Acute Myocardial Infarction (AMI), Cardiogenic Shock, Cardio Vascular Disease, Critical Care, Intensive Care, Emergency, Hemodynamic Management, Hemodynamic Monitoring, Hemodynamic Optimization, Pulmonary Artery Catheter Waveform Interpretation
Conditions
Keywords
Swan-Ganz, Pulmonary Artery Catheter, Cardiogenic shock, Hemodynamic management, Invasive hemodynamic, Right Heart Catheter
Brief summary
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.
Detailed 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.
Interventions
DEVICESwan-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.
DEVICESwan-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.
Sponsors
Hanoi Medical University
Bach Mai Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
This is a single-arm clinical trial conducted in an intensive care setting. All enrolled patients diagnosed with cardiogenic shock secondary to acute myocardial infarction will undergo goal-directed hemodynamic resuscitation guided by pulmonary artery catheter (Swan-Ganz) monitoring. The study employs a within-subject design, in which each participant serves as their own temporal control through serial hemodynamic assessments and treatment adjustments. There is no comparator or control group. The protocol includes standardized targets for preload, afterload, cardiac output, and oxygen delivery parameters, with data collected at predefined time points to evaluate hemodynamic response, organ perfusion, and short-term clinical outcomes.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| All-Cause Mortality at 30 Days | From the date of Swan-Ganz catheter insertion until the date of death from any cause, assessed up to 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 | From the date of Swan-Ganz catheter insertion until the hospital discharge date or the in-hospital death date, whichever comes first. | 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 | Up to 24 hours after Swan-Ganz catheter insertion | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Length of ICU stay | From the date of ICU admission until the date of ICU discharge, assessed up to 30 days. | Total number of days from emergency department ICU admission to emergency department ICU discharge for each participant. |
| Continuous Requirement for Renal Replacement Therapy (CRRT) | From the date of emergency department admission until the date of hospital discharge or death, assessed up to 30 days. | 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. |
| Incidence of Catheter-Related Complications | From the date of Swan-Ganz catheter insertion until the date of catheter removal, assessed up to 30 days. | 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) | From the date of endotracheal intubation and mechanical ventilation until the date of weaning mechanical ventilation success or death, assessed up to 30 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. |
Countries
Vietnam
Contacts
Primary ContactThang Xuan Pham, MD, PhD Candidate
Backup ContactTuan Anh Nguyen, Prof.PhD
Outcome results
None listed