NCT06008067

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2023

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2023

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

August 17, 2023

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 23, 2023

Completed
Last Updated

August 23, 2023

Status Verified

August 1, 2023

Enrollment Period

3 months

First QC Date

August 17, 2023

Last Update Submit

August 17, 2023

Conditions

Septic Shock

Keywords

Critical CareSeptic ShockEchocardiographyRV dysfunction

Outcome Measures

Primary Outcomes (1)

  • 28-day mortality

    Mortality rate after at day 28.

    Day 28

Study Arms (2)

Survivors

Patients who survived after day 28.

Radiation: tricuspid annular plane systolic excursion (TAPSE)

Non-survivors

Patients who died at or before day 28.

Radiation: tricuspid annular plane systolic excursion (TAPSE)

Interventions

tricuspid annular plane systolic excursion (TAPSE)RADIATION

Echocardiography

Non-survivorsSurvivors

Eligibility Criteria

Age18 Years - 64 Years
Sexall
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

Adult patients (18 - 64 years old) with septic shock after admission according to 2016 consensus definition (Sepsis-3).

You may qualify if:

  • Adult patients (18 - 64 years old) with septic shock after admission according to 2016 consensus definition (Sepsis-3).

You may not qualify if:

  • Pregnant females
  • Trauma
  • Documented coronary heart disease
  • History of myocardial infarction
  • Myocarditis
  • Thrombo-embolic pulmonary disease
  • Valvular heart disease
  • Corpulmonale
  • Arrhythmia
  • Known left ventricular ejection fraction \< 40%
  • Poor echocardiographic window

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Medicine, Alexandria University Hospitals

Alexandria, Egypt

Location

Related Publications (1)

  • 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.

    PMID: 40307938DERIVED

MeSH Terms

Conditions

Shock, Septic

Condition Hierarchy (Ancestors)

SepsisInfectionsSystemic Inflammatory Response SyndromeInflammationPathologic ProcessesPathological Conditions, Signs and SymptomsShock

Study Officials

  • Tamer Habib, MD

    University of Alexandria

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 17, 2023

First Posted

August 23, 2023

Study Start

April 1, 2023

Primary Completion

July 1, 2023

Study Completion

July 1, 2023

Last Updated

August 23, 2023

Record last verified: 2023-08

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)