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Completed

NCT Number: NCT06993948

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

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Ain Shams University

Cairo, 11591, Egypt

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. Intensive care unit mortality

    Time frame: 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 outcomes

  1. Discharge against medical advice

    Time frame: 28 days post-procedure

    Discharge against medical advice was recorded.

  2. Incidence of patients who choose to leave the intensive care unit

    Time frame: 28 days post-procedure

    Incidence of patients who choose to leave the intensive care unit against medical advice.

Sponsors and collaborators

Lead sponsor

Ain Shams University

Other

Registry information

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
May 29, 2025
Registry last updated
May 29, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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