The Role of Swan-Ganz Catheter in Hemodynamic Resuscitation for Patients With Cardiogenic Shock
Phase: NA
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
Sponsor: Bach Mai Hospital

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STUDY DOCUMENT COVER PAGE 
Official Study Title: 
The Role of Swan–Ganz Catheter in Hemodynamic Resuscitation for 
Patients with Cardiogenic Shock due to Acute Myocardial Infarction 
NCT Number: 
Pending 
Document Title: 
Study Protocol 
Document Date: 
June 21, 2025 
Version: 
1.0 
Principal Investigator (PI): 
Thang Pham Xuan 
Emergency Center, BachMai Hospital 
Sponsor: 
Investigator-Initiated Study 
Document Type for ClinicalTrials.gov Submission: 
7 Study Protocol 
6 Statistical Analysis Plan (SAP) 
6 Informed Consent Form (ICF) 
6 Other: ______________________ 
Confidentiality Notice: 
This document is intended for public posting on ClinicalTrials.gov. It 
does not contain any identifiable private information of research 
participants. 
 
 
 
 
 
 
 
 
 
 
 
 

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STUDY PROTOCOL 
Thang Pham Xuan1,2, Tuan Anh Nguyen1,2, Quan Huu Nguyen1,3, Hung Tran Ha2, Dat 
Nguyen Tuan1 , Minh Duy Nguyen2, Tu Nguyen Thanh1, Dai Khuong Quoc1,  Linh Nguyen 
Quoc1,2, Hieu Nguyen Minh1 , Nghia Nguyen Van1 , Thong Tran Huu1 
 
1 Emergency Center, BachMai Hospital, Hanoi, Vietnam, 2 VNU University of Medicine and Pharmacy, 
Hanoi, Vietnam, 3 Hanoi Medical University, Hanoi, Vietnam 
* pxthanghmu92@gmail.com 
 
 
Background: Cardiogenic shock (CS) is a life-threatening condition characterized by 
inadequate tissue perfusion due to severe impairment of myocardial contractility, most 
frequently resulting from acute myocardial infarction (AMI) with left ventricular 
dysfunction. Although contemporary therapies have improved, CS continues to carry a 
high in-hospital mortality rate. Timely and targeted hemodynamic resuscitation remains 
a cornerstone of management but poses significant challenges, particularly in 
advanced shock states. 
Objective: This study aims to evaluate the role of invasive hemodynamic monitoring 
using a pulmonary artery catheter (PAC) in guiding goal-directed therapy and improving 
outcomes in patients with cardiogenic shock (CS) secondary to acute myocardial 
infarction. 
Methods: A prospective observational study was conducted at Bachmai Hospital 
(2025–2027). Adult patients with AMI-induced CS were enrolled and underwent early 
PAC-guided hemodynamic assessment. Hemodynamic targets within the first 24 hours 
included: cardiac index (CI) ≥ 2.2 L/min/m², cardiac power output (CPO) ≥ 0.6 W, 
pulmonary artery occlusion pressure (PAOP) between 15–18 mmHg, right atrial 
pressure (RAP) between 8–12 mmHg, mixed venous oxygen saturation (SvO₂) ≥ 60%, 
and lactate clearance. Vasoactive agents and fluid management were titrated 
accordingly. 
Outcomes: Primary outcomes were in-hospital mortality and 30-day mortality. 
Secondary outcomes included length of stay in ICU, length of stay in hospital, duration 
of vasopressor use, and PAC-related complications. 
Conclusion: Continuous hemodynamic monitoring via Swan–Ganz catheter enables 
precise characterization of cardiogenic shock phenotype and facilitates real-time, 
targeted interventions. This study is expected to provide critical data on the 
effectiveness of PAC-guided resuscitation in improving survival and hemodynamic 
stabilization in patients with AMI-related CS in a Vietnamese tertiary care setting. 
Introduction 
 
Cardiogenic shock (CS) is an acute circulatory failure state marked by critically low 
cardiac output, leading to tissue hypoperfusion and life-threatening oxygen debt. Acute 
myocardial infarction (AMI) remains the leading etiology, accounting for over 80% of 
CS cases with left ventricular dysfunction [1],[2],[3]. Despite advances in 
revascularization and mechanical support, in-hospital mortality remains high, ranging 
from 27% to 51% [4], [5], [6]. AMI with extensive left ventricular dysfunction accounts 
for approximately 81% of CS cases. Early recognition and targeted hemodynamic 
resuscitation are crucial for improving clinical outcomes. However, the clinical 
diagnosis and management of CS remain complex due to the heterogeneous nature of 
its presentation and the dynamic progression of hemodynamic instability. 
The IABP-SHOCK II criteria provide a standardized clinical definition of CS, 
encompassing both hypotension (systolic blood pressure < 90 mmHg for ≥30 minutes 
or need for vasopressors to maintain SBP > 90 mmHg) and evidence of end-organ 
hypoperfusion manifested as altered mental status, oliguria (<30 mL/hour), cold 

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extremities or mottled skin, and elevated serum lactate (>2 mmol/L) [2]. Invasive 
hemodynamic monitoring plays a pivotal role in resuscitating cardiogenic shock, 
particularly when clinical markers such as blood pressure, urine output, or serum 
lactate levels become insufficient to guide complex therapeutic decisions. Advanced 
parameters, including cardiac index (CI), cardiac power output (CPO), pulmonary 
artery occlusion pressure (PAOP), right atrial pressure (RAP), and mixed venous 
oxygen saturation (SvO₂), offer a quantitative assessment of preload, afterload, 
contractility, and systemic oxygen delivery. The pulmonary artery catheter (PAC) 
enables real-time measurement of these variables and supports individualized titration 
of fluids, vasopressors, and inotropes. Recent data suggest PAC-guided management 
may improve short-term outcomes in CS. 
In Vietnam, clinical data on the application of PAC in CS remain limited. This study 
aims to evaluate the role of Swan–Ganz catheterization in hemodynamic resuscitation 
among patients with cardiogenic shock due to acute myocardial 椃narction at Bachmai 
Hospital, focusing on achieving early hemodynamic goals (CI, CPO, PAOP, RAP, 
SvO₂, lactate) within 24 hours and their association with in-hospital and 30-day 
mortality. 
Methods 
 
Study design 
The study design is a clinical trial without a control group, single-center (the Emergency 
Center, Bachmai Hospital). Eligible patients will be consecutively enrolled between 
January 2025 and December 2027 based on predefined inclusion and exclusion criteria 
(Table 1). A study flow chart is shown in Fig. 1. 
Fig 1. Bold the figure title. Figure caption text here, please use this space for the figure 
panel descriptions instead of using subfigure commands. A: Lorem ipsum dolor sit 
amet. B: Consectetur adipiscing elit. 
Ethical approval 
All research documents were approved by the Ethics Committee of Bach Mai Hospital 
according to decision No. 33/BM-HDDD. All patients and family members agree to 
participate in the study and have signed an informed consent. All consent data are 
obtained in both verbal and written formats. 
Sample size calculation 
We applied the formula for estimating a proportion with a specified absolute precision 
to calculate the required sample size: 
n = 
(�㕍{1−�㗼
2})
2
⋅�㕃 (1 − �㕃)
�㕑2
 
Where: n is the required sample size, P is the estimated in-hospital mortality among 
patients with cardiogenic shock managed using pulmonary artery catheter (PAC); 
based on the study by Hernandez et al., P = 35% [46], d is the absolute margin of error 
(set at 9%), Z is the standard normal deviate corresponding to a confidence level of 
95% (Z = 1.96), α is the significance level (set at 0.05). Substituting the values into the 
formula, we obtain a required sample size of n = 108. 
At Bach Mai Hospital, approximately two patients are diagnosed with cardiogenic shock 
and admitted daily across four specialized units: the Cardiology Department (C1), the 
Coronary Care Unit (Q1), the Emergency Center, and the Intensive Care Center. This 
corresponds to an estimated 730 admissions for cardiogenic shock annually. Assuming 
a 20% attrition rate due to incomplete data collection or exclusion criteria, we anticipate 
approximately 584 eligible patients per year. Therefore, the target sample size is 
considered feasible within the proposed study period. 
 
 
 
 
 
 
 

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Fig 1. Flow chart of the study design. PAC is Pulmonary Artery Catheter; CPO is 
Cardiac Power Output; CVP is Central Vein Pressure; PAOP is Pulmonary Artery 
Occlusion Pressure. 
 
Table 1. Eligibility criteria for the study: 
Inclusion criteria 
Participants will be eligible for enrollment if they meet all of the following 
criteria: 
• 
Aged ≥18 years and voluntarily provide informed consent to participate 
in the study. 
• 
Diagnosed with cardiogenic shock secondary to acute myocardial 
infarction (AMI), based on the IABP–SHOCK II criteria, including: 
+ Systolic blood pressure (SBP) <90 mmHg for at least 30 minutes, 
or requiring vasopressor support to maintain SBP >90 mmHg. 
+ Evidence of end-organ hypoperfusion, defined by at least one of 
the following: Altered mental status, Urine output <30 mL/hour, Cold 
extremities or mottled skin, Serum lactate >2 mmol/L. 
Exclusion Criteria:  
Patients meeting any of the following criteria will be excluded from the study: 
• 
Active cervical cellulitis or history of neck irradiation, or inability to identify 
cervical vascular anatomy. 
• 
Coagulopathy, defined as an international normalized ratio (INR) >1.5 
• 
Patient screening and enrollment 
• 
Diagnosis: Cardiogenic shock (CS) due to acute myocardial infarction 
(AMI), based on IABP–SHOCK II criteria. 
Percutaneous coronary intervention (PCI) ± angioplasty, and stent insertion 
Inclusion and exclusion criteria were applied (Table 1) 
Targeted hemodynamic monitoring within 
24h (every 3 hours): 
• 
CI > 2.2 L/min/m2. 
• 
CPO ≥ 0.6 (W) 
• 
CVP: 8 – 12 mmHg. 
• 
PAOP: 15 – 18 mmHg. 
• 
SvO2: 60-80%. 
• 
Lactat < 2 mmol/L. 
Primary outcome: 
- 
Achievement of 24-hour hemodynamic goals 
- 
30-day mortality. 
Secondary outcome: 
- 
PAC-related complications 
- 
Feasibility and challenges of catheter placement 
Catheter insertion details 
documented:  
• 
Site of access,  
• 
Catheter length, 
• 
Waveform confirmation.  
• 
Any procedural 
complications. 
Proceed with placement of Swan–Ganz pulmonary artery catheter (PAC) 

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and/or a platelet count <50 × 10⁹/L. 
• 
Terminal-stage chronic illnesses, including: 
+ Advanced malignancy with palliative intent. 
+ End-stage HIV infection. 
+ Liver cirrhosis classified as Child–Pugh class C. 
+ End-stage renal disease requiring maintenance hemodialysis. 
+ Prolonged immobility (bedridden >3 months). 
+ Pre-existing cardiac arrest or mechanical complications of 
myocardial infarction (e.g., ventricular free wall rupture) before 
Swan–Ganz catheter insertion. 
+ Known intracardiac shunts or congenital heart defects that may 
affect hemodynamic measurements. 
+ Refusal to participate or withdrawal of informed consent at any 
point during the study. 
Statistical analysis: 
Statistical analyses will be conducted using SPSS software, version 16.0 (IBM Corp., 
Armonk, NY, USA). Continuous variables will be assessed for normality using the 
Shapiro–Wilk test. Data with normal distribution will be reported as mean ± standard 
deviation (SD), whereas non-normally distributed variables will be presented as median 
and interquartile range (IQR). Categorical variables will be summarized as absolute 
counts and proportions.  
Comparisons of continuous variables between two independent groups (e.g., survivors 
vs. non-survivors) will be performed using the independent t-test for normally 
distributed data or the Mann–Whitney U test for skewed distributions. The Chi-square 
test or Fisher’s exact test will be applied for between-group comparisons of categorical 
variables. 
Paired t-test or Wilcoxon signed-rank test will be used to evaluate within-group changes 
in hemodynamic parameters over time. Where applicable, one-way ANOVA will be 
used to compare mean values across more than two subgroups. 
Pearson or Spearman correlation analysis will be employed to explore associations 
between continuous variables such as cardiac index (CI), pulmonary artery occlusion 
pressure (PAOP), and serum lactate levels. 
Receiver operating characteristic (ROC) curve analysis will be performed to evaluate 
the discriminatory performance of selected hemodynamic indices in predicting 30-day 
mortality. Area under the curve (AUC) values will be interpreted using standard 
benchmarks, with values >0.8 indicating good predictive accuracy. 
Multivariable logistic regression will be used to identify independent predictors of 
unfavorable 30-day outcomes. Variables included in the model will be selected based 
on clinical plausibility and significance in univariate analysis. Adjusted odds ratios 
(ORs) and 95% confidence intervals (CIs) will be reported to quantify associations. 
All statistical tests will be two-sided, and a p-value of less than 0.05 will be considered 
statistically significant. All data inputs from the patients are recorded and reported in 
Table 2. 
Primary outcome: 
The primary outcome is the rate of achieving hemodynamic targets within the first 24 
hours following Swan–Ganz catheter. 
Hemodynamic targets are defined as: 
• 
MAP ≥ 65 mmHg. 
• 
Cardiac Index (CI) ≥ 2.2 L/min/m². 
• 
Pulmonary Capillary Wedge Pressure (PCWP) between 12–15 mmHg. 
• 
Central Venous Pressure (CVP) between 8–12 mmHg. 
• 
Mixed venous oxygen saturation (SvO₂) ≥ 65%. 
• 
Lactat < 2 mmol/L. 
• 
VIS (Vasoactive Inotropic Score) 
Additionally, 30-day all-cause mortality and in-hospital mortality will be assessed 
as clinical endpoints related to early hemodynamic stabilization. 

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Secondary outcomes: 
• 
Advantages and disadvantages of the PAC placement procedure. 
• 
Complications related to PAC. 
• 
Length of stay in ICU. 
• 
Length of stay in hospital. 
• 
Ventilator days. 
• 
Renal replacement therapy requirement. 
Table 2. Clinical and subclinical characteristics of patients. 
Variable 
Unit / Classification 
Patient Characteristics 
 
Age 
Years (mean ± SD) 
Sex 
Male / Female (n, %) 
Body mass index (BMI) 
kg/m² (mean ± SD) 
Medical history 
 
Hypertension 
Yes / No (n, %) 
Diabetes mellitus 
Yes / No (n, %) 
Dyslipidemia 
Yes / No (n, %) 
Clinical Scores 
 
SCAI stage 
A, B, C, D, E (n, %) 
APACHE II score 
Mean ± SD 
SOFA score 
Mean ± SD 
Clinical Presentation 
 
Time from symptom onset to admission 
Hours (mean ± SD) 
Type of AMI 
I, II, III, IV, V 
Infarct location 
Anterior / Inferior / Lateral / etc. 
Reperfusion strategy 
PCI / Fibrinolysis / None 
Mechanical ventilation 
Yes / No (n, %) 
Renal replacement therapy 
Yes / No (n, %) 
Laboratory Values 
 
Lactate 
mmol/L  
NT-proBNP / BNP 
pg/mL  
Troponin I/T 
ng/mL  
Serum creatinine, AST, ALT, and BIL 
µmol/L 
eGFR 
mL/min/1.73 m² 
Hemodynamic (PAC) 
 
Mean arterial pressure (MAP) 
mmHg 
Central venous pressure (CVP) 
mmHg 
Pulmonary artery pressure (systolic/diastolic/mean) mmHg 
Pulmonary capillary wedge pressure (PCWP) 
mmHg 
Cardiac index (CI) 
L/min/m² 
Systemic vascular resistance (SVR) 
dyn·s·cm⁻⁵ 
Mixed venous oxygen saturation (SvO₂) 
% 
Cardiac power output (CPO) 
Watts (W) 
Pulmonary artery pulsatility index (PAPi) 
(PASP 2 PADP) / RAP 
Vasopressor-Inotropic Score (VIS) 
Unitless 

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Table 3. Technical Challenges: 
Category 
Details (from research case record form) 
PAC-Related Complications 
 
Bleeding at the insertion 
Yes / No  
Pneumothorax 
Yes / No  
Hematoma 
Yes / No 
Pericardial effusion 
Yes / No 
PAC obstruction 
Yes / No 
PAC-related thrombosis 
Yes / No  
Local site complications. 
Bleeding, dislodgement, redness, skin 
breakdown, suture loss. 
Technical Challenges 
 
Time factors 
Time to prepare, sheath insertion, wave 
detection (RA, RV, PA, PAOP) all documented. 
Number of attempts 
PAC successfully placed on 1st / 2nd / 3rd  
PAC position 
Pulmonary Artery (Right/Left) 
Infection risk 
Cultures of PAC tip, blood (CVC, PAC, 
peripheral). 
Discussion 
 
The Swan–Ganz pulmonary artery catheter (PAC) remains the most comprehensive 
bedside tool for real-time, invasive hemodynamic assessment, offering continuous data 
on cardiac output (CO), cardiac index (CI), pulmonary capillary wedge pressure 
(PCWP), systemic vascular resistance (SVR), and mixed venous oxygen saturation 
(SvO₂). These parameters enable accurate classification of shock phenotypes (e.g., 
left-dominant, right-dominant, mixed), optimization of fluid resuscitation, and titration of 
vasopressors, inotropes, or mechanical circulatory support (MCS) devices [7], [8], [9], 
[10], [11]. In a pivotal 2021 study published in the Canadian Journal of Cardiology, 
Réa et al. reported that among 1,043 CS patients, PAC use (47%) was associated with 
a significantly lower in-hospital mortality (29.3%) compared to those not monitored 
invasively (36.2%; P=0.02), particularly in patients classified as SCAI stages D and E. 
Furthermore, the PAC group had significantly higher rates of MCS device utilization 
(Impella, LVAD, RVAD), suggesting that invasive hemodynamic data guided more 
aggressive and timely interventions [12]. This survival benefit was further corroborated 
in a large-scale meta-analysis by Chow et al., involving over 2.7 million patients with 
CS. The use of PAC was associated with improved survival to hospital discharge 
(RR=0.72, 95% CI: 0.60–0.87) [9]. Similarly, Bertaina et al. (2022) analyzed pooled 
data from six studies totaling 1.16 million CS cases and found lower short-term mortality 
in the PAC group (36% vs. 47%, OR=0.71, 95% CI: 0.59–0.87, P<0.01), along with 
increased MCS use (59% vs. 48%, OR=1.6, 95% CI: 1.27–2.02, P<0.01) [7]. Further 
reinforcing these findings, Ta Kyung et al. conducted a 21-year retrospective analysis 
of 950,530 CS cases and found that PAC placement was significantly associated with 
reduced mortality (OR=0.63, 95% CI: 0.41–0.97) [13]. In another multicenter study 
across 34 cardiac intensive care units, Kadosh et al. found lower mortality in PAC-
monitored patients (28.4%) compared to those without PAC (35%, OR=0.79, 95% CI: 
0.66–0.96, P=0.017) [14]. 
Our study seeks to further contribute to this evidence base by evaluating whether early 
PAC-guided resuscitation can improve achievement of hemodynamic targets (CI ≥ 2.2 
L/min/m², CPO ≥ 0,6W, PCWP beetween 12 and 18 mmHg, SvO₂ from 60% to 80%, 
lactat <2 mmol/L) and reduce 30-day mortality and in-hospital mortality. Mixed Venous 
Oxygen Saturation (SvO₂) and Oxygen Extraction Ratio (O₂ER): Provide dynamic 
insight into balance between oxygen delivery and consumption; SvO₂ <60% or O₂ER 
>30% may signal insufficient perfusion [15]. Cardiac Power Output (CPO) and Cardiac 
Power Index (CPI): Strongly predictive of survival in CS; CPO <0.6 W and CPI <0.3 

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W/m² are associated with poor prognosis [16], [17], [18], [19]. Beyond static 
hemodynamic thresholds, continuous trend analysis of dynamic parameters as 
implemented through serial measurements every 3 hours during the first 24 hours is 
used to evaluate therapeutic efficacy and identify early signs of hemodynamic 
deterioration. For example, a rising cardiac index (CI) trajectory coupled with a 
declining lactate and improving SvO₂ trend reflects restored oxygen delivery relative to 
demand, indicating resuscitation success. In contrast, plateauing or declining CI 
despite escalating inotropic support, or a persistently low SvO₂ <60% despite 
normalized mean arterial pressure (MAP), may suggest underlying myocardial reserve 
exhaustion or maladaptive vasodilation. Likewise, trends in pulmonary capillary wedge 
pressure (PCWP) can indicate evolving left ventricular compliance or fluid overload, 
while progressively rising right atrial pressure (RAP) or decreasing PAPi values can 
herald right ventricular failure or volume mismanagement. Hemodynamic phenotyping 
is critical in guiding device-specific mechanical circulatory support (MCS) strategies. 
For example, a low PAPi (<1.0) with elevated RAP and preserved PCWP may indicate 
isolated RV-failure, suggesting the need for targeted right ventricular assist devices 
(RVAD) or temporary RV support (e.g., Protek Duo). In contrast, a low CPO (<0.6 W) 
with high PCWP and low CI suggests severe left ventricular failure, potentially 
responsive to Impella or tandem LV support. When profound biventricular failure or 
mixed shock exists, especially with systemic hypoxemia or lactic acidosis, veno-arterial 
extracorporeal membrane oxygenation (VA-ECMO) may be the most appropriate 
strategy [20]. Additionally, we aim to assess the frequency of PAC-related 
complications to better define its safety profile. 
Acknowledgments 
 
The authors would like to express their deepest gratitude to all patients and their 
families who consented to participate in this study. We sincerely thank our colleagues 
at the Emergency Center of Bach Mai Hospital and Hanoi Medical University for their 
exceptional collaboration, clinical support, and dedication to patient care. Special 
thanks are extended to the nurses, residents, and fellows who contributed to the 
continuous monitoring and management of hemodynamic parameters, as well as to the 
research coordination team for their meticulous data collection and adherence to 
protocol. No external funding was received for this study. The authors declare no 
conflicts of interest. 
 
 
Author Contributions 
Conceptualization: Tuan Anh Nguyen, Quan Nguyen Huu, Hung Tran Ha, Thang 
Pham Xuan. 
Data curation: Thang Pham Xuan, Tuan Anh Nguyen, Quan Nguyen Huu, Hung Tran 
Ha, Minh Duy Nguyen, Tu Nguyen Thanh, Dai Khuong Quoc, Linh Nguyen Quoc, Hieu 
Nguyen Minh, Nghia Nguyen Van, Dat Nguyen Tuan. 
Formal analysis: Thang Pham Xuan, Tuan Anh Nguyen, Quan Nguyen Huu, Hung 
Tran Ha. 
Funding acquisition: Thang Pham Xuan, Tuan Anh Nguyen, Quan Nguyen Huu, Minh 
Duy Nguyen, Thong Tran Huu. 
Investigation: Tuan Anh Nguyen, Quan Nguyen Huu, Linh Quoc Nguyen. 
Methodology: Thang Pham Xuan, Tuan Anh Nguyen, Quan Nguyen Huu. 
Project administration: Quan Nguyen Huu, Thang Pham Xuan, Dat Nguyen Tuan. 
Resources: Tuan Nguyen Anh, Thang Pham Xuan, Quan Nguyen Huu 
Software: Hieu Nguyen Minh, Nghia Nguyen Van, Tu Nguyen Thanh, Dai Khuong 
Quoc, Linh Nguyen Quoc. 
Supervision: Thong Tran Huu, Quan Nguyen Huu, Thang Pham Xuan, Minh Nguyen 
Duy, Linh Nguyen Quoc. 
Validation: Thang Pham Xuan, Minh Nguyen Duy. 
Writing – original draft: Thang Pham Xuan, Tuan Anh Nguyen, Quan Nguyen Huu, 
Hung Tran Ha, Dat Tuan Nguyen, Linh Nguyen Quoc. 
Writing – review & editing: Thang Pham Xuan, Tuan Anh Nguyen, Quan Nguyen 
Huu, Hung Tran Ha, Dat Tuan Nguyen, Linh Nguyen Quoc. 
 

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