HyperdynamicNCT06993948
Hyperdynamic Left Ventricular Ejection Fraction as a Predictor of Mortality in Intensive Care Unit Patients With Septic Shock
An observational study of Hyperdynamic and Left Ventricular Ejection Fraction, run by Ain Shams University at 1 site in Egypt.
Trial summary
The study aimed to evaluate the cause and prognosis of hyperdynamic left ventricular ejection fraction in critically ill patients with sepsis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hyperdynamic, Left Ventricular Ejection Fraction, Mortality
- What is being tested?
- Transthoracic echocardiography
- Type of treatment
- Medical device
- How many people
- 235 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Aug 2022to 1 Jul 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: This prospective observational study involved 235 patients admitted to the Intensive Care Unit (ICU) from August 2022 to July 2023.
Who may be able to join
- Age over 18 years.
- Both sexes.
- Patients who were diagnosed with septic shock.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
The study aimed to evaluate the cause and prognosis of hyperdynamic left ventricular ejection fraction in critically ill patients with sepsis.
Read the 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).
- Conditions
- Hyperdynamic, Left Ventricular Ejection Fraction, Mortality, Intensive Care Unit, Septic Shock
- Being tested
- Transthoracic echocardiography
- Medical subject headings
- Shock, Septic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transthoracic echocardiographyDevice
Transthoracic echocardiography (TTE) was carried out. The assessment of left ventricular ejection fraction (LVEF) relied primarily on two-dimensional echocardiography using visual estimation.
| Study group | Role | What they receive |
|---|---|---|
| Septic shock group | Patients underwent left ventricular ejection fraction (LVEF) assessment using two-dimensional echocardiography using visual estimation. Receives: Device: Transthoracic echocardiography |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 28 days post-procedure
Secondary outcomes (2)
Discharge against medical advice
Discharge against medical advice was recorded.
Measured: 28 days post-procedure
Incidence of patients who choose to leave the intensive care unit
Incidence of patients who choose to leave the intensive care unit against medical advice.
Measured: 28 days post-procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2025
- Study start1 Aug 2022
- Primary completion1 Jul 2023
- Study completion1 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HyperdynamicStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 235 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Doaa Saeed Mohamed Hedia, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06993948
- Sponsor's protocol ID
- MD 260/2022
- Status last verified
- May 2025
- First submitted
- 20 May 2025
- Last updated
- 29 May 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
Publications
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. 2026 Mar-Apr;76:106-112. doi: 10.1016/j.hrtlng.2025.11.015. Epub 2025 Nov 29.
PubMed 41319356
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hyperdynamic Left Ventricular Ejection Fraction as a Predictor of Mortality in Intensive Care Unit Patients With Septic Shock
- ClinicalTrials.gov ID
- NCT06993948
- Acronym / sponsor ID
- MD 260/2022
- Conditions
- Hyperdynamic, Left Ventricular Ejection Fraction, Mortality, Intensive Care Unit, Septic Shock
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 235 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 1 Aug 2022 (actual)
- Primary completion
- 1 Jul 2023 (actual)
- Study completion
- 1 Jul 2023 (actual)
- First posted
- 29 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Septic shock group | – | Device: Transthoracic echocardiographyPatients underwent left ventricular ejection fraction (LVEF) assessment using two-dimensional echocardiography using visual estimation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This prospective observational study involved 235 patients admitted to the Intensive Care Unit (ICU) from August 2022 to July 2023.
Key inclusion criteria (3 listed)
- Age over 18 years.
- Both sexes.
- Patients who were diagnosed with septic shock.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transthoracic echocardiographyTransthoracic echocardiography (TTE) was carried out. The assessment of left ventricular ejection fraction (LVEF) relied primarily on two-dimensional echocardiography using visual estimation. | Device | Septic shock group |
Primary outcome
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.
2 secondary outcomes
Discharge against medical advice
Time frame: 28 days post-procedure
Incidence of patients who choose to leave the intensive care unit
Time frame: 28 days post-procedure
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2025.
- Derived from this study: PubMed 41319356Hedia 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. 2026 Mar-Apr;76:106-112. doi: 10.1016/j.hrtlng.2025.11.015. Epub 2025 Nov 29.
- Individual participant dataSharing planned: Yes. The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hyperdynamic and Left Ventricular Ejection Fraction, run by Ain Shams University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intensive care unit mortality (time frame: 28 days post-procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06993948, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 May 2025.