Renin Levels as Prognostic Indicators of Septic Shock Severity and Outcome
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Analysis of plasma renin concentration.
- Who it may be relevant to
- Registry conditions: Sepsis, Septic Shock. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Russia
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Renin Levels as Prognostic Indicators of Septic Shock Severity and Outcome: Prospective Cohort Study (SOS Trial)
Overview
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.
Interventions
- Other Analysis of plasma renin concentration
The concentration of plasma renin in patients will be assessed using the immunochemiluminescent method
Primary outcome measures
- Correlation between blood renin concentration and norepinephrine dosage [Time frame: Through study completion, an average of 2 years]
Secondary outcome measures (7)
- Correlation between blood renin concentration and blood procalcitonin concentration [Time frame: Through study completion, an average of 2 years]
- Correlation between blood renin concentration and peripheral blood flow [Time frame: Through study completion, an average of 2 years]
- Correlation between blood renin concentration and SOFA score [Time frame: Through study completion, an average of 2 years]
- Correlation between blood renin concentration and renal replacement therapy free days [Time frame: Through study completion, an average of 2 years]
- 28-days mortality [Time frame: 28 days]
- Frequency of Major Adverse Kidney Events (MAKE) [Time frame: 28 days]
- Correlation between blood renin concentration and blood lactate concentration [Time frame: Through study completion, an average of 2 years]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Russia · 1 center
- Federal Research and Clinical Center of Intensive Care Medicine and Rehabilitology — Moscow
Identifiers
NCT: NCT06545838 · SOS