Ignite Creation Date:
2024-05-06 @ 6:53 PM
Last Modification Date:
2024-10-26 @ 2:56 PM
Study NCT ID:
NCT05824767
Status:
RECRUITING
Last Update Posted:
2024-07-12
First Post:
2023-03-05
Brief Title:
Serum Biomarkers to Predict Response to Angiotensin II in Septic Shock
Sponsor:
University of New Mexico
Organization:
University of New Mexico
Study Overview
Official Title:
DPP3 Angiotensin II and Renin Kinetics in Sepsis DARK-Sepsis Pilot Serum Biomarkers to Predict Response to Angiotensin II vs Standard-of-care Vasopressor Therapy in the Treatment of Septic Shock a Randomized Controlled Pilot Trial
Status:
RECRUITING
Status Verified Date:
2024-07
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:
DARK-Sepsis
Brief Summary:
This trial will be a randomized controlled single-center pilot trial comparing the use of angiotensin II versus standard-of-care SOC vasopressor therapy in adult patients with persistent vasodilatory shock despite moderate-dose norepinephrine with a primary outcome of the ability of novel biomarkers renin and DPP3 to predict blood pressure response to angiotensin II Given our angiotensin II will be compared to SOC this will be an unblinded study
Detailed Description:
Sepsis affects 1 million Americans yearly and when septic shock ensues it is associated with high morbidity and mortality Though first-line norepinephrine is standard of care there are limited prospective data to guide the choice of additional vasopressors in septic shock While more studies are needed preliminary data suggest that the vasopressor angiotensin II AngII may improve outcomes in septic shock especially in certain subsets of patients such as those with acute kidney injury AKI requiring renal replacement therapy RRT acute respiratory distress syndrome ARDS or high severity of illness
Furthermore there are no validated biomarkers currently available to guide the choice of vasopressor therapy in septic shock In this study the investigators will evaluate two potential biomarkers renin and dipeptidyl peptidase 3 DPP3 Renin has been shown in preliminary studies to accurately predict mortality in septic shock outperforming lactate and to predict beneficial response to AngII A less well-known candidate biomarker is DPP3 which is an aminopeptidase that cleaves a variety of biologically active oligopeptides including angiotensin II Similar to renin preliminary observational data show that elevated DPP3 levels in patients with sepsis are associated with organ dysfunction and short-term mortality outperforming lactate as a predictor of death
This study is an unblinded pilot randomized controlled trial RCT comparing AngII intervention to standard-of-care SOC vasopressor therapy in adult patients with persistent vasodilatory shock requiring moderate dose norepinephrine The primary outcome will be the ability of renin and DPP3 to predict blood pressure BP response to AngII As both renin and DPP3 are associated with overall short-term prognosis in sepsis the SOC arm will allow us to determine if the predictive value of renin and DPP3 is specific to AngII therapy A variety of secondary clinical outcomes will also be tracked but the primary purpose of this pilot study is to inform the future design of a large multicenter RCT evaluating the biomarker-guided use of angiotensin II as a second-line vasopressor in septic shock
Furthermore there are no validated biomarkers currently available to guide the choice of vasopressor therapy in septic shock In this study the investigators will evaluate two potential biomarkers renin and dipeptidyl peptidase 3 DPP3 Renin has been shown in preliminary studies to accurately predict mortality in septic shock outperforming lactate and to predict beneficial response to AngII A less well-known candidate biomarker is DPP3 which is an aminopeptidase that cleaves a variety of biologically active oligopeptides including angiotensin II Similar to renin preliminary observational data show that elevated DPP3 levels in patients with sepsis are associated with organ dysfunction and short-term mortality outperforming lactate as a predictor of death
This study is an unblinded pilot randomized controlled trial RCT comparing AngII intervention to standard-of-care SOC vasopressor therapy in adult patients with persistent vasodilatory shock requiring moderate dose norepinephrine The primary outcome will be the ability of renin and DPP3 to predict blood pressure BP response to AngII As both renin and DPP3 are associated with overall short-term prognosis in sepsis the SOC arm will allow us to determine if the predictive value of renin and DPP3 is specific to AngII therapy A variety of secondary clinical outcomes will also be tracked but the primary purpose of this pilot study is to inform the future design of a large multicenter RCT evaluating the biomarker-guided use of angiotensin II as a second-line vasopressor in septic shock
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None