miRNA in Septic Acute Kidney Injury

June 1, 2026 updated by: University Hospital Ostrava

Specific miRNA Associated With Endothelial Dysfunction and Mitochondrial Damage in Patients With Septic Acute Kidney Injury

Acute kidney injury is a common and serious complication of sepsis and septic shock, which may be associated with a worse outcome of the patient's condition. The exact pathophysiological mechanism of septic acute kidney injury remains a challenge. One of the possible causes appears to be endothelial dysfunction and mitochondrial damage of renal tubular cells. The aim of this study is to identify specific microRNAs associated with these pathophysiological events in sepsis and septic acute kidney injury. And to establish a new potential diagnostic or therapeutic target for the prevention or treatment of septic acute kidney injury.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Sepsis is generally characterized as a life-threatening organ dysfunction and dysregulating host reaction to the infection (e.g., bacterial, viral, mycotic (1). Typical pathophysiological processes of sepsis include systemic inflammation, immune suppression, activation of the clotting cascade, and increase of endothelial vascular permeability with subsequent leak of fluids into the interstitial space. One of the most important organ damage due to ongoing sepsis is acute kidney injury (AKI), which is also a predictor of mortality in critically ill patients. The exact pathophysiology of septic AKI remains a challenging and poorly understood mechanism. A decrease of oxygen delivery to the tissues during the septic shock and usually high oxygen consumption of renal tubular cells make them prone to ischemia injury with consequences in tubular cell death. Among potential immune inflammatory response biomarkers in sepsis and septic shock might be promising pentraxin 3 (PTX3), which plays an important role in endothelial dysfunction with several pathogenic pathways' activation. Recently has been shown the positive effect of PTX3 on the inhibition of reactive oxygen species, mitochondrial injury, and apoptosis pathway in AKI (3,4). Another promising urinary or serum biomarker of AKI seems to be uromodulin, which is dynamically regulated in response to sepsis. Serum uromodulin concentrations decrease during septic human AKI development and are associated with increased renal and systemic oxidative damage (5,6,7). MicroRNAs are small non-coding RNAs, that have been reported to be useful biomarkers for AKI development or potential target for AKI treatment. Determination of serum PTX3 and uromodulin concomitantly with specific circulating miRNAs associated with PTX3 and uromodulin-specific signaling pathways in critically ill septic patients could bring new insights to septic AKI pathophysiology and contribute to future development of new preventive or therapeutic options in septic patients.

Study Type

Observational

Enrollment (Actual)

211

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Czechia
    • Moravian-Silesian Region
      • Ostrava, Moravian-Silesian Region, Czechia, 708 52
        • University Hospital Ostrava
    • Olomouc Region
      • Olomouc, Olomouc Region, Czechia, 779 00
        • University Hospital Olomouc

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

Critically ill adult patients suffering from sepsis defined according to SEPSIS 3 definition, with or without acute kidney injury defined by KDIGO 2012 (2) and healthy volunteers

Description

Inclusion Criteria:

The study group of patients with sepsis with or without acute kidney injury

  • age > 18 years
  • newly diagnosed sepsis or septic shock with or without acute kidney injury

Healthy volunteers

  • no evidence of infection on clinical or laboratory examination
  • age > 18 years
  • signed informed consent

Exclusion Criteria:

The study group of patients with sepsis with or without acute kidney injury

  • age < 18 years
  • chronic kidney disease at stage 4 or 5 according to KDIGO recommendations (KDIGO) for chronic kidney disease 2024
  • patients on chronic dialysis treatment, or after renal transplantation

Healthy volunteers

  • acute or chronic infection
  • renal disease

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Critically ill adult septic patients without acute kidney injury
The patients in this group will be screened clinically and by standard laboratory biochemical methods to determine sepsis diagnosis according to SEPSIS 3 (1). Blood samples for obtaining serum/plasma of the patients will be taken on the 1st and 4th day of sepsis diagnosis.
Diagnostic test: Laboratory examination to determine the presence of sepsis
Standard laboratory biochemical methods will be used to determine sepsis diagnosis accord-ing to SEPSIS 3 (1). Blood samples for obtaining serum/plasma of the patients will be taken on the 1st and 4th day of sepsis diagnosis.
Critically ill adult septic patients with acute kidney injury
The patients will be screened clinically and by standard laboratory biochemical methods to determine sepsis diagnosis according to SEPSIS 3 and acute kidney injury according to KDIGO 2012 (2). Blood samples for obtaining serum/plasma of the patients will be taken on the 1st and 4th day of sepsis diagnosis.
Diagnostic test: Laboratory examination to determine the presence of sepsis and acute kidney injury
Standard laboratory biochemical methods will be used to determine sepsis diagnosis according to SEPSIS 3 and acute kidney injury according to Guidelines Kidney Disease Improving Global Outcomes (KDIGO) 2012 (2). Blood samples for obtaining serum/plasma of the patients will be taken on the 1st and 4th day of sepsis diagnosis.
Healthy volunteers
The blood samples for miRNA and biochemical parameters will be collected once, after randomization.
Diagnostic test: Laboratory examination to determine miRNA and biochemical parameters
Laboratory examination will be performed to determine miRNA and biochemical parameters.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Determination of serum expression of pentraxin 3 (PTX3) and uromodulin
Time Frame: 4 days
To determine the concentration of serum PTX3 and serum uromodulin in critically ill septic patients and their comparison to serum concentrations of creatinine and the acute kidney injury (AKI) stage as well as to the concentrations of procalcitonin (PCT) and interleukin-6 (IL-6) as inflammation markers on day 1 and 4 of study. The serum concentrations of PTX3 and uromodulin in ng/mL will be determined also in healthy volunteers to establish the laboratory reference ranges (values).
4 days
Determination of expression and 4 days course investigation of miRNAs
Time Frame: 4 days
To determine the expression and 4-day time course investigation of 7 specific circulating miRNAs associated with sepsis and septic acute kidney injury from 352 miRNA targets using a two-tailed Quantitative reverse transcription polymerase chain reaction (RT-qPCR). All selected miRNAs will be determined also in healthy volunteers to establish the laboratory reference ranges (values).
4 days
Target genes of miRNAs and their association with endothelial dysfunction and mitochondrial injury in sepsis
Time Frame: 4 days
To match the target genes (from miRNA database) of these specifically expressed miRNAs with biochemical pathways associated with serum PTX3 and uromodulin involved in endothelial dysfunction of renal microvasculature, the influence of mitochondrial injury/dysfunction with reactive oxygen species production and activation of cell apoptosis in septic acute kidney injury.
4 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital Ostrava

Collaborators

University Hospital Olomouc

Investigators

  • Principal Investigator: Naděžda Petejová, Assoc.Prof.,MD,PhD,MSc, University Hospital Ostrava

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 2, 2024

Primary Completion (Actual)

March 31, 2026

Study Completion (Actual)

March 31, 2026

Study Registration Dates

First Submitted

June 27, 2024

First Submitted That Met QC Criteria

July 4, 2024

First Posted (Actual)

July 12, 2024

Study Record Updates

Last Update Posted (Actual)

June 3, 2026

Last Update Submitted That Met QC Criteria

June 1, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • INT-01-sepsis-miRNA
  • RVO-FNOs/2024 (Other Grant/Funding Number: University Hospital Ostrava)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

There is no plan to make individual participant data available to other researchers.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Sepsis

Clinical Trials on Laboratory examination to determine the presence of sepsis

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Philippines

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe