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The Prognostic Role of Tricuspid Annular Plane Systolic Excursion in Critically Ill Patients With Septic Shock

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT06008067
Recruitment Status : Completed
First Posted : August 23, 2023
Last Update Posted : August 23, 2023
Sponsor:
Information provided by (Responsible Party):
Alexandria University

Study Description
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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.

Condition or disease Intervention/treatment
Septic Shock Radiation: tricuspid annular plane systolic excursion (TAPSE)

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
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Study Type : Observational
Actual Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Prognostic Role of Tricuspid Annular Plane Systolic Excursion in Critically Ill Patients With Septic Shock
Actual Study Start Date : April 1, 2023
Actual Primary Completion Date : July 1, 2023
Actual Study Completion Date : July 1, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Shock

Groups and Cohorts
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Group/Cohort Intervention/treatment
Survivors
Patients who survived after day 28.
 Radiation: tricuspid annular plane systolic excursion (TAPSE)
Echocardiography
Non-survivors
Patients who died at or before day 28.
 Radiation: tricuspid annular plane systolic excursion (TAPSE)
Echocardiography


Outcome Measures
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Primary Outcome Measures :
  1. 28-day mortality [ Time Frame: Day 28 ]
    Mortality rate after at day 28.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
Sampling Method:   Probability Sample
Study Population
Adult patients (18 - 64 years old) with septic shock after admission according to 2016 consensus definition (Sepsis-3).
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • 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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06008067


Locations
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Egypt
Faculty of Medicine, Alexandria University Hospitals
Alexandria, Egypt
Sponsors and Collaborators
Alexandria University
Investigators
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Principal Investigator: Tamer Habib, MD University of Alexandria
More Information
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Responsible Party: Alexandria University
ClinicalTrials.gov Identifier: NCT06008067    
Other Study ID Numbers: TAPSESEPTIC
First Posted: August 23, 2023    Key Record Dates
Last Update Posted: August 23, 2023
Last Verified: August 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Alexandria University:
Critical Care
Septic Shock
Echocardiography
RV dysfunction
Additional relevant MeSH terms:
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Shock, Septic
Shock
Pathologic Processes
Sepsis
 Infections
Systemic Inflammatory Response Syndrome
Inflammation