Change in MAPSE During Treatment of Sepsis

June 16, 2025 updated by: Alexis Salerno, University of Maryland, Baltimore

Evaluation of Mitral Annulus Systolic Plane Excursion (MAPSE) in Emergency Department Patients With Sepsis

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Maryland
      • Baltimore, Maryland, United States, 21201
        • Recruiting
        • University of Maryland Medical Center
        • Contact:
          • Alexis Salerno, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

adult emergency department patients who present with sepsis

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
Patients will have standard care of sepsis

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in MAPSE measurement
Time Frame: 1 hour after treatment initiation
Does the MAPSE change after treatment of MAPSE
1 hour after treatment initiation

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
ICU length of stay
Time Frame: until completion, anticipated 2 weeks.
In patients with a change in MAPSE measurement, do they have a difference in ICU length of stay.
until completion, anticipated 2 weeks.
Mortality Rate
Time Frame: until completion, anticipated 1 month.
In patients with a change in MAPSE measurement, do they have a different mortality rate?
until completion, anticipated 1 month.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Maryland, Baltimore

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2023

Primary Completion (Estimated)

April 1, 2030

Study Completion (Estimated)

December 1, 2030

Study Registration Dates

First Submitted

November 22, 2022

First Submitted That Met QC Criteria

November 22, 2022

First Posted (Actual)

December 2, 2022

Study Record Updates

Last Update Posted (Actual)

June 19, 2025

Last Update Submitted That Met QC Criteria

June 16, 2025

Last Verified

June 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HP-00102983

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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