Overview
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.
Description
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.
Eligibility
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.