NCT06426407·Not applicable·OBSERVATIONAL

Vasopressin Hemodynamic Response as a Septic Shock Subphenotype Indicator

Vasopressin Other Terminated

Status

Terminated

Phase

Not applicable

Enrollment

Locations

Results

Not posted

Publications

Study summary

What the protocol is testing.

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.

Full 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.

Interventions

Treatment arms and agents.

DRUG

Vasopressin

Fixed dosage vasopressin ordered as an adjunctive vasopressor to norepinephrine

Timeline

From registration to results.

First posted
May 23, 2024
Study start
Oct 1, 2025
Primary completion
Feb 1, 2026
Study completion
Feb 1, 2026
Results posted
Not reported
Registry updated
Feb 19, 2026

Outcomes

What the study measures.

Primary outcomes

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.

Secondary outcomes

Left ventricular ejection fraction (LVEF)

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

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.

Ratio of ratio of arterial elastance (Ea) to left ventricular end-systolic elastance (Ees)