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.
Age ≥ 18 years.
Provided written informed consent to participate in the study.
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.
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).
Single group
Swan-Ganz IQ Pulmonary Arterial catheter
DeviceA 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.
Swan-Ganz IQ catheter
DeviceA 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.
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.
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.
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.
Length of ICU stay
Total number of days from emergency department ICU admission to emergency department ICU discharge for each participant.
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.
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.
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.
Click on the lead sponsor to view all of their trials.
Bach Mai Hospital
Lead sponsor
Hanoi Medical University
Collaborator
