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

Completed

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

• Registration Number: NCT06993948
• Lead Sponsor: Ain Shams University

Brief Summary

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

Detailed Description

Cardiovascular dysfunction is increasingly being recognized as a significant complication in sepsis, affecting patient outcomes.

Among the key parameters used to evaluate cardiac performance is the left ventricular ejection fraction (LVEF), typically assessed via transthoracic echocardiography (TTE).

LVEF has been extensively studied; most investigations into preserved ejection fraction tend to group all values ≥50% together, thereby overlooking the potential clinical implications of LVEF ≥70%, often referred to as hyperdynamic LVEF (HDLVEF).

Study Timeline

• Study Start: 2022-08-01
• Primary Completion: 2023-07-01
• Study Completion: 2023-07-01
• Status Verified: 2025-05
• Study First Submitted: 2025-05-20
• Study First Submitted QC: 2025-05-20
• Last Update Submitted: 2025-05-20
• Study First Posted: 2025-05-29
• Last Update Posted: 2025-05-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 235

Inclusion Criteria

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

Exclusion Criteria

• 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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Intensive care unit mortality	28 days post-procedure	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.

Secondary Outcome Measures

Name	Time	Method
Discharge against medical advice	28 days post-procedure	Discharge against medical advice was recorded.
Incidence of patients who choose to leave the intensive care unit	28 days post-procedure	Incidence of patients who choose to leave the intensive care unit against medical advice.

Trial Locations

Locations (1)

Ain Shams University; 🇪🇬 Cairo, Egypt