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Renin Levels as Prognostic Indicators of Septic Shock Severity and Outcome

Recruiting
Conditions
Sepsis
Septic Shock
Interventions
Other: Analysis of plasma renin concentration
Registration Number
NCT06545838
Lead Sponsor
Federal Research and Clinical Centre of Intensive Care Medicine and Rehabilitology
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.

Detailed Description

Not available

Recruitment & Eligibility

Status
RECRUITING
Sex
All
Target Recruitment
50
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

Study & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Arm && Interventions
GroupInterventionDescription
Septic groupAnalysis of plasma renin concentrationPatients with sepsis or septic shock
Primary Outcome Measures
NameTimeMethod
Correlation between blood renin concentration and norepinephrine dosageThrough study completion, an average of 2 years

A correlation analysis with the calculation of the correlation strength. The degree of correlation ranges from 0 to 1. The closer the correlation coefficient is to one, the stronger the correlation.

Secondary Outcome Measures
NameTimeMethod
Correlation between blood renin concentration and blood procalcitonin concentrationThrough study completion, an average of 2 years

A correlation analysis with the calculation of the correlation strength. The degree of correlation ranges from 0 to 1. The closer the correlation coefficient is to one, the stronger the correlation.

Correlation between blood renin concentration and peripheral blood flowThrough study completion, an average of 2 years

A correlation analysis with the calculation of the correlation strength. The degree of correlation ranges from 0 to 1. The closer the correlation coefficient is to one, the stronger the correlation.

Correlation between blood renin concentration and SOFA scoreThrough study completion, an average of 2 years

A correlation analysis with the calculation of the correlation strength. The degree of correlation ranges from 0 to 1. The closer the correlation coefficient is to one, the stronger the correlation.

Correlation between blood renin concentration and renal replacement therapy free daysThrough study completion, an average of 2 years

A correlation analysis with the calculation of the correlation strength. The degree of correlation ranges from 0 to 1. The closer the correlation coefficient is to one, the stronger the correlation.

Correlation between blood renin concentration and blood lactate concentrationThrough study completion, an average of 2 years

A correlation analysis with the calculation of the correlation strength. The degree of correlation ranges from 0 to 1. The closer the correlation coefficient is to one, the stronger the correlation.

28-days mortality28 days

Number of deaths in period of 28 days after enrollment

Frequency of Major Adverse Kidney Events (MAKE)28 days

Count of individuals who experience any of the following: all-cause mortality, renal replacement therapy, and acute kidney injury

Trial Locations

Locations (1)

Federal Research and Clinical Center of Intensive Care Medicine and Rehabilitology

🇷🇺

Moscow, Russian Federation

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