Prognostic Value of Right Ventricular-pulmonary Arterial Coupling Assessed by Echocardiography in Septic Patients

Prognostic Value of Right Ventricular-pulmonary Arterial Coupling Assessed by Echocardiography in Septic Patients: A Prospective Observational Study

Sepsis and septic shock are common clinical conditions, representing a significant healthcare challenge due to their high mortality rates and increasing incidence. Sepsis-induced cardiomyopathy is a frequent complication, occurring in up to 44% of septic patients. This condition is associated with a two- to three-fold increase in mortality. Although sepsis-induced cardiomyopathy is typically diagnosed via echocardiography to assess left ventricular systolic function, both ventricles may be affected. Several studies have demonstrated that right ventricular dysfunction (RVD)/ right ventricular failure (RVF) was prevalent in sepsis and septic shock, with significant implications for prognosis and mortality.

The right ventricle (RV) has a distinct anatomical structure and function compared to the left ventricle, characterized by its high sensitivity to afterload variations. Even minor increases in afterload can severely impair RV contractile function. Meanwhile, septic patients often experience hypoxemic respiratory failure and require mechanical ventilation. This condition generates hypoxia-induced pulmonary vasoconstriction, which, combined with positive pressure ventilation, leads to increased pulmonary vascular resistance and elevated pulmonary arterial pressure. Additionally, systemic vasodilation reduces RV preload, while septic shock and vasopressor use further compromise right coronary perfusion, exacerbating RV contractile dysfunction. Consequently, simultaneous assessment of RV contractility and its afterload is crucial in septic patients.

Tricuspid annular plane systolic excursion (TAPSE) is a widely used echocardiographic parameter for evaluating RV systolic function. Pulmonary artery systolic pressure (sPAP) reflects RV afterload and can be estimated in the presence of tricuspid regurgitation. Recently, the TAPSE/sPAP ratio has been proposed as a clinical tool to assess right ventricle-pulmonary artery (RV-PA) coupling. This index has been shown to be associated with mortality in patients with pulmonary hypertension and heart failure. Several studies have been conducted to evaluate RV-PA coupling in sepsis and septic shocks, but these studies have limitations in terms of study design and patient selection.

In Vietnam, the issues of RVD/RVF in sepsis/septic shock have not been thoroughly investigated. Le Minh Khoi and colleagues reported that the incidence of reduced RV strain in septic patients was as high as 55.1%. Currently, no studies have specifically evaluated RV function, nor have any studies assessed RV-PA coupling in septic patients.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

215

Contacts and Locations

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

Study Contact

Study Contact Backup

Study Locations

      • Ho Chi Minh City, Vietnam, 700000
        • Recruiting
        • University Medical Center
        • Contact:
        • Contact:

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

All patients received treatment in the Intensive Care Unit (ICU) at the University Medical Center at Ho Chi Minh City during the study period

Description

Inclusion Criteria:

  • Diagnosed with sepsis,
  • Received treatment in the Intensive Care Unit (ICU) at the University Medical Center at Ho Chi Minh City during the study period.

Exclusion Criteria:

  • Pregnancy,
  • History of right ventricular myocardial infarction,
  • Acute coronary syndrome within the past 1 week,
  • Valvular heart diseases or a history of valve replacement surgery,
  • Congenital heart diseases or conditions involving intracardiac shunts.

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
Intervention / Treatment
Septic patients not having right ventricle-pulmonary artery uncoupling
  • First echocardiography: within 24 hours after study enrollment,
  • Second echocardiography: 48-72 hours after the initial echocardiography.
  • The recorded echocardiographic parameters include:

    • Morphological and Functional Parameters
    • Mitral Valve Flow Parameters
    • Tissue Doppler Echocardiography Parameters
    • STE Parameters for Left Ventricle Assessment
    • STE Parameters for Right Ventricle Assessment
Septic patients having right ventricle-pulmonary artery uncoupling
  • First echocardiography: within 24 hours after study enrollment,
  • Second echocardiography: 48-72 hours after the initial echocardiography.
  • The recorded echocardiographic parameters include:

    • Morphological and Functional Parameters
    • Mitral Valve Flow Parameters
    • Tissue Doppler Echocardiography Parameters
    • STE Parameters for Left Ventricle Assessment
    • STE Parameters for Right Ventricle Assessment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
In-hospital mortality
Time Frame: Feb 2027
Feb 2027

Secondary Outcome Measures

Outcome Measure
Time Frame
Duration of mechanical ventilation
Time Frame: Feb 2027
Feb 2027
Length of stay in Intensive Care Unit
Time Frame: Feb 2027
Feb 2027
Length of stay in hospital
Time Frame: Feb 2027
Feb 2027
Mortality in Intensive Care Unit
Time Frame: Feb 2027
Feb 2027

Collaborators and Investigators

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

Investigators

  • Study Chair: Khoi M Le, A/Prof. Dr., University Medical Center Ho Chi Minh City

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

April 16, 2025

Primary Completion (Estimated)

February 1, 2027

Study Completion (Estimated)

February 1, 2027

Study Registration Dates

First Submitted

March 14, 2025

First Submitted That Met QC Criteria

March 14, 2025

First Posted (Actual)

March 20, 2025

Study Record Updates

Last Update Posted (Actual)

May 27, 2026

Last Update Submitted That Met QC Criteria

May 22, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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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