The Prognostic Impact of Right Ventricular Systolic Dysfunction on the Survival of Patients With Sepsis and Septic Shock

Sepsis and Septic Shock Clinical Trial

Official title:

The Prognostic Impact of Right Ventricular Systolic Dysfunction on the Survival of Patients With Sepsis and Septic Shock

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06193109
• Other study ID #: Burapha university
• Status: Completed
• Start date: October 1, 2022
• Est. completion date: July 30, 2023

Study information

• Verified date: December 2023
• Source: Burapha University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This study sought to evaluate the association of right ventricular systolic dysfunction and 28-day in-hospital mortality in patients with sepsis and septic shock. Prospective cohort study of adult patients admitted at Burapha university hospital from October 1, 2022 through June 30, 2023 for sepsis and septic shock, who had an echocardiogram within 72 hours after admission for evaluating right ventricular systolic function. Right ventricular systolic dysfunction was defned by the American Society of Echocardiography criteria. Outcomes included 28-day in-hospital mortality, maximal blood lactate, length of intensive care unit(ICU) stay and duration of mechanical ventilation.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: July 30, 2023
• Est. primary completion date: June 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• aged 18 years or older

• diagnosed with sepsis or septic shock according to Sepsis-3 criteria

• received an echocardiogram within 72 hours after admission

Exclusion Criteria:

• prior diagnosis of pulmonary hypertension,

• cor-pulmonale,

• significant valvular heart disease,

• acute coronary syndrome,

• aortic dissection,

• heart failure

• inability to follow up within 28 days

Related Conditions & MeSH terms

• Sepsis
• Sepsis and Septic Shock
• Shock
• Shock, Septic
• Systolic Murmurs
• Toxemia

Locations

Country	Name	City	State
Thailand	Burapha University Hospital	Muang Chonburi	Chonburi

Sponsors (1)

Lead Sponsor	Collaborator
Burapha University

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	28 days in-hospital mortality	28 days in hospital mortality in patients with sepsis or septic shock	October 1, 2022 and June 30, 2023
Secondary	The prevalence of right ventricular systolic dysfunction	The prevalence of right ventricular systolic dysfunction in patients with sepsis and septic shock	October 1, 2022 and June 30, 2023
Secondary	Blood lactate levels	Blood lactate levels in patients with sepsis and septic shock	October 1, 2022 and June 30, 2023
Secondary	Lenght of ICU stay	Lenght of ICU stay in patients with sepsis and septic shock	October 1, 2022 and June 30, 2023
Secondary	Duration of mechanical ventilation	Duration of mechanical ventilation in patients with sepsis and septic shock	October 1, 2022 and June 30, 2023