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NCT Number: NCT06545838

Renin Levels as Prognostic Indicators of Septic Shock Severity and Outcome

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Federal Research and Clinical Center of Intensive Care Medicine and Rehabilitology

Moscow, Russia

Location status: Recruiting

Location contact

Ivan Kuznetsov, MD

SUB_INVESTIGATOR

Levan Berikashvili, MD

CONTACT

[email protected]

+79263308968

Levan Berikashvili, MD

SUB_INVESTIGATOR

Valery Likhvantsev, PhD

CONTACT

[email protected]

+79036235982

Valery Likhvantsev, PhD

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Analysis of plasma renin concentration

Other

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

Primary outcomes

  1. Correlation between blood renin concentration and norepinephrine dosage

    Time frame: Through 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 outcomes

  1. Correlation between blood renin concentration and blood procalcitonin concentration

    Time frame: Through 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.

  2. Correlation between blood renin concentration and peripheral blood flow

    Time frame: Through 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.

  3. Correlation between blood renin concentration and SOFA score

    Time frame: Through 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.

  4. Correlation between blood renin concentration and renal replacement therapy free days

    Time frame: Through 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.

  5. 28-days mortality

    Time frame: 28 days

    Number of deaths in period of 28 days after enrollment

  6. Frequency of Major Adverse Kidney Events (MAKE)

    Time frame: 28 days

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

  7. Correlation between blood renin concentration and blood lactate concentration

    Time frame: Through 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Levan Berikashvili, PhD

CONTACT

[email protected]

+79263308968

Valery Likhvantsev, PhD

CONTACT

[email protected]

+79036235982

Sponsors and collaborators

Lead sponsor

Federal Research and Clinical Centre of Intensive Care Medicine and Rehabilitology

Other

Collaborators

  • Università Vita-Salute San Raffaele

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Aug 9, 2024
Registry last updated
Mar 12, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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