NCT06193109

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2022

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2022

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 30, 2023

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

December 12, 2023

Completed
24 days until next milestone

First Posted

Study publicly available on registry

January 5, 2024

Completed
Last Updated

January 5, 2024

Status Verified

December 1, 2023

Enrollment Period

9 months

First QC Date

December 12, 2023

Last Update Submit

December 21, 2023

Conditions

Keywords

right ventricular systolic dysfunction

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • The prevalence of right ventricular systolic dysfunction

    October 1, 2022 and June 30, 2023

  • Blood lactate levels

    October 1, 2022 and June 30, 2023

  • Lenght of ICU stay

    October 1, 2022 and June 30, 2023

  • Duration of mechanical ventilation

    October 1, 2022 and June 30, 2023

Study Arms (1)

the patients with sepsis or septic shock

devide two groups : (1) They had right ventricular dysfunction and (2) They had no right venticular dysfunction.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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

You may qualify if:

  • aged 18 years or older
  • diagnosed with sepsis or septic shock according to Sepsis-3 criteria
  • received an echocardiogram within 72 hours after admission

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Burapha University Hospital

Muang Chonburi, Changwat Chon Buri, 20131, Thailand

Location

Related Publications (1)

  • Koowattanatianchai S, Kochaiyapatana P, Eungsuwat N, Rangsrisaeneepitak V, Thammakumpee K, Kaladee K. Significance of Right Ventricular Dysfunction in Predicting Short-Term Survival Among Patients With Sepsis and Septic Shock: A Prognostic Analysis. Crit Care Res Pract. 2025 Mar 14;2025:5511135. doi: 10.1155/ccrp/5511135. eCollection 2025.

MeSH Terms

Conditions

SepsisShock, Septic

Condition Hierarchy (Ancestors)

InfectionsSystemic Inflammatory Response SyndromeInflammationPathologic ProcessesPathological Conditions, Signs and SymptomsShock

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor Dr.

Study Record Dates

First Submitted

December 12, 2023

First Posted

January 5, 2024

Study Start

October 1, 2022

Primary Completion

June 30, 2023

Study Completion

July 30, 2023

Last Updated

January 5, 2024

Record last verified: 2023-12

Data Sharing

IPD Sharing
Will share
Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
Time Frame
after finishing the research and for 1 year after submission

Locations