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

Official title

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

Overview

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.

Interventions

• Diagnostic test Echocardiography
  * 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 outcome measures

• In-hospital mortality [Time frame: Feb 2027]

Secondary outcome measures (4)

• Duration of mechanical ventilation [Time frame: Feb 2027]
• Length of stay in Intensive Care Unit [Time frame: Feb 2027]
• Length of stay in hospital [Time frame: Feb 2027]
• Mortality in Intensive Care Unit [Time frame: Feb 2027]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model

Cohort

Study locations

Vietnam · 1 center

• University Medical Center — Ho Chi Minh City

Publications

• Rudd KE, Johnson SC, Agesa KM, Shackelford KA, Tsoi D, Kievlan DR, Colombara DV, Ikuta KS, Kissoon N, Finfer S, Fleischmann-Struzek C, Machado FR, Reinhart KK, Rowan K, Seymour CW, Watson RS, West TE, Marinho F, Hay SI, Lozano R, Lopez AD, Angus DC, Murray CJL, Naghavi M. Global, regional, and national sepsis incidence and mortality, 1990-2017: analysis for the Global Burden of Disease Study. Lanc PMID 31954465
• Singer M, Deutschman CS, Seymour CW, Shankar-Hari M, Annane D, Bauer M, Bellomo R, Bernard GR, Chiche JD, Coopersmith CM, Hotchkiss RS, Levy MM, Marshall JC, Martin GS, Opal SM, Rubenfeld GD, van der Poll T, Vincent JL, Angus DC. The Third International Consensus Definitions for Sepsis and Septic Shock (Sepsis-3). JAMA. 2016 Feb 23;315(8):801-10. doi: 10.1001/jama.2016.0287. PMID 26903338
• Ehrman RR, Sullivan AN, Favot MJ, Sherwin RL, Reynolds CA, Abidov A, Levy PD. Pathophysiology, echocardiographic evaluation, biomarker findings, and prognostic implications of septic cardiomyopathy: a review of the literature. Crit Care. 2018 May 4;22(1):112. doi: 10.1186/s13054-018-2043-8. PMID 29724231
• Konstam MA, Kiernan MS, Bernstein D, Bozkurt B, Jacob M, Kapur NK, Kociol RD, Lewis EF, Mehra MR, Pagani FD, Raval AN, Ward C; American Heart Association Council on Clinical Cardiology; Council on Cardiovascular Disease in the Young; and Council on Cardiovascular Surgery and Anesthesia. Evaluation and Management of Right-Sided Heart Failure: A Scientific Statement From the American Heart Associati PMID 29650544
• Mikkelsen ME, Shah CV, Meyer NJ, Gaieski DF, Lyon S, Miltiades AN, Goyal M, Fuchs BD, Bellamy SL, Christie JD. The epidemiology of acute respiratory distress syndrome in patients presenting to the emergency department with severe sepsis. Shock. 2013 Nov;40(5):375-81. doi: 10.1097/SHK.0b013e3182a64682. PMID 23903852
• Wang S, Bashir Z, Chen EW, Kadiyala V, Sherrod CF, Has P, Song C, Ventetuolo CE, Simmons J, Haines P. Invasive Mechanical Ventilation Is Associated with Worse Right Ventricular Strain in Acute Respiratory Failure Patients. J Cardiovasc Dev Dis. 2024 Aug 9;11(8):246. doi: 10.3390/jcdd11080246. PMID 39195154
• Repesse X, Charron C, Vieillard-Baron A. Acute respiratory distress syndrome: the heart side of the moon. Curr Opin Crit Care. 2016 Feb;22(1):38-44. doi: 10.1097/MCC.0000000000000267. PMID 26627538
• Rudski LG, Lai WW, Afilalo J, Hua L, Handschumacher MD, Chandrasekaran K, Solomon SD, Louie EK, Schiller NB. Guidelines for the echocardiographic assessment of the right heart in adults: a report from the American Society of Echocardiography endorsed by the European Association of Echocardiography, a registered branch of the European Society of Cardiology, and the Canadian Society of Echocardiogra PMID 20620859

Identifiers

NCT: NCT06887140 · 173/GCN-HDDD

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗