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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06193109
Other study ID # Burapha university
Secondary ID
Status Completed
Phase
First received
Last updated
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
Health authority
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

Study Design


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
See also
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