Change in MAPSE During Treatment of Sepsis

NCT05634733 | Recruiting DMC

• 1 other identifier: HP-00102983
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

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

Keywords

POCUS; Emergency Department; echocardiography

Outcome Measures

Primary Outcomes (1)

• Change in MAPSE measurement

  Does the MAPSE change after treatment of MAPSE

  1 hour after treatment initiation

Study Arms (1)

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.

Other: Treatment of Sepsis

Interventions

Treatment of Sepsis OTHER

Patients will have standard care of sepsis

Patients with Sepsis

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

adult emergency department patients who present with sepsis

You may qualify if:

• Diagnosis of Sepsis or Septic Shock

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Maryland, Baltimore: lead

Study Sites (1)

University of Maryland Medical Center

Baltimore, Maryland, 21201, United States

RECRUITING

MeSH Terms

Conditions

Sepsis; Emergencies

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Alexis Salerno, MD

CONTACT

(667) 214-2208; alexis.salerno@som.umaryland.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Emergency Medicine

Study Record Dates

• First Submitted: November 22, 2022
• First Posted: December 2, 2022
• Study Start: April 1, 2023
• Primary Completion (Estimated): April 1, 2030
• Study Completion (Estimated): December 1, 2030
• Last Updated: June 19, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)