Vasopressin Hemodynamic Response as a Septic Shock Subphenotype Indicator

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Drug
Study Type: Observational
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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)

Locations
United States
Ohio
Cleveland Clinic Main Campus
ENROLLING_BY_INVITATION
Cleveland
Cleveland Clinic Main Campus
RECRUITING
Cleveland
Contact Information
Primary
Seth Bauer, PharmD
bauers@ccf.org
2169522553
Time Frame
Start Date: 2025-10-01
Estimated Completion Date: 2027-06
Participants
Target number of participants: 48
Treatments
Vasopressin plus norepinephrine
Patients with septic shock ordered vasopressin as an adjunct to norepinephrine
Norepinephrine
Active control cohort of patients with septic shock who are only receiving norepinephrine
Related Therapeutic Areas
Sponsors
Leads: The Cleveland Clinic

This content was sourced from clinicaltrials.gov