Delphi Septic Shock: Sub-phenotypes Using Point-of-Care Ultrasound in Patients With Septic Shock

Consensus Statements on Classification and Management of Hemodynamic Sub-phenotypes Using Point-of-Care Ultrasound in Patients With Septic Shock

The Delphi survey process is a well-established mechanism for generating consensus on a certain topic by using a panel "collective intelligence". The Steering Committee, made up of critical care physicians, will undertake a literature search on available information, including existing hemodynamic sub-phenotypes and the use of point-of-care ultrasound in the classification and management of septic shock. The Steering Committee will not participate in the Delphi surveys. The anonymity of the Experts will be maintained until the end of the Delphi rounds. Point-of-care ultrasound has been proposed as a quick bed-side tool to identify hemodynamic subphenotypes and may guide personalized management. However, there is a dearth of evidence supporting the presence of these subphenotypes and management recommendations (if any) based on these subphenotypes. Thus, the objective of this study would be to conduct a survey, using the Delphi method, to obtain a consensus from critical care experts on classification and management of hemodynamic cardiac and lung phenotypes.

Study Overview

• Status: Enrolling by invitation
• Conditions: Sepsis; Shock; Septic Shock

Detailed Description

Purpose:

This study proposes a modified Delphi-based approach to generate expert's consensus statements on the classification and the management of hemodynamic sub-phenotypes using point-of-care ultrasound and clinical assessment of patients with septic shock.

The pathophysiology of septic shock involves alterations in volume dynamics, involving macro and microcirculation. Sepsis-induced cardiomyopathy, characterized by a global decrease in LV ejection fraction (LVEF) of less than 50% or a 10% drop from baseline, affects 40-50% of individuals with septic shock. At least in one explorational study, myocardial dysfunction was prevalent in all patients with septic shock when considering left ventricle (LV) systolic and diastolic, right ventricular (RV), and mixed failure. The presence of underlying chronic cardiac disease can further complicate hemodynamic presentation and management of patients with sepsis. Sepsis and pre-existing heart failure (HF) together worsen clinical outcomes due to the compounding effects of both conditions. Reciprocally, sepsis-induced cardiomyopathy can further worsen cardiac performance in patients with HF. This interplay highlights the need for tailored therapeutic strategies to address the dual burden of these conditions.

Additionally, many hemodynamic measurements previously used lack accuracy when applied to patients with sepsis. In 2016 guidelines, the Surviving Sepsis Campaign removed central venous pressure (CVP) assessment due to its limited ability to predict volume status within the normal range of 8 to 12 mm Hg, as this static hemodynamic measure is predictive of response to fluid administration only at extreme ranges. In patients with sepsis and pre-existing HF, CVP is even less accurate, as preload estimates depend on ventricular compliance. Right ventricular (RV) dysfunction can elevate CVP, while left ventricular (LV) dysfunction and pulmonary edema may have minimal impact. Similarly, the accuracy of pulse pressure variation (PPV) may be reduced by RV dysfunction or LV dysfunction, with the effects most pronounced in RV failure due to pulmonary hypertension.

Point-of-care ultrasound has been proposed as a quick bed-side tool to identify hemodynamic subphenotypes and may guide personalized management. However, there is a dearth of evidence supporting the presence of these subphenotypes and management recommendations (if any) based on these subphenotypes. We propose a modified Delphi-based approach to generate expert's consensus statements on the classification and the management of haemodynamic sub-phenotypes using point-of-care ultrasound and clinical assessment of patients with septic shock.

OBJECTIVES

1. To generate consensus position statements on the classification of haemodynamic sub-phenotypes using point-of-care ultrasound and clinical assessment of patients with septic shock.
2. To generate consensus position statements on the management of haemodynamic sub-phenotypes using point-of-care ultrasound in patients with septic shock.
3. To identify research priorities for haemodynamic subphenotypes of septic shock.

• Study Type: Observational
• Enrollment (Estimated): 50

Contacts and Locations

Study Locations

• United States
  • New York
    • Albany, New York, United States, 12208
      • Albany Medical College

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

Study Population

Steering Committee A world-wide Steering Committee (SC) comprised of critical care physicians with expertise in point-of-care ultrasound was formed including one Delphi methodologist.

Selection of Experts Healthcare professionals with at least 30% of the clinical work commitment to managing critically ill patients.

Description

Inclusion Criteria:

-Healthcare professionals with at least 30% of the clinical work commitment to managing critically ill patients.

AND at least one of the following:

• At least one publication on point-of-care ultrasound in critically ill patients
• Accreditation/certification/ institutional credentialing in point-of-care ultrasound or echocardiography.
• Ten or more years of experience in point-of-care ultrasonography in critically ill patients. 35-50 International experts from six continents will be engaged in the Delphi process.
• Concerted efforts will be made to ensure that at least 50% of the experts are from low-and middle-income countries and not more than 70% are from each sex.

Exclusion Criteria:

• Expert candidates who do not meet detailed inclusion criteria

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of agreement on statements in Delphi rounds on the classification of hemodynamic sub-phenotypes using point-of-care ultrasound in patients with septic shock.	To generate consensus position statements on the classification of hemodynamic sub-phenotypes using point-of-care ultrasound and clinical assessment of patients with septic shock--based on percentage of agreement of the statements.	through study completion, on average, 6 months.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of agreement on statements in Delphi rounds on the management of hemodynamic sub-phenotypes using point-of-care ultrasound in patients with septic shock.	To generate consensus position statements on the management of hemodynamic sub-phenotypes using point-of-care ultrasound in patients with septic shock	through study completion, on average, 6 months.

Collaborators and Investigators

• Sponsor: Albany Medical College

Publications and helpful links

Helpful Links

• Perioperative Management of Patients with Sepsis and Septic Shock, Part II: Ultrasound Support for Resuscitation.
• Delphi methodology in healthcare research: How to decide its appropriateness

Study record dates

Study Major Dates

• Study Start (Actual): December 5, 2025
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): December 1, 2027

Study Registration Dates

• First Submitted: May 19, 2026
• First Submitted That Met QC Criteria: May 23, 2026
• First Posted (Actual): June 1, 2026

Study Record Updates

• Last Update Posted (Actual): June 1, 2026
• Last Update Submitted That Met QC Criteria: May 23, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: septic shock; critical care; ultrasound; hemodynamic management; anesthesiology; consensus; point-of-care ultrasound; delphi; echo phenotypes
• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathological Conditions, Signs and Symptoms; Sepsis; Shock; Shock, Septic
• Other Study ID Numbers: 7146 (CTEP)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Information collected will be de-identified and only over consensus results will be sought--not individual participant data.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No