Ignite Creation Date:
2024-10-26 @ 3:37 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06545838
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-06
Brief Title:
Renin Levels as Prognostic Indicators of Septic Shock Severity and Outcome
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Renin Levels as Prognostic Indicators of Septic Shock Severity and Outcome Prospective Cohort Study SOS Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The Surviving Sepsis Campaign SSC of 2021 characterizes sepsis as a life-threatening organ dysfunction caused by a dysregulated host response to infection with a mortality rate of over 30 which increases to 40 or more in the case of septic shock Although concept of sepsis has improved significant gaps remain in assessing its clinical severity and predicting patient outcomes
Recognized markers of the severity of septic shock are procalcitonin PCT presepsin and to a certain extent lactate Elevated lactate levels result from a shift to anaerobic glycolysis and indicate inadequate oxygen delivery to tissues Despite the importance of procalcitonin in the course of sepsis it has proven to be a suboptimal diagnostic biomarker for the development of sepsis with sensitivity and specificity below 80 As a result the use of procalcitonin in addition to clinical assessment to determine the indications for initiating antibiotic therapy is not recommended Meanwhile presepsin although a potential biomarker for the early diagnosis of sepsis also has only moderate accuracy according to current data and cannot be used as the only test for the diagnosis of sepsis
Renin is a crucial enzyme in the renin-angiotensin-aldosterone system RAAS which plays an important role in the regulation of blood pressure tissue perfusion and the balance of water and electrolytes Thus renin may be the sensitive biomarker with good prognostic qualities in the context of sepsis and septic shock Preliminary studies have indicated that elevated renin levels may act as an indicator of patient severity and could also be used as a marker for the development of septic shock and mortality prognosis
This study aims to address these gaps by investigating the role of renin as a biomarker for the severity of sepsis and septic shock focusing on its potential for more accurate prediction of clinical outcomes
Recognized markers of the severity of septic shock are procalcitonin PCT presepsin and to a certain extent lactate Elevated lactate levels result from a shift to anaerobic glycolysis and indicate inadequate oxygen delivery to tissues Despite the importance of procalcitonin in the course of sepsis it has proven to be a suboptimal diagnostic biomarker for the development of sepsis with sensitivity and specificity below 80 As a result the use of procalcitonin in addition to clinical assessment to determine the indications for initiating antibiotic therapy is not recommended Meanwhile presepsin although a potential biomarker for the early diagnosis of sepsis also has only moderate accuracy according to current data and cannot be used as the only test for the diagnosis of sepsis
Renin is a crucial enzyme in the renin-angiotensin-aldosterone system RAAS which plays an important role in the regulation of blood pressure tissue perfusion and the balance of water and electrolytes Thus renin may be the sensitive biomarker with good prognostic qualities in the context of sepsis and septic shock Preliminary studies have indicated that elevated renin levels may act as an indicator of patient severity and could also be used as a marker for the development of septic shock and mortality prognosis
This study aims to address these gaps by investigating the role of renin as a biomarker for the severity of sepsis and septic shock focusing on its potential for more accurate prediction of clinical outcomes
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None