An interventional study of Swan-Ganz IQ Pulmonary Arterial catheter and Swan-Ganz IQ catheter in Cardiogenic Shock, Pulmonary Artery Catheter Waveform Interpretation and Hemodynamic Management, sponsored by Bach Mai Hospital. Recruiting at 1 site in Vietnam. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-07-14.
Sponsored by Bach Mai Hospital · Not applicable, Interventional, and Treatment
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.
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.
Diagnosed with cardiogenic shock due to acute myocardial infarction according to IABP-SHOCK II (2012) criteria:
Exclusion Criteria:
Participants in this arm will undergo invasive hemodynamic monitoring using a Swan-Ganz catheter upon admission to the intensive care unit. Hemodynamic variables, including right atrial pressure (RAP), pulmonary artery pressure (PAP), pulmonary capillary wedge pressure (PCWP), cardiac output (CO), cardiac power output (CPO), and mixed venous oxygen saturation (SvO₂) will be continuously measured and used to guide resuscitation. Management will follow a goal-directed algorithm targeting predefined thresholds for preload, afterload, contractility, and oxygen delivery. All patients will receive standard care for acute myocardial infarction, and no control or comparator arm is included in this study.
Device: Swan-Ganz IQ Pulmonary Arterial catheter · Device: 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 (PCWP), Cardiac output (CO) by thermodilution, Mixed venous oxygen saturation (SvO₂). These parameters are recorded at predefined intervals and used to guide goal-directed hemodynamic resuscitation. Clinical interventions such as vasopressor/inotrope titration, fluid resuscitation, or ventilatory support will be adjusted accordingly. All procedures will follow institutional protocols and safety standards. Complications (e.g., arrhythmias, infection) will be monitored and managed per protocol.
Also known as: Flow-Directed Cathete, Plumonary Artery Catheter Swan-Ganz, Swan-Ganz catheterization, PAC, Invasive hemodynamic monitoring
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 (PCWP), Cardiac output (CO) by thermodilution, Mixed venous oxygen saturation (SvO₂). These parameters are recorded at predefined intervals and used to guide goal-directed hemodynamic resuscitation. Clinical interventions such as vasopressor/inotrope titration, fluid resuscitation, or ventilatory support will be adjusted accordingly. All procedures will follow institutional protocols and safety standards. Complications (e.g., arrhythmias, infection) will be monitored and managed per protocol.
Also known as: Cardiovascular Diagnostic Catheters, Pulmonary Artery Catheter, Swan-Ganz catheterization, Invasive hemodynamic monitoring
All-Cause Mortality at 30 Days
The proportion of participants who die from any cause within 30 days of Swan-Ganz catheter insertion. Mortality will be determined by review of hospital medical records, ICU documentation, or death certificates.
Time frame: From the date of Swan-Ganz catheter insertion until the date of death from any cause, assessed up to 30 days
In-Hospital Mortality
Proportion of enrolled patients who die from any cause during the index hospitalization after Swan-Ganz catheter insertion. Mortality will be determined by review of hospital medical records, ICU documentation.
Time frame: 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
Proportion of patients achieving predefined hemodynamic targets within 24 hours following Swan-Ganz catheter insertion. Targets include mean arterial pressure (MAP) ≥ 65 mmHg, cardiac index (CI) ≥ 2.2 L/min/m², central venous oxygen saturation (SvO₂) ≥ 60%, pulmonary capillary wedge pressure (PCWP) between 12 and 18 mmHg, and central venous pressure (CVP) between 8 and 12 mmHg.
Time frame: Up to 24 hours after Swan-Ganz catheter insertion
Length of ICU stay
Total number of days from emergency department ICU admission to emergency department ICU discharge for each participant.
Time frame: From the date of ICU admission until the date of ICU discharge, assessed up to 30 days.
Incidence of Catheter-Related Complications
The incidence of specific complications related to Swan-Ganz catheterization will be assessed, including ventricular arrhythmias, catheter malposition, CLABSI, bleeding at the insertion site, pneumothorax, hematoma, pericardial effusion, pulmonary artery catheter obstruction, thrombosis, and local site complications. Each complication will be reported individually as a percentage of the total study population.
Time frame: 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)
Number of calendar days that the patient remains on invasive mechanical ventilation from the time of endotracheal intubation until successful extubation or death. Reintubation within 48 hours will be considered part of the same ventilation episode.
Time frame: 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)
Proportion of participants who require any form of renal replacement therapy (intermittent hemodialysis, continuous renal replacement therapy, or sustained low-efficiency dialysis) during the index hospitalization for cardiogenic shock.
Time frame: From the date of emergency department admission until the date of hospital discharge or death, assessed up to 30 days.
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