Ignite Creation Date:
2024-06-16 @ 11:47 AM
Last Modification Date:
2024-10-26 @ 3:30 PM
Study NCT ID:
NCT06426407
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-23
First Post:
2024-02-16
Brief Title:
Vasopressin Hemodynamic Response as a Septic Shock Subphenotype Indicator
Sponsor:
The Cleveland Clinic
Organization:
The Cleveland Clinic
Study Overview
Official Title:
Vasopressin Hemodynamic Response as a Septic Shock Subphenotype Indicator
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 will be taken Participants who are not ordered the drug vasopressin and only ordered the drug norepinephrine will contribute only one sample At the time the sample is collected advanced echocardiography pictures will be taken This research also involves analyzing data obtained during the participants hospital stay
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
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 will be taken Participants who are not ordered the drug vasopressin and only ordered the drug norepinephrine will contribute only one sample At the time the sample is collected advanced echocardiography pictures will be taken This research also involves analyzing data obtained during the participants hospital stay
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 patients hemodynamic profile as assessed by echocardiography In the current study the investigators seek to clarify the link between vasopressin immune response and hemodynamic profile The central goal of this proposal is to identify vasopressin response as an easily-identifiable bedside indicator of a distinct septic shock subphenotype
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None