SepsisNCT06545838
Renin Levels as Prognostic Indicators of Septic Shock Severity and Outcome
An observational study of Sepsis and Septic Shock, run by Federal Research and Clinical Centre of Intensive Care Medicine and Rehabilitology at 1 site in Russia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sepsis, Septic Shock
- What is being tested?
- Analysis of plasma renin concentration
- How many people
- 50 participants
- Where
- 1 siteRussia
- Study dates
- 29 Jan 2025to 20 Jul 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with sepsis or septic shock
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Russia1 site, 1 recruiting
- Recruiting
Federal Research and Clinical Center of Intensive Care Medicine and Rehabilitology
Moscow
Valery Likhvantsev, PhD, +79036235982, lik0704@gmail.com
Levan Berikashvili, MD, +79263308968, levan.berikashvili@mail.ru
About this study
Official title: Renin Levels as Prognostic Indicators of Septic Shock Severity and Outcome: Prospective Cohort Study (SOS Trial)
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.
Read more
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
- Being tested
- Analysis of plasma renin concentration
- Keywords
- Sepsis, Septic shock, Renin, Lactate, Procalcitonin
- Medical subject headings
- Sepsis, Shock, Septic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Analysis of plasma renin concentrationOther
The concentration of plasma renin in patients will be assessed using the immunochemiluminescent method
| Study group | Role | What they receive |
|---|---|---|
| Septic group | Patients with sepsis or septic shock Receives: Other: Analysis of plasma renin concentration |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Through study completion, an average of 2 years
Secondary outcomes (7)
Correlation between blood renin concentration and blood procalcitonin concentration
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.
Measured: Through study completion, an average of 2 years
Correlation between blood renin concentration and peripheral blood flow
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.
Measured: Through study completion, an average of 2 years
Correlation between blood renin concentration and SOFA score
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.
Measured: Through study completion, an average of 2 years
Correlation between blood renin concentration and renal replacement therapy free days
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.
Measured: Through study completion, an average of 2 years
28-days mortality
Number of deaths in period of 28 days after enrollment
Measured: 28 days
Frequency of Major Adverse Kidney Events (MAKE)
Count of individuals who experience any of the following: all-cause mortality, renal replacement therapy, and acute kidney injury
Measured: 28 days
Correlation between blood renin concentration and blood lactate concentration
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.
Measured: Through study completion, an average of 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2024
- Study start29 Jan 2025
- Primary completion20 Aug 2026 (estimated)
- Study completion20 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SepsisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Federal Research and Clinical Centre of Intensive Care Medicine and Rehabilitology
- Sponsor type
- University, hospital or other
- Collaborators
- Università Vita-Salute San Raffaele
- Responsible party
- Principal investigator, Valery Likhvantsev, Federal Research and Clinical Centre of Intensive Care Medicine and Rehabilitology
- Investigators
- Valery Likhvantsev, PhD, Principal investigator, Federal Research and Clinical Centre of Intensive Care Medicine and Rehabilitology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06545838
- Sponsor's protocol ID
- SOS
- Status last verified
- Mar 2025
- First submitted
- 6 Aug 2024
- Last updated
- 12 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Renin Levels as Prognostic Indicators of Septic Shock Severity and Outcome: Prospective Cohort Study (SOS Trial)
- ClinicalTrials.gov ID
- NCT06545838
- Acronym / sponsor ID
- SOS
- Conditions
- Sepsis, Septic Shock
- Keywords
- Sepsis, Septic shock, Renin, Lactate, Procalcitonin
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Federal Research and Clinical Centre of Intensive Care Medicine and RehabilitologyUniversity, hospital or other
- Collaborators
- Università Vita-Salute San Raffaele
- Study start
- 29 Jan 2025 (actual)
- Primary completion
- 20 Aug 2026 (estimated)
- Study completion
- 20 Jul 2027 (estimated)
- First posted
- 9 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Septic group | – | Other: Analysis of plasma renin concentrationPatients with sepsis or septic shock |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with sepsis or septic shock
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Analysis of plasma renin concentrationThe concentration of plasma renin in patients will be assessed using the immunochemiluminescent method | Other | Septic group |
Primary outcome
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.
7 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Valery Likhvantsev, PhD principal investigator
Federal Research and Clinical Centre of Intensive Care Medicine and Rehabilitology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sepsis and Septic Shock, run by Federal Research and Clinical Centre of Intensive Care Medicine and Rehabilitology at 1 site in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 12 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Valery Likhvantsev, PhD (+79036235982, lik0704@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlation between blood renin concentration and norepinephrine dosage (time frame: Through study completion, an average of 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Mar 2025.