Renin Levels as Prognostic Indicators of Septic Shock Severity and Outcome

NCT ID: NCT06545838

Last Updated: 2025-03-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-01-29

Study Completion Date

2027-07-20

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Sepsis Septic Shock

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Septic group

Patients with sepsis or septic shock

Analysis of plasma renin concentration

Intervention Type OTHER

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Analysis of plasma renin concentration

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

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Università Vita-Salute San Raffaele

OTHER

Sponsor Role collaborator

Federal Research and Clinical Centre of Intensive Care Medicine and Rehabilitology

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Valery Likhvantsev

MD, PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Valery Likhvantsev, PhD

Role: PRINCIPAL_INVESTIGATOR

Federal Research and Clinical Centre of Intensive Care Medicine and Rehabilitology

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Federal Research and Clinical Center of Intensive Care Medicine and Rehabilitology

Moscow, , Russia

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Russia

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Valery Likhvantsev, PhD

Role: CONTACT

+79036235982

Levan Berikashvili, PhD

Role: CONTACT

+79263308968

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Valery Likhvantsev, PhD

Role: primary

+79036235982

Levan Berikashvili, MD

Role: backup

+79263308968

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

SOS

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Diagnostic Accuracy in Sepsis
NCT03956043 COMPLETED