An observational study in Septic Shock, Sepsis and Shock, sponsored by Albany Medical College. Enrolling by invitation at 1 site in United States. Per ClinicalTrials.gov, last updated 2026-06-01.
Sponsored by Albany Medical College · Observational
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.
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
1,078 studies on the registry are indexed under Shock, Septic; 232 are open to participants now.
This study's planned enrollment of 50 is below the median of 108 across 406 observational studies indexed under Shock, Septic.
Browse Shock, Septic studies →Albany Medical College is the lead sponsor of 81 studies on the registry; 14 are open to participants now.
Of its 17 completed or terminated interventional studies of FDA-regulated products, 3 (18%) have results posted.
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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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
-Healthcare professionals with at least 30% of the clinical work commitment to managing critically ill patients.
AND at least one of the following:
Exclusion Criteria:
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.
Time frame: through study completion, on average, 6 months.
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
Time frame: through study completion, on average, 6 months.
Plan to share: No — Information collected will be de-identified and only over consensus results will be sought--not individual participant data.
Started Dec 2025 (actual). Primary completion is estimated for Sep 2026, 8 months after the start.
Of 189 non-industry observational studies under Shock, Septic, half reached primary completion within 25 months of starting (the median), counting those still running; a quarter within 13 and three quarters within 47. This study's planned 8 months is below that.
Counting every sponsor, half of 202 studies reached it within 25 months; a quarter within 12 and three quarters within 47.
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Albany Medical College