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RECRUITINGINTERVENTIONAL

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

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: - Age ≥ 18 years. - Provided written willing to sign a consent form 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. Who Should NOT Join This Trial: - 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. Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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.

Treatments Being Tested

DEVICE

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 (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.

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.

Locations (1)

BachMai Hospital, Hanoi Medical University
Hanoi, Vietnam