A Standardized and Comprehensive Approach to the Management of Cardiogenic Shock.
Behnam N Tehrani, Alexander G Truesdell, Mitchell A Psotka...
https://pubmed.ncbi.nlm.nih.gov/33121700Actively Recruiting
Phase Not Applicable
Age: 18Years +
All Genders
ID07062744
The Role of Swan-Ganz Catheter in Hemodynamic Resuscitation for Patients With Cardiogenic Shock
Led by Bach Mai Hospital · Updated on 2025-07-14
108
Participants Needed
1
Research Sites
4 weeks
Total Duration
On this page
Sponsors
B
Bach Mai Hospital
Lead Sponsor
H
Hanoi Medical University
Collaborating Sponsor
AI-Summary
What this Trial Is About
This research investigates the use of the Swan-Ganz catheter, a specialized pulmonary artery catheter, to improve heart and circulation monitoring in adults experiencing cardiogenic shock caused by acute myocardial infarction (AMI). Cardiogenic shock is a life-threatening condition where the heart cannot supply enough blood to organs, often following a severe heart attack. The study aims to evaluate how continuous hemodynamic data from the catheter can guide treatment and improve patient outcomes. Participants will have the Swan-Ganz catheter inserted through the neck or chest veins upon admission to the intensive care unit. This catheter continuously measures pressures in the heart and lungs, cardiac output, and oxygen saturation in the blood. These measurements help doctors adjust medications like inotropes and vasopressors, fluids, and ventilation support to stabilize heart function. The study follows a goal-directed treatment plan with specific targets for blood pressure, cardiac index, and oxygen levels. All patients also receive standard care for AMI. No control group is included. During the study, patients will be closely monitored with repeated hemodynamic measurements at scheduled intervals up to 24 hours after catheter insertion. Researchers will track treatment responses, 30-day survival, length of ICU stay, and any catheter-related complications. Data analysis will explore factors linked to successful heart stabilization. Participation lasts through hospital care with voluntary consent and confidentiality safeguards. Patients may withdraw anytime without affecting their usual medical treatment.
CONDITIONS
Brief Title
The Role of Swan-Ganz Catheter in Hemodynamic Resuscitation for Patients With Cardiogenic Shock
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Provided written informed consent to participate
- Diagnosed with cardiogenic shock due to acute myocardial infarction by IABP-SHOCK II (2012) criteria, including:
- Systolic blood pressure less than 90 mmHg for at least 30 minutes or needing vasopressors to keep it above 90 mmHg
- Evidence of end-organ hypoperfusion such as altered mental status, urine output below 30 mL/hour, cold extremities with mottled skin, or serum lactate above 2 mmol/L
You will not qualify if you...
- Presence of cervical cellulitis (neck infection)
- Inability to identify neck anatomy or history of cervical radiotherapy
- Coagulopathy with INR greater than 1.5 or platelet count less than 50 G/L
- End-stage chronic diseases such as advanced malignancy, advanced HIV, bedridden over 3 months, or decompensated liver cirrhosis (Child-Pugh class C)
- Patients with cardiac arrest or mechanical heart complications like myocardial rupture before catheter insertion
- Congenital heart defects or intracardiac shunts
- Refusal to participate by patient or legal representative
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
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Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Implementation
Duration - Up to 30 days
Participants undergo insertion of a Swan-Ganz catheter via the internal jugular or subclavian vein to enable continuous invasive hemodynamic monitoring. This catheter measures pressures and cardiac output to guide goal-directed resuscitation efforts.
Continuous monitoring during ICU stay
Treatment
Duration - Up to 30 days
Participants receive goal-directed hemodynamic resuscitation guided by continuous Swan-Ganz catheter measurements, including titration of vasopressors, inotropes, and fluid management to stabilize heart function and circulation.
Continuous care during ICU stay
Follow-up
Duration - Up to 30 days
Participants are monitored for catheter-related complications, ICU length of stay, and clinical outcomes including survival and organ function up to 30 days after catheter insertion.
Ongoing assessments throughout hospital stay
Trial Site Locations
Total: 1 location
1
BachMai Hospital, Hanoi Medical University
Hanoi, Vietnam, 100000
Actively Recruiting
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Research Team
T
Thang Xuan Pham, MD, PhD Candidate
T
Tuan Anh Nguyen, Prof.PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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Published Research Related To This Trial
Prognostic implications of pulmonary artery catheter monitoring in patients with cardiogenic shock: A systematic review and meta-analysis of observational studies.
Maurizio Bertaina, Alessandro Galluzzo, Xavier Rossello...
https://pubmed.ncbi.nlm.nih.gov/35344825Standardized Team-Based Care for Cardiogenic Shock.
Behnam N Tehrani, Alexander G Truesdell, Matthew W Sherwood...
https://pubmed.ncbi.nlm.nih.gov/30947919Pulmonary Artery Catheter Use and Mortality in the Cardiac Intensive Care Unit.
Bernard S Kadosh, David D Berg, Erin A Bohula...
https://pubmed.ncbi.nlm.nih.gov/37318422Twenty-Year Trends in the Incidence and Outcome of Cardiogenic Shock in AMIS Plus Registry.
Lukas Hunziker, Dragana Radovanovic, Raban Jeger...
https://pubmed.ncbi.nlm.nih.gov/30943781Trends in incidence, management, and outcomes of cardiogenic shock complicating ST-elevation myocardial infarction in the United States.
Dhaval Kolte, Sahil Khera, Wilbert S Aronow...
https://pubmed.ncbi.nlm.nih.gov/24419737Thirty-year trends (1975 to 2005) in the magnitude of, management of, and hospital death rates associated with cardiogenic shock in patients with acute myocardial infarction: a population-based perspective.
Robert J Goldberg, Frederick A Spencer, Joel M Gore...
https://pubmed.ncbi.nlm.nih.gov/19237658Pulmonary artery catheterization in patients with cardiogenic shock: a systematic review and meta-analysis.
Justin Y Chow, Maria E Vadakken, Richard P Whitlock...
https://pubmed.ncbi.nlm.nih.gov/34405356Pulmonary Artery Catheter Usage and Impact on Mortality in Patients With Cardiogenic Shock: Results From a Canadian Single-Centre Registry.
Ana Beatriz B A C Réa, Vesna Mihajlovic, Julie K K Vishram-Nielsen...
https://pubmed.ncbi.nlm.nih.gov/38092192