Sepsis Clinical Trial
Official title:
Evaluation of Mitral Annulus Systolic Plane Excursion (MAPSE) in Emergency Department Patients With Sepsis
| NCT number | NCT05634733 |
| Other study ID # | HP-00102983 |
| Secondary ID | |
| Status | Recruiting |
| Phase | |
| First received | |
| Last updated | |
| Start date | April 1, 2023 |
| Est. completion date | December 1, 2025 |
Patients with bloodstream infections (sepsis) have been found in prior studies to have infection-related heart dysfunction, even if they did not have preexisting heart problems. Factors related to the infection may cause the heart to not pump as well as it should, causing critical illness in the form of low blood pressure (shock) and heart failure. Ultrasound is frequently used in the emergency department to evaluate why a patient might have low blood pressure. Part of that evaluation may include obtaining ultrasound images and making measurements about how well or poorly the heart is pumping. The investigators will evaluate a certain measurement that relates to cardiac function, determine how it changes in patients before and after they are treated for septic shock. This will involve placing an ultrasound probe on the patient's chest, measuring the upward and downward movement of the mitral valve, the mitral annulus systolic plane excursion (MAPSE), and comparing the measurements before and after treatment is started. The investigators are attempting to determine if this measurement improves before and after treatment.
| Status | Recruiting |
| Enrollment | 50 |
| Est. completion date | December 1, 2025 |
| Est. primary completion date | April 1, 2025 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | Inclusion Criteria: - Diagnosis of Sepsis or Septic Shock Exclusion Criteria: - Age equal to or less than 17 - patient in the emergency department - Unable to perform POCUS exam due to medical necessity - Patients without sepsis - unable to obtain consent or have a legal representative consent |
| Country | Name | City | State |
|---|---|---|---|
| United States | University of Maryland Medical Center | Baltimore | Maryland |
| Lead Sponsor | Collaborator |
|---|---|
| University of Maryland, Baltimore |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Change in MAPSE measurement | Does the MAPSE change after treatment of MAPSE | 1 hour after treatment initiation |
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