Trials / Recruiting

RecruitingNCT07062744

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

Status: Recruiting
Phase: N/A
Study type: Interventional
Enrollment: 108 (estimated)

Sponsor: Bach Mai Hospital · Academic / Other
Sex: All
Age: 18 Years
Healthy volunteers: Not accepted

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.

Conditions

Interventions

Type	Name	Description
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.

Timeline

Start date: 2025-05-27
Primary completion: 2027-12-01
Completion: 2027-12-30
First posted: 2025-07-14
Last updated: 2025-07-14

Locations

1 site across 1 country: Vietnam

Source: ClinicalTrials.gov record NCT07062744. Inclusion in this directory is not an endorsement.