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

December 21, 2023 updated by: Sukrisd Koowattanatianchai, Burapha University
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Thailand
    • Chonburi
      • Muang Chonburi, Chonburi, Thailand, 20131
        • Burapha University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

A prospective study was conducted at Burapha University Hospital, enrolling admitted patients diagnosed with sepsis and septic shock. Echocardiography was performed on these patients within 72 hours after admission

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
the patients with sepsis or septic shock
devide two groups : (1) They had right ventricular dysfunction and (2) They had no right venticular dysfunction.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
28 days in-hospital mortality
Time Frame: October 1, 2022 and June 30, 2023
28 days in hospital mortality in patients with sepsis or septic shock
October 1, 2022 and June 30, 2023

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The prevalence of right ventricular systolic dysfunction
Time Frame: October 1, 2022 and June 30, 2023
The prevalence of right ventricular systolic dysfunction in patients with sepsis and septic shock
October 1, 2022 and June 30, 2023
Blood lactate levels
Time Frame: October 1, 2022 and June 30, 2023
Blood lactate levels in patients with sepsis and septic shock
October 1, 2022 and June 30, 2023
Lenght of ICU stay
Time Frame: October 1, 2022 and June 30, 2023
Lenght of ICU stay in patients with sepsis and septic shock
October 1, 2022 and June 30, 2023
Duration of mechanical ventilation
Time Frame: October 1, 2022 and June 30, 2023
Duration of mechanical ventilation in patients with sepsis and septic shock
October 1, 2022 and June 30, 2023

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Burapha University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2022

Primary Completion (Actual)

June 30, 2023

Study Completion (Actual)

July 30, 2023

Study Registration Dates

First Submitted

December 12, 2023

First Submitted That Met QC Criteria

December 21, 2023

First Posted (Actual)

January 5, 2024

Study Record Updates

Last Update Posted (Actual)

January 5, 2024

Last Update Submitted That Met QC Criteria

December 21, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Burapha university

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Sharing Time Frame

after finishing the research and for 1 year after submission

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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