Shock, SepticNCT06426407

Vasopressin Hemodynamic Response as a Septic Shock Subphenotype Indicator

An observational study of Shock, Septic, run by The Cleveland Clinic at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Trial summary

The goal of this observational study is to learn about blood pressure response to the vasopressor drug vasopressin in people with septic shock. The main questions it aims to answer are: Are the levels of molecules showing communication between cells different between people whose blood pressure improves and people… Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Shock, Septic
What is being tested?: Vasopressin
How many people: 2 participants
Where: 1 siteUnited States
Study dates: 1 Oct 2025to 1 Feb 2026
Phase: Observational
Are there results?: None posted in the registry

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 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Study population: Adult patients with septic shock are eligible for this study. Patients ordered vasopressin as an adjunct to norepinephrine as part of routine care comprise the primary cohort of interest. An active control cohort of patients who are only receiving norepinephrine will also be enrolled.

Who may be able to join

Adult patients (≥18 years old)
Septic shock (as defined by Sepsis-3)
Receiving norepinephrine
Admitted to a medical, surgical, NeuroSciences, or mixed intensive care unit
Central venous catheter in place
Ordered fixed-dose vasopressin as an adjunct to norepinephrine by the primary care team (unless in active control cohort)

Who cannot join

Vasopressin ordered for an indication other than septic shock
Vasopressin initiated at another institution
Receiving a primary vasopressor other than norepinephrine (eg, phenylephrine)
Positive test for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) within the preceding 28 days
Blood hemoglobin concentration <7 g/dL
Primary treatment team determines that vasopressin initiation is emergent
Patient or their legal authorized representative opts to not participate in the study

Trial locations and contacts

1 site in 1 country.

United States1 site

Cleveland Clinic Main Campus
Cleveland, Ohio, 44195

Other trials in United States

About this study

The goal of this observational study is to learn about blood pressure response to the vasopressor drug vasopressin in people with septic shock.

The main questions it aims to answer are:

Are the levels of molecules showing communication between cells different between people whose blood pressure improves and people whose blood pressure does not improve when given a vasopressor medication?
Are measurements found on echocardiography (heart ultrasound) different between people whose blood pressure improves and people whose blood pressure does not improve when given a vasopressor medication?
Are measurements of blood oxygen in tissues just below the skin different between people whose blood pressure improves and people whose blood pressure does not improve when given a vasopressor medication?

Participants will be asked to contribute one or two blood samples. Participants who are ordered the drug vasopressin will contribute two blood samples. Both samples will be about two tablespoons for a total of about four tablespoons. One sample will be drawn before starting vasopressin infusion and the second sample will be drawn between one and six hours after starting the vasopressor drug infusion. At the same time points, advanced echocardiography pictures and measurements of oxygen in tissues from a sensor placed on one of the hands will be taken. Participants who are not ordered the drug vasopressin and only ordered the drug norepinephrine will contribute only one blood sample. At the time the sample is collected, advanced echocardiography pictures and measurements of oxygen in tissues from a sensor placed on one of the hands will be taken. This research also involves analyzing data obtained during the participant's hospital stay.

Read the detailed description

Septic shock mortality remains high at 33% in North America; current clinical predictors of poor outcomes in septic shock are suboptimal. In addition to antibiotics and intravenous fluids, vasoactive agents are initiated to restore effective tissue perfusion. Norepinephrine (NE) is the recommended first-line vasopressor, but adjunctive arginine vasopressin is used in over one-third of patients to improve blood pressure or decrease NE dosage. However, less than half of vasopressin recipients have a clinically-apparent hemodynamic response (defined as a decrease in NE dosage at 6 hours after vasopressin initiation). Vasopressors, particularly norepinephrine, are known to be immune modulators. Further, each vasopressor has its own unique effect on a patient's hemodynamic profile as assessed by echocardiography and microcirculation measurements. In the current study, the investigators seek to clarify the link between vasopressin, immune response, hemodynamic profile, and microcirculatory measurments. The central goal of this proposal is to identify "vasopressin response" as an easily-identifiable bedside indicator of a distinct septic shock subphenotype.

Conditions: Shock, Septic
Being tested: Vasopressin
Medical subject headings: Shock, Septic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

VasopressinDrug
Also called antidiuretic hormone (ADH), arginine vasopressin (AVP)
Fixed dosage vasopressin ordered as an adjunctive vasopressor to norepinephrine

Study groups in NCT06426407
Study group	Role	What they receive
Vasopressin plus norepinephrine		Patients with septic shock ordered vasopressin as an adjunct to norepinephrine Receives: Drug: Vasopressin
Norepinephrine		Active control cohort of patients with septic shock who are only receiving norepinephrine

What is being measured

The primary outcome is the main question the study is designed to answer.

Ratio of plasma interleukin-10 (IL-10) to tumor necrosis factor-α (TNF-α)
Compare baseline ratio of plasma concentrations of interleukin-10 (IL-10) to tumor necrosis factor-α (TNF-α) in vasopressin responders vs. non-responders. The active control cohort of patients who are only receiving norepinephrine will serve as a control for this analysis.
Measured: Baseline (before vasopressin initiation and within 45 minutes of order placement).

Secondary outcomes (8)

Left ventricular ejection fraction (LVEF)
Compare baseline left ventricular ejection fraction (LVEF) in vasopressin responders vs. non-responders. The active control cohort of patients who are only receiving norepinephrine will serve as a control for this analysis.
Measured: Baseline (before vasopressin initiation and within 45 minutes of order placement).
Ratio of ratio of arterial elastance (Ea) to left ventricular end-systolic elastance (Ees)
Compare left ventricular-arterial coupling (ratio of arterial elastance [Ea] to left ventricular end-systolic elastance [Ees]) over time in vasopressin responders vs. non-responders. The active control cohort of patients who are only receiving norepinephrine will serve as a control for this analysis.
Measured: Baseline (before vasopressin initiation and within 45 minutes of order placement) through one to six hours after vasopressin initiation.
Lipopolysaccharide-stimulated monocyte TNF-α secretion
Compare lipopolysaccharide-stimulated monocyte TNF-α secretion over time in vasopressin responders vs. non-responders. The active control cohort of patients who are only receiving norepinephrine will serve as a control for this analysis.
Measured: Baseline (before vasopressin initiation and within 45 minutes of order placement) through one to six hours after vasopressin initiation.
Monocyte adhesion
Compare monocyte adhesion over time in vasopressin responders vs. non-responders. The active control cohort of patients who are only receiving norepinephrine will serve as a control for this analysis.
Measured: Baseline (before vasopressin initiation and within 45 minutes of order placement) through one to six hours after vasopressin initiation.
Plasma renin concentration
Compare plasma renin concentration over time in vasopressin responders vs. non-responders. The active control cohort of patients who are only receiving norepinephrine will serve as a control for this analysis.
Measured: Baseline (before vasopressin initiation and within 45 minutes of order placement) through one to six hours after vasopressin initiation.
Plasma angiopoietin-2 concentration
Compare plasma angiopoietin-2 concentration over time in vasopressin responders vs. non-responders. The active control cohort of patients who are only receiving norepinephrine will serve as a control for this analysis.
Measured: Baseline (before vasopressin initiation and within 45 minutes of order placement) through one to six hours after vasopressin initiation.
StO2 recovery slope (%/min)
Compare tissue oxygenation (StO2) recovery slope, during the reperfusion phase of a vascular occlusion test (VOT), over time between vasopressin responders vs non-responders. The active control cohort of patients who are only receiving norepinephrine will serve as a control for this analysis.
Measured: Baseline (before vasopressin initiation and within 45 minutes of order placement) through one to six hours after vasopressin initiation.
Difference in StO2 (%)
Compare the difference between maximum tissue oxygenation (StO2) and minimum StO2, during the reperfusion phase of a vascular occlusion test (VOT), over time between vasopressin responders vs non-responders. The active control cohort of patients who are only receiving norepinephrine will serve as a control for this analysis.
Measured: Baseline (before vasopressin initiation and within 45 minutes of order placement) through one to six hours after vasopressin initiation.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Oct 20251 Feb 2026

First posted23 May 2024
Study start1 Oct 2025
Primary completion1 Feb 2026
Study completion1 Feb 2026

Why it stopped: The study was terminated due to lack of feasibility.

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Shock, SepticStudies of the same condition, open and under way.
More trials run by The Cleveland ClinicThe sponsor's other registered studies.
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: Cohort
Time perspective: Prospective
Enrolment: 2 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06426407
Sponsor's protocol ID: 21-047
Status last verified: Feb 2026
First submitted: 16 Feb 2024
Last updated: 19 Feb 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes: Individual participant data may be available through reasonable request to the study principal investigator and completion of a data use agreement.

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruitingObservational study
Serum GDF-15 and LGALS3BP as Prognostic Biomarkers in Sepsis
Sepsis, Septic Shock
RecruitingPhase 3
A Trial of Adjunctive Fludrocortisone (50mcg, 100mcg or Placebo) in Critically Ill Patients With Septic Shock Receiving Hydrocortisone, Evaluating Survival and Functional Recovery and the Influence of Transcriptomic Response
Septic Shock
Recruiting
Veno-arterial Carbon Dioxide Partial Pressure Difference (CO2gap) for Early Resuscitation of Septic Shock
Sepsis - to Reduce Mortality in the Intensive Care Unit, Septic Shock
Not yet recruiting
Hemodynamic Resuscitation Guided by Non-Invasive Mean Systemic Filling Pressure to Prevent Acute Kidney Injury in Septic Shock
Acute Kidney Injury Due to Sepsis
RecruitingObservational study
Clinical Value of EMR3 in Sepsis Diagnosis, Monitoring, and Prognosis: A Multicenter Prospective Observational Study
Sepsis

All Shock, Septic trials

Study at a glance

From the registry record, last updated by the sponsor on 19 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Vasopressin Hemodynamic Response as a Septic Shock Subphenotype Indicator
ClinicalTrials.gov ID: NCT06426407
Acronym / sponsor ID: 21-047
Conditions: Shock, Septic
Study type: Observational
Recruitment status: TerminatedReason stopped: The study was terminated due to lack of feasibility.
Enrolment: 2 participants (actual)
Lead sponsor: The Cleveland ClinicUniversity, hospital or other
Study start: 1 Oct 2025 (actual)
Primary completion: 1 Feb 2026 (actual)
Study completion: 1 Feb 2026 (actual)
First posted: 23 May 2024 (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 goal of this observational study is to learn about blood pressure response to the vasopressor drug vasopressin in people with septic shock.

The main questions it aims to answer are:

Are the levels of molecules showing communication between cells different between people whose blood pressure improves and people whose blood pressure does not improve when given a vasopressor medication?
Are measurements found on echocardiography (heart ultrasound) different between people whose blood pressure improves and people whose blood pressure does not improve when given a vasopressor medication?
Are measurements of blood oxygen in tissues just below the skin different between people whose blood pressure improves and people whose blood pressure does not improve when given a vasopressor medication?

Detailed description

Study design

Observational model: Cohort
Time perspective: Prospective
Number of arms: 2

Arm	Type	Receives
Vasopressin plus norepinephrine	–	Drug: VasopressinPatients with septic shock ordered vasopressin as an adjunct to norepinephrine
Norepinephrine	–	–Active control cohort of patients with septic shock who are only receiving norepinephrine

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: Adult patients with septic shock are eligible for this study. Patients ordered vasopressin as an adjunct to norepinephrine as part of routine care comprise the primary cohort of interest. An active control cohort of patients who are only receiving norepinephrine will also be enrolled.

Key inclusion criteria (6 listed)

Adult patients (≥18 years old)
Septic shock (as defined by Sepsis-3)
Receiving norepinephrine
Admitted to a medical, surgical, NeuroSciences, or mixed intensive care unit
Central venous catheter in place

Key exclusion criteria (7 listed)

Vasopressin ordered for an indication other than septic shock
Vasopressin initiated at another institution
Receiving a primary vasopressor other than norepinephrine (eg, phenylephrine)
Positive test for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) within the preceding 28 days
Blood hemoglobin concentration <7 g/dL

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
VasopressinAlso: antidiuretic hormone (ADH), arginine vasopressin (AVP)Fixed dosage vasopressin ordered as an adjunctive vasopressor to norepinephrine	Drug	Vasopressin plus norepinephrine

Primary outcome

Ratio of plasma interleukin-10 (IL-10) to tumor necrosis factor-α (TNF-α)
Time frame: Baseline (before vasopressin initiation and within 45 minutes of order placement).
Compare baseline ratio of plasma concentrations of interleukin-10 (IL-10) to tumor necrosis factor-α (TNF-α) in vasopressin responders vs. non-responders. The active control cohort of patients who are only receiving norepinephrine will serve as a control for this analysis.

8 secondary outcomes

Left ventricular ejection fraction (LVEF)
Time frame: Baseline (before vasopressin initiation and within 45 minutes of order placement).
Ratio of ratio of arterial elastance (Ea) to left ventricular end-systolic elastance (Ees)
Time frame: Baseline (before vasopressin initiation and within 45 minutes of order placement) through one to six hours after vasopressin initiation.
Lipopolysaccharide-stimulated monocyte TNF-α secretion
Time frame: Baseline (before vasopressin initiation and within 45 minutes of order placement) through one to six hours after vasopressin initiation.
Monocyte adhesion
Time frame: Baseline (before vasopressin initiation and within 45 minutes of order placement) through one to six hours after vasopressin initiation.
Plasma renin concentration
Time frame: Baseline (before vasopressin initiation and within 45 minutes of order placement) through one to six hours after vasopressin initiation.
Plasma angiopoietin-2 concentration
Time frame: Baseline (before vasopressin initiation and within 45 minutes of order placement) through one to six hours after vasopressin initiation.
StO2 recovery slope (%/min)
Time frame: Baseline (before vasopressin initiation and within 45 minutes of order placement) through one to six hours after vasopressin initiation.
Difference in StO2 (%)
Time frame: Baseline (before vasopressin initiation and within 45 minutes of order placement) through one to six hours after vasopressin initiation.

Results and safety

The study was stopped early (reason given: The study was terminated due to lack of feasibility.). Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 19 Feb 2026.
Individual participant dataSharing planned: Yes. Individual participant data may be available through reasonable request to the study principal investigator and completion of a data use agreement.

Related trials for Shock, Septic

Not yet recruitingObservational study
Serum GDF-15 and LGALS3BP as Prognostic Biomarkers in Sepsis
Sepsis, Septic Shock
RecruitingPhase 3
A Trial of Adjunctive Fludrocortisone (50mcg, 100mcg or Placebo) in Critically Ill Patients With Septic Shock Receiving Hydrocortisone, Evaluating Survival and Functional Recovery and the Influence of Transcriptomic Response
Septic Shock
Recruiting
Veno-arterial Carbon Dioxide Partial Pressure Difference (CO2gap) for Early Resuscitation of Septic Shock
Sepsis - to Reduce Mortality in the Intensive Care Unit, Septic Shock
Not yet recruiting
Hemodynamic Resuscitation Guided by Non-Invasive Mean Systemic Filling Pressure to Prevent Acute Kidney Injury in Septic Shock
Acute Kidney Injury Due to Sepsis
RecruitingObservational study
Clinical Value of EMR3 in Sepsis Diagnosis, Monitoring, and Prognosis: A Multicenter Prospective Observational Study
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. This study is not recruiting at the moment.

Seth Bauer, PharmD principal investigator

The Cleveland Clinic

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 Shock, Septic, run by The Cleveland Clinic 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 7 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: stopped early, as of the sponsor's last update on 19 Feb 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?

The study was stopped early (reason given: The study was terminated due to lack of feasibility.). Results are not available in the source record.

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?

Ratio of plasma interleukin-10 (IL-10) to tumor necrosis factor-α (TNF-α) (time frame: Baseline (before vasopressin initiation and within 45 minutes of order placement).). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06426407.

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 19 Feb 2026.