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

NCT07062744 | Recruiting DMC

• 1 other identifier: 1
• Study Type: interventional
• Target: 108
• Locations: 1 country
• Sites: 1

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.

Conditions

Cardiogenic Shock; Pulmonary Artery Catheter Waveform Interpretation; Hemodynamic Management; Hemodynamic Optimization; Hemodynamic Monitoring; Acute Myocardial Infarction (AMI); Critical Care, Intensive Care; Emergency; Cardio Vascular Disease

Keywords

Swan-Ganz; Pulmonary Artery Catheter; Cardiogenic shock; Hemodynamic management; Invasive hemodynamic; Right Heart Catheter

Outcome Measures

Primary Outcomes (3)

• 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.

  From the date of Swan-Ganz catheter insertion until the date of death from any cause, assessed up to 30 days

• 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.

  From the date of Swan-Ganz catheter insertion until the hospital discharge date or the in-hospital death date, whichever comes first.

• 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.

  Up to 24 hours after Swan-Ganz catheter insertion

Secondary Outcomes (4)

• Length of ICU stay

  From the date of ICU admission until the date of ICU discharge, assessed up to 30 days.

• Incidence of Catheter-Related Complications

  From the date of Swan-Ganz catheter insertion until the date of catheter removal, assessed up to 30 days.

• 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.

• 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.

Study Arms (1)

Swan-Ganz-Guided Hemodynamic Resuscitation

EXPERIMENTAL

Participants in this arm will undergo invasive hemodynamic monitoring using a Swan-Ganz catheter upon admission to the intensive care unit. Hemodynamic variables, including right atrial pressure (RAP), pulmonary artery pressure (PAP), pulmonary capillary wedge pressure (PCWP), cardiac output (CO), cardiac power output (CPO), and mixed venous oxygen saturation (SvO₂) will be continuously measured and used to guide resuscitation. Management will follow a goal-directed algorithm targeting predefined thresholds for preload, afterload, contractility, and oxygen delivery. All patients will receive standard care for acute myocardial infarction, and no control or comparator arm is included in this study.

Device: Swan-Ganz IQ Pulmonary Arterial catheter; Device: Swan-Ganz IQ catheter

Interventions

Swan-Ganz IQ Pulmonary Arterial catheter DEVICE

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.

Also known as: Flow-Directed Cathete, Plumonary Artery Catheter Swan-Ganz, Swan-Ganz catheterization, PAC, Invasive hemodynamic monitoring

Swan-Ganz-Guided Hemodynamic Resuscitation

Swan-Ganz IQ catheter DEVICE

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.

Also known as: Cardiovascular Diagnostic Catheters, Pulmonary Artery Catheter, Swan-Ganz catheterization, Invasive hemodynamic monitoring

Swan-Ganz-Guided Hemodynamic Resuscitation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Bach Mai Hospital: lead
• Hanoi Medical University: collaborator

Study Sites (1)

BachMai Hospital, Hanoi Medical University

Hanoi, 100000, Vietnam

RECRUITING

Related Publications (18)

• Tehrani BN, Truesdell AG, Psotka MA, Rosner C, Singh R, Sinha SS, Damluji AA, Batchelor WB. A Standardized and Comprehensive Approach to the Management of Cardiogenic Shock. JACC Heart Fail. 2020 Nov;8(11):879-891. doi: 10.1016/j.jchf.2020.09.005.

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• Bertaina M, Galluzzo A, Rossello X, Sbarra P, Petitti E, Prever SB, Boccuzzi G, D'Ascenzo F, Frea S, Pidello S, Morici N, Sacco A, Oliva F, Valente S, De Ferrari GM, Ugo F, Rametta F, Attisani M, Zanini P, Noussan P, Iannaccone M. Prognostic implications of pulmonary artery catheter monitoring in patients with cardiogenic shock: A systematic review and meta-analysis of observational studies. J Crit Care. 2022 Jun;69:154024. doi: 10.1016/j.jcrc.2022.154024. Epub 2022 Mar 25.

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• Tehrani BN, Truesdell AG, Sherwood MW, Desai S, Tran HA, Epps KC, Singh R, Psotka M, Shah P, Cooper LB, Rosner C, Raja A, Barnett SD, Saulino P, deFilippi CR, Gurbel PA, Murphy CE, O'Connor CM. Standardized Team-Based Care for Cardiogenic Shock. J Am Coll Cardiol. 2019 Apr 9;73(13):1659-1669. doi: 10.1016/j.jacc.2018.12.084.

  PMID: 30947919 BACKGROUND

• Chetana Shanmukhappa S, Lokeshwaran S. Venous Oxygen Saturation. 2024 Sep 10. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2025 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK564395/

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• Kadosh BS, Berg DD, Bohula EA, Park JG, Baird-Zars VM, Alviar C, Alzate J, Barnett CF, Barsness GW, Burke J, Chaudhry SP, Daniels LB, DeFilippis A, Delicce A, Fordyce CB, Ghafghazi S, Gidwani U, Goldfarb M, Katz JN, Keeley EC, Kenigsberg B, Kontos MC, Lawler PR, Leibner E, Menon V, Metkus TS, Miller PE, O'Brien CG, Papolos AI, Prasad R, Shah KS, Sinha SS, Snell RJ, So D, Solomon MA, Ternus BW, Teuteberg JJ, Toole J, van Diepen S, Morrow DA, Roswell RO. Pulmonary Artery Catheter Use and Mortality in the Cardiac Intensive Care Unit. JACC Heart Fail. 2023 Aug;11(8 Pt 1):903-914. doi: 10.1016/j.jchf.2023.04.007. Epub 2023 Jun 14.

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  PMID: 30943781 BACKGROUND

• Kolte D, Khera S, Aronow WS, Mujib M, Palaniswamy C, Sule S, Jain D, Gotsis W, Ahmed A, Frishman WH, Fonarow GC. Trends in incidence, management, and outcomes of cardiogenic shock complicating ST-elevation myocardial infarction in the United States. J Am Heart Assoc. 2014 Jan 13;3(1):e000590. doi: 10.1161/JAHA.113.000590.

  PMID: 24419737 BACKGROUND

• Goldberg RJ, Spencer FA, Gore JM, Lessard D, Yarzebski J. Thirty-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. Circulation. 2009 Mar 10;119(9):1211-9. doi: 10.1161/CIRCULATIONAHA.108.814947. Epub 2009 Feb 23.

  PMID: 19237658 BACKGROUND

• Chow JY, Vadakken ME, Whitlock RP, Koziarz A, Ainsworth C, Amin F, McIntyre WF, Demers C, Belley-Cote EP. Pulmonary artery catheterization in patients with cardiogenic shock: a systematic review and meta-analysis. Can J Anaesth. 2021 Nov;68(11):1611-1629. doi: 10.1007/s12630-021-02083-2. Epub 2021 Aug 17.

  PMID: 34405356 BACKGROUND

• Rea ABBAC, Mihajlovic V, Vishram-Nielsen JKK, Brahmbhatt DH, Scolari FL, Wang VN, Nisar M, Fung NL, Otsuki M, Billia F, Overgaard CB, Luk A. Pulmonary Artery Catheter Usage and Impact on Mortality in Patients With Cardiogenic Shock: Results From a Canadian Single-Centre Registry. Can J Cardiol. 2024 Apr;40(4):664-673. doi: 10.1016/j.cjca.2023.12.005. Epub 2023 Dec 12.

  PMID: 38092192 BACKGROUND

• Bertaina M, Galluzzo A, Morici N, Sacco A, Oliva F, Valente S, D'Ascenzo F, Frea S, Sbarra P, Petitti E, Prever SB, Boccuzzi G, Zanini P, Attisani M, Rametta F, De Ferrari GM, Noussan P, Iannaccone M. Pulmonary Artery Catheter Monitoring in Patients with Cardiogenic Shock: Time for a Reappraisal? Card Fail Rev. 2022 Apr 26;8:e15. doi: 10.15420/cfr.2021.32. eCollection 2022 Jan.

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• Thiele H, Zeymer U, Thelemann N, Neumann FJ, Hausleiter J, Abdel-Wahab M, Meyer-Saraei R, Fuernau G, Eitel I, Hambrecht R, Bohm M, Werdan K, Felix SB, Hennersdorf M, Schneider S, Ouarrak T, Desch S, de Waha-Thiele S; IABP-SHOCK II Trial (Intraaortic Balloon Pump in Cardiogenic Shock II) Investigators; IABP-SHOCK II Investigators. Intraaortic Balloon Pump in Cardiogenic Shock Complicating Acute Myocardial Infarction: Long-Term 6-Year Outcome of the Randomized IABP-SHOCK II Trial. Circulation. 2019 Jan 15;139(3):395-403. doi: 10.1161/CIRCULATIONAHA.118.038201. Epub 2018 Nov 11.

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MeSH Terms

Conditions

Shock, Cardiogenic; Emergencies

Interventions

Catheterization, Swan-Ganz

Condition Hierarchy (Ancestors)

Myocardial Infarction; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis; Shock; Disease Attributes

Intervention Hierarchy (Ancestors)

Cardiac Catheterization; Heart Function Tests; Diagnostic Techniques, Cardiovascular; Diagnostic Techniques and Procedures; Diagnosis; Catheterization, Peripheral; Catheterization; Therapeutics; Endovascular Procedures; Vascular Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures; Investigative Techniques

Study Officials

• Thang Xuan Pham, MD, PhD Candidate

  Hanoi Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Thang Xuan Pham, MD, PhD Candidate

CONTACT

+84357991992; pxthanghmu92@gmail.com

Tuan Anh Nguyen, Prof.PhD

CONTACT

+8431115115; bstuanccbm@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Primary investigation

Model Details: 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.

Study Record Dates

• First Submitted: June 20, 2025
• First Posted: July 14, 2025
• Study Start: May 27, 2025
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 30, 2027
• Last Updated: July 14, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

VN (1)