Septic ShockNCT06008067
The Prognostic Role of Tricuspid Annular Plane Systolic Excursion in Critically Ill Patients With Septic Shock
An observational study of Septic Shock, run by Alexandria University at 1 site in Egypt.
Trial summary
The aim of this study is to evaluate the possible prognostic performance of RV dysfunction, as assessed by TAPSE, in non-cardiac patients with septic shock. Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Septic Shock
- What is being tested?
- tricuspid annular plane systolic excursion (TAPSE)
- Type of treatment
- Surgery or procedure
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Apr 2023to 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 to 64 years
- All sexes
- Adult
Study population: Adult patients (18 - 64 years old) with septic shock after admission according to 2016 consensus definition (Sepsis-3).
Who may be able to join
- Adult patients (18 - 64 years old) with septic shock after admission according to 2016 consensus definition (Sepsis-3).
Who cannot join
- Pregnant females
- Trauma
- Documented coronary heart disease
- History of myocardial infarction
- Myocarditis
- Thrombo-embolic pulmonary disease
Show all 11Show fewer
- Valvular heart disease
- Corpulmonale
- Arrhythmia
- Known left ventricular ejection fraction < 40%
- Poor echocardiographic window
Trial locations and contacts
1 site in 1 country.
About this study
The aim of this study is to evaluate the possible prognostic performance of RV dysfunction, as assessed by TAPSE, in non-cardiac patients with septic shock.
Read the detailed description
The objective is to investigate the prognostic performance of right ventricular dysfunction, as assessed by tricuspid annular plane systolic excursion (TAPSE), in non-cardiac patients with septic shock.
- Conditions
- Septic Shock
- Being tested
- tricuspid annular plane systolic excursion (TAPSE)
- Keywords
- Critical Care, Septic Shock, Echocardiography, RV dysfunction
- Medical subject headings
- Shock, Septic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tricuspid annular plane systolic excursion (TAPSE)Radiation
Echocardiography
| Study group | Role | What they receive |
|---|---|---|
| Survivors | Patients who survived after day 28. Receives: Radiation: tricuspid annular plane systolic excursion (TAPSE) | |
| Non-survivors | Patients who died at or before day 28. Receives: Radiation: tricuspid annular plane systolic excursion (TAPSE) |
What is being measured
The primary outcome is the main question the study is designed to answer.
28-day mortality
Mortality rate after at day 28.
Measured: Day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2023
- Study start1 Apr 2023
- 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 Septic ShockStudies of the same condition, open and under way.
- More trials run by Alexandria UniversityThe sponsor's other registered studies.
- 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
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alexandria University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Tamer Habib, MD, Principal investigator, University of Alexandria
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06008067
- Sponsor's protocol ID
- TAPSESEPTIC
- Status last verified
- Aug 2023
- First submitted
- 17 Aug 2023
- Last updated
- 23 Aug 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Habib T, Ahmed I, Abayazeed R, Montasser M. The prognostic role of tricuspid annular plane systolic excursion in critically ill patients with septic shock. J Anesth Analg Crit Care. 2025 Apr 30;5(1):24. doi: 10.1186/s44158-025-00227-0.
PubMed 40307938
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Prognostic Role of Tricuspid Annular Plane Systolic Excursion in Critically Ill Patients With Septic Shock
- ClinicalTrials.gov ID
- NCT06008067
- Acronym / sponsor ID
- TAPSESEPTIC
- Conditions
- Septic Shock
- Keywords
- Critical Care, Septic Shock, Echocardiography, RV dysfunction
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Alexandria UniversityUniversity, hospital or other
- Study start
- 1 Apr 2023 (actual)
- Primary completion
- 1 Jul 2023 (actual)
- Study completion
- 1 Jul 2023 (actual)
- First posted
- 23 Aug 2023 (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 aim of this study is to evaluate the possible prognostic performance of RV dysfunction, as assessed by TAPSE, in non-cardiac patients with septic shock.
Detailed description
The objective is to investigate the prognostic performance of right ventricular dysfunction, as assessed by tricuspid annular plane systolic excursion (TAPSE), in non-cardiac patients with septic shock.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Survivors | – | Radiation: tricuspid annular plane systolic excursion (TAPSE)Patients who survived after day 28. |
| Non-survivors | – | Radiation: tricuspid annular plane systolic excursion (TAPSE)Patients who died at or before day 28. |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Age groups
- Adult
- Study population
- Adult patients (18 - 64 years old) with septic shock after admission according to 2016 consensus definition (Sepsis-3).
Key inclusion criteria (1 listed)
- Adult patients (18 - 64 years old) with septic shock after admission according to 2016 consensus definition (Sepsis-3).
Key exclusion criteria (11 listed)
- Pregnant females
- Trauma
- Documented coronary heart disease
- History of myocardial infarction
- Myocarditis
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 |
|---|---|---|
| tricuspid annular plane systolic excursion (TAPSE)Echocardiography | Radiation | Non-survivors, Survivors |
Primary outcome
28-day mortality
Time frame: Day 28
Mortality rate after at day 28.
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 23 Aug 2023.
- Derived from this study: PubMed 40307938Habib T, Ahmed I, Abayazeed R, Montasser M. The prognostic role of tricuspid annular plane systolic excursion in critically ill patients with septic shock. J Anesth Analg Crit Care. 2025 Apr 30;5(1):24. doi: 10.1186/s44158-025-00227-0.
- Individual participant dataSharing planned: No
Related trials for Septic Shock
Active, not recruitingPhase 4
Thymosin Alpha 1 and IgM Levels in Sepsis
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Vitamin C for Acute Kidney Injury in ACLF With Septic Shock: A Randomized Controlled Trial
Acute-on-Chronic Liver Failure (ACLF)
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ICU-SUCCEED for Survivors of Acute Respiratory Failure and Their Caregivers
Acute Respiratory Failure, Critical Illness
Not yet recruitingObservational study
Longitudinal Trajectories of Myocardial Work in Patients With Sepsis
Sepsis, Septic Shock Hyperdynamic
RecruitingObservational study
Immunothrombosis With Septic Shock Undergoing Renal Replacement Therapy With the OXIRIS Membrane
Sepsis
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.
Tamer Habib, MD principal investigator
University of Alexandria
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 Septic Shock, run by Alexandria 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 1 inclusion and 11 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 23 Aug 2023. 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?
28-day mortality (time frame: Day 28). 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 NCT06008067, 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 23 Aug 2023.