Recruiting

Cardiac Function

Sponsor:

University of Maryland, Baltimore

Code:

NCT05634733

Conditions

Sepsis

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Treatment of Sepsis

Study Details

Brief summary:

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.

Conditions

Sepsis

Study ID

NCT05634733

Start date

Apr 1, 2023

Status verified date

Jun, 2025

Completion date

Dec 1, 2030

Anticipated

Primary completion date

Apr 1, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

50 participants

Anticipated

Interventions and Outcome Measures

Arms

Patients with Sepsis

These are patients who present to the emergency department with sepsis. They will have a MAPSE at the time of enrollment and then after initial treatment.

Interventions

Treatment of Sepsis

Patients will have standard care of sepsis

Primary outcome measure

  • Change in MAPSE measurement [ Time Frame: 1 hour after treatment initiation ]

Central Contacts and Locations

Central contacts

Locations

University of Maryland Medical Center

Recruiting

Baltimore, Maryland, United States, 21201

More Information

Sponsor

University of Maryland, Baltimore

Last update posted

Jun 19, 2025

Last verified

Jun, 2025

Keywords

  • POCUS
  • Emergency Department
  • echocardiography

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Maryland, Baltimore on 2025-06-19.