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NCT05694455
Micro and Macro Circulation in Sepsis
Conditions: Sepsis, Septic Shock
Sex: All
Ages: 18 Years – 99 Years
Healthy volunteers: 1
Phase: NA
Enrollment: 150
Sponsor: Denver Health and Hospital Authority
Location: United States
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 MiH and the perfused boundary region (PBR, an visual proxy for eGC thickness) using HVM, and a validated circulating biomarker of eGC integrity.
Eligibility Criteria
Inclusion Criteria:Septic Patient Cohort:Greater than or equal to 18 years of ageDiagnosed with sepsis or septic shockRequire admission to the HospitalControl Cohort:Greater than or equal to 18 years of ageUndergoing elective surgery requiring intubation and general anesthesiaExclusion Criteria:Patients with any of the following characteristics will be excludedLess than 18 years oldChronic Kidney disease on dialysisCurrently pregnantIncarcerated personsControl Cohort:Less than 18 years oldHistory of Chronic Kidney disease on dialysis, uncontrolled diabetes, cirrhosis, heart failure, or nephritic or nephrotic syndromes.Currently pregnantIncarcerated persons
Source: ClinicalTrials.gov (NCT05694455). StuddyBuddy aggregates publicly available trial information.