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Renin Levels as Prognostic Indicators of Septic Shock Severity and Outcome

Renin Levels as Prognostic Indicators of Septic Shock Severity and Outcome: Prospective Cohort Study (SOS Trial)

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06545838
Enrollment
50
Registered
2024-08-09
Start date
2025-01-29
Completion date
2027-07-20
Last updated
2025-03-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sepsis, Septic Shock

Keywords

Sepsis, Septic shock, Renin, Lactate, Procalcitonin

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.

Interventions

OTHERAnalysis of plasma renin concentration

The concentration of plasma renin in patients will be assessed using the immunochemiluminescent method

Sponsors

Università Vita-Salute San Raffaele
CollaboratorOTHER
Federal Research and Clinical Centre of Intensive Care Medicine and Rehabilitology
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Correlation between blood renin concentration and norepinephrine dosageThrough study completion, an average of 2 yearsA 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

MeasureTime frameDescription
Correlation between blood renin concentration and peripheral blood flowThrough study completion, an average of 2 yearsA 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 yearsA 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 yearsA 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 procalcitonin concentrationThrough study completion, an average of 2 yearsA 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.
Frequency of Major Adverse Kidney Events (MAKE)28 daysCount of individuals who experience any of the following: all-cause mortality, renal replacement therapy, and acute kidney injury
Correlation between blood renin concentration and blood lactate concentrationThrough study completion, an average of 2 yearsA 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 daysNumber of deaths in period of 28 days after enrollment

Countries

Russia

Contacts

Primary ContactValery Likhvantsev, PhD
lik0704@gmail.com+79036235982
Backup ContactLevan Berikashvili, PhD
levan.berikashvili@mail.ru+79263308968

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026