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

• Sponsor: Alexandria University (Other)
• Overall Status: Completed
• CT.gov ID: NCT06008067
• Collaborator: (none)
• Enrollment: 100
• Location: 1
• Actual Duration (Months): 3
• Patients Per Site Per Month: 33.4

Study Details

Study Description

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	Phase
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

• 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: Apr 1, 2023
• Actual Primary Completion Date: Jul 1, 2023
• Actual Study Completion Date: Jul 1, 2023

Arms and Interventions

Arm	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

Primary Outcome Measures

1. 28-day mortality [Day 28]

   Mortality rate after at day 28.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 64 Years
• Sexes Eligible for Study: All

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

Locations

	Site	City	State	Country	Postal Code
1	Faculty of Medicine, Alexandria University Hospitals	Alexandria		Egypt

Sponsors and Collaborators

• Alexandria University

Investigators

• Principal Investigator: Tamer Habib, MD, University of Alexandria

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Alexandria University
• ClinicalTrials.gov Identifier: NCT06008067
• Other Study ID Numbers: TAPSESEPTIC
• First Posted: Aug 23, 2023
• Last Update Posted: Aug 23, 2023
• Last Verified: Aug 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• 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: Shock, Septic; Shock

Study Results

No Results Posted as of Aug 23, 2023