Vasopressin Hemodynamic Response as a Septic Shock Subphenotype Indicator

NCT06426407 | Terminated

• 1 other identifier: 21-047
• Study Type: observational
• Target: 2
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Shock, Septic

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline (before vasopressin initiation and within 45 minutes of order placement).

Secondary Outcomes (8)

• Left ventricular ejection fraction (LVEF)

  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)

  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

  Baseline (before vasopressin initiation and within 45 minutes of order placement) through one to six hours after vasopressin initiation.

• Monocyte adhesion

  Baseline (before vasopressin initiation and within 45 minutes of order placement) through one to six hours after vasopressin initiation.

• Plasma renin concentration

  Baseline (before vasopressin initiation and within 45 minutes of order placement) through one to six hours after vasopressin initiation.

Other Outcomes (23)

• Plasma interleukin-1β (IL-1β) concentration

  Baseline (before vasopressin initiation and within 45 minutes of order placement) through one to six hours after vasopressin initiation.

• Plasma interleukin-6 (IL-6) concentration

  Baseline (before vasopressin initiation and within 45 minutes of order placement) through one to six hours after vasopressin initiation.

• Plasma interferon-gamma (IFN-γ) concentration

  Baseline (before vasopressin initiation and within 45 minutes of order placement) through one to six hours after vasopressin initiation.

Study Arms (2)

Vasopressin plus norepinephrine

Patients with septic shock ordered vasopressin as an adjunct to norepinephrine

Drug: Vasopressin

Norepinephrine

Active control cohort of patients with septic shock who are only receiving norepinephrine

Interventions

Vasopressin DRUG

Fixed dosage vasopressin ordered as an adjunctive vasopressor to norepinephrine

Also known as: antidiuretic hormone (ADH), arginine vasopressin (AVP)

Vasopressin plus norepinephrine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• The Cleveland Clinic: lead

Study Sites (1)

Cleveland Clinic Main Campus

Cleveland, Ohio, 44195, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood collected into EDTA test tubes

MeSH Terms

Conditions

Shock, Septic

Interventions

Vasopressins; Arginine Vasopressin

Condition Hierarchy (Ancestors)

Sepsis; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Shock

Intervention Hierarchy (Ancestors)

Pituitary Hormones, Posterior; Pituitary Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Oligopeptides; Nerve Tissue Proteins; Proteins

Study Officials

• Seth Bauer, PharmD

  The Cleveland Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 16, 2024
• First Posted: May 23, 2024
• Study Start: October 1, 2025
• Primary Completion: February 1, 2026
• Study Completion: February 1, 2026
• Last Updated: February 19, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Study data will become available at the time of initial manuscript publication and remain available for 5 years after initial manuscript publication.
• Access Criteria: Individual participant data may be available through reasonable request to the study principal investigator and completion of a data use agreement.

Locations

US (1)