeks to uncover mechanisms linking eGC integrity to patient outcomes. The research is particularly relevant given the increased incidence of sepsis during the COVID-19 pandemic, highlighting the need for better prognostic indicators. The study will involve both septic patients and a control group undergoing elective surgery.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older diagnosed with sepsis or septic shock requiring hospital admission.
Not a fit: Patients under 18, those with chronic kidney disease on dialysis, or currently pregnant may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved prognostic tools for sepsis, enhancing patient management and outcomes.
How similar studies have performed: While the specific approach of using HVM in this context is novel, similar studies have indicated the importance of microhemodynamic measures in predicting outcomes in sepsis.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: Septic Patient Cohort: 1. Greater than or equal to 18 years of age 2. Diagnosed with sepsis or septic shock 3. Require admission to the Hospital Control Cohort: 1. Greater than or equal to 18 years of age 2. Undergoing elective surgery requiring intubation and general anesthesia Exclusion Criteria: Patients with any of the following characteristics will be excluded 1. Less than 18 years old 2. Chronic Kidney disease on dialysis 3. Currently pregnant 4. Incarcerated persons Control Cohort: 1. Less than 18 years old 2. History of Chronic Kidney disease on dialysis, uncontrolled diabetes, cirrhosis, heart failure, or nephritic or nephrotic syndromes. 3. Currently pregnant 4. Incarcerated persons
Where this trial is running
Denver, Colorado
- Denver Health Medical Center — Denver, Colorado, United States (Recruiting)
Study contacts
- Study coordinator: August Longino, MD
- Email: August.longino@cuanschutz.edu
- Phone: 801-903-3258
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.