Clinical trial NCT06545838: Renin Levels as Prognostic Indicators of Septic Shock Severity and Outcome
Official title: Renin Levels as Prognostic Indicators of Septic Shock Severity and Outcome: Prospective Cohort Study (SOS Trial)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Sepsis
Septic Shock
Keywords: Sepsis
Septic shock
Renin
Lactate
Procalcitonin
Lead sponsor: Federal Research and Clinical Centre of Intensive Care Medicine and Rehabilitology
Sponsor class: OTHER
Collaborators: name: Università Vita-Salute San Raffaele
First posted: 2024-08-09
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with sepsis or septic shock

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.


Eligibility criteria: Inclusion Criteria:

* Age ≥ 18 years
* Hospitalization in the intensive care unit
* Confirmed diagnosis of Sepsis within 24 hours
* Signed informed consent or a decision by the medical council to include the patient in the study

Exclusion Criteria:

* Any surgical intervention on the kidneys and/or adrenal glands performed within 28 days prior to the patient's inclusion in the study
* Patients previously included in this study

Primary outcomes:
measure: Correlation between blood renin concentration and norepinephrine dosage
timeFrame: Through study completion, an average of 2 years
Secondary outcomes:
measure: Correlation between blood renin concentration and blood procalcitonin concentration
timeFrame: Through study completion, an average of 2 years
measure: Correlation between blood renin concentration and peripheral blood flow
timeFrame: Through study completion, an average of 2 years
measure: Correlation between blood renin concentration and SOFA score
timeFrame: Through study completion, an average of 2 years
measure: Correlation between blood renin concentration and renal replacement therapy free days
timeFrame: Through study completion, an average of 2 years
measure: 28-days mortality
timeFrame: 28 days
measure: Frequency of Major Adverse Kidney Events (MAKE)
timeFrame: 28 days
measure: Correlation between blood renin concentration and blood lactate concentration
timeFrame: Through study completion, an average of 2 years
Other outcomes:
Locations:
city: Moscow
country: Russian Federation
facility: Federal Research and Clinical Center of Intensive Care Medicine and Rehabilitology
Study officials:
affiliation: Federal Research and Clinical Centre of Intensive Care Medicine and Rehabilitology
name: Valery Likhvantsev, PhD
role: PRINCIPAL_INVESTIGATOR
References: