The Role of Swan-Ganz Catheter in Hemodynamic Resuscitation for Patients With Cardiogenic Shock

Обзор

This clinical trial examines whether the use of the Swan-Ganz catheter, a specialized pulmonary artery catheter, can improve hemodynamic management and treatment outcomes in patients experiencing cardiogenic shock due to acute myocardial infarction (AMI). Cardiogenic shock is a critical condition marked by the heart's inability to supply adequate blood to the organs, often resulting from a severe heart attack. Despite advancements in care, the condition remains associated with high mortality. Effective monitoring of cardiovascular status is crucial in guiding timely and tailored treatment decisions. Participants in this study will undergo advanced hemodynamic monitoring using the Swan-Ganz catheter, which provides continuous data on cardiac output and other key parameters. This information enables physicians to better assess circulatory function and adjust therapies accordingly. The research will evaluate clinical characteristics, response to treatment, and 30-day outcomes in patients managed with this technique. The study also aims to identify factors associated with successful hemodynamic stabilization and potential complications related to catheter use. A total of 108 adult patients meeting specific eligibility criteria will be enrolled at Bach Mai Hospital over 3 years. Participation is voluntary, and all patients will continue to receive standard-of-care treatment. All personal and medical data will be handled with strict confidentiality.

Подробное описание

This is a clinical trial without a control group; a single-center study evaluates goal-directed hemodynamic optimization using pulmonary artery catheterization (Swan-Ganz catheter) in adult patients with cardiogenic shock secondary to acute myocardial infarction (AMI). Cardiogenic shock is characterized by a sustained systolic blood pressure \< 90 mmHg, evidence of end-organ hypoperfusion, and a low cardiac index (\< 2.2 L/min/m²) despite adequate filling pressures. In AMI patients, persistent low cardiac output and elevated systemic vascular resistance exacerbate tissue hypoxia, leading to multi-organ dysfunction.

Upon ICU admission, a pulmonary artery catheter will be inserted via the internal jugular or subclavian vein. Continuous measurements of right atrial pressure (RAP), right ventricular pressure, pulmonary artery pressure (PAP), pulmonary capillary wedge pressure (PCWP), cardiac output (via thermodilution), and mixed venous oxygen saturation (SvO₂) will be recorded at baseline and predefined intervals (0, 3, 6, 9, 12, 24 hours). Data will guide titration of inotropes (e.g., dobutamine targeting cardiac index ≥ 2.2 L/min/m²), vasopressors (e.g., norepinephrine to maintain MAP ≥ 65 mmHg), and fluid management (to achieve PCWP from 12 to 18 mmHg and CVP between 8 to 12 mmHg), SvO₂ keep above 60% to 80%, lactat \< 2 mmol/L.

The primary endpoint is 30-day all-cause mortality and in-hospital mortality. Secondary endpoints include duration of vasopressor/inotrope support, ICU length of stay, incidence of acute kidney injury, and catheter-related adverse events. Hemodynamic variables will be analyzed for outcomes using multivariate regression to identify predictors of successful hemodynamic stabilization.

All enrolled patients (n ≈ 108) will receive standard AMI care, including early revascularization and guideline-directed medical therapy in conjunction with the study protocol. Data collection, storage, and analysis will comply with Good Clinical Practice and the institution's ethics board requirements. Participation is voluntary, and patients may withdraw at any time without affecting their clinical management.

Вмешательства

• Устройство Swan-Ganz IQ Pulmonary Arterial catheter
  A pulmonary artery catheter (Swan-Ganz catheter) will be inserted via the right internal jugular or subclavian vein using a sterile technique and ultrasound guidance. The catheter is advanced into the pulmonary artery with real-time pressure waveform monitoring to confirm accurate positioning. Once inserted, the catheter provides continuous invasive hemodynamic monitoring, including measurements of: Right atrial pressure (RAP), Pulmonary artery pressure (PAP), Pulmonary capillary wedge pressure
• Устройство Swan-Ganz IQ catheter
  A pulmonary artery catheter (Swan-Ganz catheter) will be inserted via the right internal jugular or subclavian vein using a sterile technique and ultrasound guidance. The catheter is advanced into the pulmonary artery with real-time pressure waveform monitoring to confirm accurate positioning. Once inserted, the catheter provides continuous invasive hemodynamic monitoring, including measurements of: Right atrial pressure (RAP), Pulmonary artery pressure (PAP), Pulmonary capillary wedge pressure

Первичные конечные точки

• All-Cause Mortality at 30 Days [Срок оценки: From the date of Swan-Ganz catheter insertion until the date of death from any cause, assessed up to 30 days]
• In-Hospital Mortality [Срок оценки: From the date of Swan-Ganz catheter insertion until the hospital discharge date or the in-hospital death date, whichever comes first.]
• Hemodynamic stabilization was achieved within 24 hours [Срок оценки: Up to 24 hours after Swan-Ganz catheter insertion]

Вторичные конечные точки (4)

• Length of ICU stay [Срок оценки: From the date of ICU admission until the date of ICU discharge, assessed up to 30 days.]
• Incidence of Catheter-Related Complications [Срок оценки: From the date of Swan-Ganz catheter insertion until the date of catheter removal, assessed up to 30 days.]
• Duration of Mechanical Ventilation (Ventilator Days) [Срок оценки: From the date of endotracheal intubation and mechanical ventilation until the date of weaning mechanical ventilation success or death, assessed up to 30 days.]
• Continuous Requirement for Renal Replacement Therapy (CRRT) [Срок оценки: From the date of emergency department admission until the date of hospital discharge or death, assessed up to 30 days.]

Критерии участия

Критерии включения

• Age ≥ 18 years.
• Provided written informed consent to participate in the study.
• Diagnosed with cardiogenic shock due to acute myocardial infarction according to IABP-SHOCK II (2012) criteria:

• Systolic blood pressure (SBP) < 90 mmHg for at least 30 minutes, or requiring vasopressor agents to maintain SBP > 90 mmHg.
• Evidence of end-organ hypoperfusion, indicated by at least one of the following: Altered mental status, Urine output < 30 mL/hour, Cold extremities with mottled skin, Serum lactate level > 2 mmol/L.

Критерии исключения

• Presence of cervical cellulitis.
• Inability to identify neck anatomy or history of cervical radiotherapy.
• Coagulopathy (INR > 1.5 and/or platelet count < 50 G/L).
• End-stage chronic diseases, including: Advanced malignancy, advanced-stage HIV, bedridden patients for more than 3 months, decompensated liver cirrhosis (Child-Pugh class C).
• Patients with cardiac arrest or mechanical complications such as myocardial rupture prior to Swan-Ganz catheterization.
• Congenital heart defects or intracardiac shunts. Refusal of participation by the patient or their legal representative.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Вьетнам · 1 центр

• BachMai Hospital, Hanoi Medical University — Hanoi

Публикации

• Tehrani BN, Truesdell AG, Psotka MA, Rosner C, Singh R, Sinha SS, Damluji AA, Batchelor WB. A Standardized and Comprehensive Approach to the Management of Cardiogenic Shock. JACC Heart Fail. 2020 Nov;8(11):879-891. doi: 10.1016/j.jchf.2020.09.005. PMID 33121700
• Bertaina M, Galluzzo A, Rossello X, Sbarra P, Petitti E, Prever SB, Boccuzzi G, D'Ascenzo F, Frea S, Pidello S, Morici N, Sacco A, Oliva F, Valente S, De Ferrari GM, Ugo F, Rametta F, Attisani M, Zanini P, Noussan P, Iannaccone M. Prognostic implications of pulmonary artery catheter monitoring in patients with cardiogenic shock: A systematic review and meta-analysis of observational studies. J Cri PMID 35344825
• Tehrani BN, Truesdell AG, Sherwood MW, Desai S, Tran HA, Epps KC, Singh R, Psotka M, Shah P, Cooper LB, Rosner C, Raja A, Barnett SD, Saulino P, deFilippi CR, Gurbel PA, Murphy CE, O'Connor CM. Standardized Team-Based Care for Cardiogenic Shock. J Am Coll Cardiol. 2019 Apr 9;73(13):1659-1669. doi: 10.1016/j.jacc.2018.12.084. PMID 30947919
• Chetana Shanmukhappa S, Lokeshwaran S. Venous Oxygen Saturation. 2024 Sep 10. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2026 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK564395/ PMID 33232065
• Kadosh BS, Berg DD, Bohula EA, Park JG, Baird-Zars VM, Alviar C, Alzate J, Barnett CF, Barsness GW, Burke J, Chaudhry SP, Daniels LB, DeFilippis A, Delicce A, Fordyce CB, Ghafghazi S, Gidwani U, Goldfarb M, Katz JN, Keeley EC, Kenigsberg B, Kontos MC, Lawler PR, Leibner E, Menon V, Metkus TS, Miller PE, O'Brien CG, Papolos AI, Prasad R, Shah KS, Sinha SS, Snell RJ, So D, Solomon MA, Ternus BW, Teu PMID 37318422
• Hunziker L, Radovanovic D, Jeger R, Pedrazzini G, Cuculi F, Urban P, Erne P, Rickli H, Pilgrim T; AMIS Plus Registry Investigators are listed in alphabetic order with the names of the local principal investigators. Twenty-Year Trends in the Incidence and Outcome of Cardiogenic Shock in AMIS Plus Registry. Circ Cardiovasc Interv. 2019 Apr;12(4):e007293. doi: 10.1161/CIRCINTERVENTIONS.118.007293. PMID 30943781
• Kolte D, Khera S, Aronow WS, Mujib M, Palaniswamy C, Sule S, Jain D, Gotsis W, Ahmed A, Frishman WH, Fonarow GC. Trends in incidence, management, and outcomes of cardiogenic shock complicating ST-elevation myocardial infarction in the United States. J Am Heart Assoc. 2014 Jan 13;3(1):e000590. doi: 10.1161/JAHA.113.000590. PMID 24419737
• Goldberg RJ, Spencer FA, Gore JM, Lessard D, Yarzebski J. Thirty-year trends (1975 to 2005) in the magnitude of, management of, and hospital death rates associated with cardiogenic shock in patients with acute myocardial infarction: a population-based perspective. Circulation. 2009 Mar 10;119(9):1211-9. doi: 10.1161/CIRCULATIONAHA.108.814947. Epub 2009 Feb 23. PMID 19237658

Идентификаторы

NCT: NCT07062744 · 1

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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