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NCT Number: NCT06887140

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Echocardiography

Diagnostic Test
  • 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

Primary outcomes

  1. In-hospital mortality

    Time frame: Feb 2027

Secondary outcomes

  1. Duration of mechanical ventilation

    Time frame: Feb 2027

  2. Length of stay in Intensive Care Unit

    Time frame: Feb 2027

  3. Length of stay in hospital

    Time frame: Feb 2027

  4. Mortality in Intensive Care Unit

    Time frame: Feb 2027

Study contacts

Contact information is provided by the study sponsor or research team.

Anh-Minh V Phan, MSc.

CONTACT

[email protected]

+84907216232

Khoi M Le, A/Prof. Dr.

CONTACT

[email protected]

+84919731386

Sponsors and collaborators

Lead sponsor

University Medical Center Ho Chi Minh City (UMC)

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Mar 20, 2025
Registry last updated
May 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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