Septic ShockNCT07616817
Delphi Septic Shock: Sub-phenotypes Using Point-of-Care Ultrasound in Patients With Septic Shock
An observational study of Septic Shock and Sepsis, run by Albany Medical College at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Septic Shock, Sepsis, Shock
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Dec 2025to 1 Dec 2027
- How long will I take part?
- 3 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Child, Adult, Older adult
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.
Who may be able to join
- -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.
Who cannot join
- Expert candidates who do not meet detailed inclusion criteria
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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.
Read the 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
- 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.
- To generate consensus position statements on the management of haemodynamic sub-phenotypes using point-of-care ultrasound in patients with septic shock.
- To identify research priorities for haemodynamic subphenotypes of septic shock.
- Conditions
- Septic Shock, Sepsis, Shock
- Keywords
- point-of-care ultrasound, delphi, hemodynamic management, echo phenotypes, septic shock, consensus, ultrasound, anesthesiology, critical care
- Medical subject headings
- Shock, Septic, Sepsis, Shock
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: through study completion, on average, 6 months.
Secondary outcomes (1)
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
Measured: through study completion, on average, 6 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2026
- Study start5 Dec 2025
- Primary completion1 Sep 2026 (estimated)
- Study completion1 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Septic ShockStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
- Target duration
- 3 Years
Sponsor and investigators
- Lead sponsor
- Albany Medical College
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nibras Bughrara, Albany Medical College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07616817
- Sponsor's protocol ID
- 7146
- Status last verified
- May 2026
- First submitted
- 19 May 2026
- Last updated
- 1 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Information collected will be de-identified and only over consensus results will be sought--not individual participant data.
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Consensus Statements on Classification and Management of Hemodynamic Sub-phenotypes Using Point-of-Care Ultrasound in Patients With Septic Shock
- ClinicalTrials.gov ID
- NCT07616817
- Acronym / sponsor ID
- 7146
- Conditions
- Septic Shock, Sepsis, Shock
- Keywords
- point-of-care ultrasound, delphi, hemodynamic management, echo phenotypes, septic shock, consensus, ultrasound, anesthesiology
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Albany Medical CollegeUniversity, hospital or other
- Study start
- 5 Dec 2025 (actual)
- Primary completion
- 1 Sep 2026 (estimated)
- Study completion
- 1 Dec 2027 (estimated)
- First posted
- 1 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- 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.
- To generate consensus position statements on the management of haemodynamic sub-phenotypes using point-of-care ultrasound in patients with septic shock.
- To identify research priorities for haemodynamic subphenotypes of septic shock.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 3 Years
Who may qualify
- Sex
- All
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (6 listed)
- -Healthcare professionals with at least 30% of the clinical work commitment to managing critically ill patients.
- 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.
Key exclusion criteria (1 listed)
- Expert candidates who do not meet detailed inclusion criteria
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Time frame: through study completion, on average, 6 months.
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.
1 secondary outcome
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.
Time frame: through study completion, on average, 6 months.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2026.
- Perioperative Management of Patients with Sepsis and Septic Shock, Part II: Ultrasound Support for Resuscitation.Link provided by the sponsor.
- Delphi methodology in healthcare research: How to decide its appropriatenessLink provided by the sponsor.
- Individual participant dataSharing planned: No. Information collected will be de-identified and only over consensus results will be sought--not individual participant data.
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Sepsis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Septic Shock and Sepsis, run by Albany Medical College at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 1 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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. (time frame: through study completion, on average, 6 months.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jun 2026.