Renin Levels as Prognostic Indicators of Septic Shock Severity and Outcome

NCT06545838 | Recruiting DMC

• 1 other identifier: SOS
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Sepsis; Septic Shock

Keywords

Sepsis; Septic shock; Renin; Lactate; Procalcitonin

Outcome Measures

Primary Outcomes (1)

• Correlation between blood renin concentration and norepinephrine dosage

  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.

  Through study completion, an average of 2 years

Secondary Outcomes (7)

• Correlation between blood renin concentration and blood procalcitonin concentration

  Through study completion, an average of 2 years

• Correlation between blood renin concentration and peripheral blood flow

  Through study completion, an average of 2 years

• Correlation between blood renin concentration and SOFA score

  Through study completion, an average of 2 years

• Correlation between blood renin concentration and renal replacement therapy free days

  Through study completion, an average of 2 years

• 28-days mortality

  28 days

Study Arms (1)

Septic group

Patients with sepsis or septic shock

Other: Analysis of plasma renin concentration

Interventions

Analysis of plasma renin concentration OTHER

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

Septic group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with sepsis or septic shock

You may qualify if:

• 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

You may not qualify if:

• Patients previously included in this study

Sponsors & Collaborators

• Federal Research and Clinical Centre of Intensive Care Medicine and Rehabilitology: lead
• Università Vita-Salute San Raffaele: collaborator

Study Sites (1)

Federal Research and Clinical Center of Intensive Care Medicine and Rehabilitology

Moscow, Russia

RECRUITING

MeSH Terms

Conditions

Sepsis; Shock, Septic

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Shock

Study Officials

• Valery Likhvantsev, PhD

  Federal Research and Clinical Centre of Intensive Care Medicine and Rehabilitology

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Valery Likhvantsev, PhD

CONTACT

+79036235982; lik0704@gmail.com

Levan Berikashvili, PhD

CONTACT

+79263308968; levan.berikashvili@mail.ru

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: August 6, 2024
• First Posted: August 9, 2024
• Study Start: January 29, 2025
• Primary Completion (Estimated): August 20, 2026
• Study Completion (Estimated): July 20, 2027
• Last Updated: March 12, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

RU (1)