Hyperdynamic Left Ventricular Ejection Fraction as a Predictor of Mortality in Intensive Care Unit Patients With Septic Shock

NCT06993948 | Completed

• 1 other identifier: MD 260/2022
• Study Type: observational
• Target: 235
• Locations: 1 country
• Sites: 1

Brief Summary

The study aimed to evaluate the cause and prognosis of hyperdynamic left ventricular ejection fraction in critically ill patients with sepsis.

Conditions

Hyperdynamic; Left Ventricular Ejection Fraction; Mortality; Intensive Care Unit; Septic Shock

Outcome Measures

Primary Outcomes (1)

• Intensive care unit mortality

  Such patients are admitted to the intensive care unit (ICU), where a definitive diagnosis of sepsis is established using the Sequential Organ Failure Assessment (SOFA) score. This validated scoring system is widely recognized for its ability to predict mortality by evaluating dysfunction across six critical organ systems: respiratory, cardiovascular, hepatic, coagulation, renal, and neurological. The SOFA score is initially calculated upon ICU admission and is subsequently updated every 24 hours, using the most abnormal clinical or laboratory values recorded during the preceding day.

  28 days post-procedure

Secondary Outcomes (2)

• Discharge against medical advice

  28 days post-procedure

• Incidence of patients who choose to leave the intensive care unit

  28 days post-procedure

Study Arms (1)

Septic shock group

Patients underwent left ventricular ejection fraction (LVEF) assessment using two-dimensional echocardiography using visual estimation.

Device: Transthoracic echocardiography

Interventions

Transthoracic echocardiography DEVICE

Transthoracic echocardiography (TTE) was carried out. The assessment of left ventricular ejection fraction (LVEF) relied primarily on two-dimensional echocardiography using visual estimation.

Septic shock group

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

This prospective observational study involved 235 patients admitted to the Intensive Care Unit (ICU) from August 2022 to July 2023.

You may qualify if:

• Age over 18 years.
• Both sexes.
• Patients who were diagnosed with septic shock.

You may not qualify if:

• \- Patients with previously documented abnormal transthoracic echocardiography (TTE) findings, such as severe valvular disease, poor echocardiographic windows, patients admitted to cardiothoracic intensive care unit (ICU), and those not meeting sepsis criteria.

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Ain Shams University

Cairo, 11591, Egypt

Location

Related Publications (1)

• Hedia DSM, Mahmoud HO, AbdelFattah AM, AbdelSalam EH, Mahmoud OS. Hyperdynamic left ventricular ejection fraction as a predictor of mortality in intensive care unit patients with septic shock. Heart Lung. 2025 Nov 29;76:106-112. doi: 10.1016/j.hrtlng.2025.11.015. Online ahead of print.

  PMID: 41319356 DERIVED

MeSH Terms

Conditions

Shock, Septic

Interventions

Echocardiography

Condition Hierarchy (Ancestors)

Sepsis; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Shock

Intervention Hierarchy (Ancestors)

Cardiac Imaging Techniques; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Ultrasonography; Heart Function Tests; Diagnostic Techniques, Cardiovascular

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Lecturer of Anesthesia, Intensive Care and Pain Management Department, Faculty of Medicine, Ain Shams University, Cairo, Egypt.

Study Record Dates

• First Submitted: May 20, 2025
• First Posted: May 29, 2025
• Study Start: August 1, 2022
• Primary Completion: July 1, 2023
• Study Completion: July 1, 2023
• Last Updated: May 29, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: After the end of study for one year.
• Access Criteria: The data will be available upon a reasonable request from the corresponding author.

Locations

EG (1)