Specific miRNAs in Sepsis and Nephrotoxic Antibiotic Treatment

NCT04991376 | Completed

• 2 other identifiers: IK-01-miRNA01 - RVO - FNOs/2019
• Study Type: observational
• Target: 53
• Locations: 1 country
• Sites: 1

Brief Summary

Critically ill patients are prone to develop acute kidney injury due to sepsis itself and by administration of potentially nephrotoxic antibiotic treatment (vancomycin or gentamicin). Blood-specific miRNA levels associated with renal tubular damage change in patients treated with vancomycin or gentamicin compared to septic patients treated with other antimicrobials.

Conditions

Sepsis; Septic Shock; Acute Kidney Injury

Keywords

sepsis; septic shock; acute kidney injury; microRNA; nephrotoxicity; vancomycin; gentamicin

Outcome Measures

Primary Outcomes (1)

• miRNAs expression over 7 days of treatment

  Determine and investigate specific circulating miRNAs linked to sepsis itself, septic, ischemic, or nephrotoxic acute kidney injury in patients suffered from sepsis. Tracking changes in miRNAs expression over 7 days of treatment with nephrotoxic (vancomycin or gentamicin) as compared with other, non-nephrotoxic antibiotic treatment.

  7 days

Secondary Outcomes (1)

• Association between circulating miRNA expression and serum neutrophil gelatinase-associated lipocalin (NGAL) and other renal or inflammatory markers

  7 days

Study Arms (3)

Vancomycin

Critically ill patients who suffered from sepsis, treated with vancomycin.

Diagnostic Test: Blood-specific miRNA levels

Gentamicin

Critically ill patients who suffered from sepsis, treated with gentamicin.

Diagnostic Test: Blood-specific miRNA levels

Other antibiotic groups

Critically ill patients who suffered from sepsis, treated by other antibiotic groups except for vancomycin or aminoglycoside (gentamicin).

Diagnostic Test: Blood-specific miRNA levels

Interventions

Blood-specific miRNA levels DIAGNOSTIC_TEST

Blood-specific miRNA levels associated with renal tubular damage change in patients treated with vancomycin or gentamicin compared to septic patients treated with other antimicrobials.

Gentamicin; Other antibiotic groups; Vancomycin

Eligibility Criteria

• Age: 18 Years - 95 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Critically ill patients suffering from sepsis and treated with vancomycin, gentamicin, or other antibiotic groups.

You may qualify if:

• \- Critically ill adult septic patients with or without acute kidney injury treated by antimicrobial therapy

You may not qualify if:

• \- Patients in the chronic dialysis program, with stage 4 and 5 chronic kidney disease, or concomitantly treated with another potentially severe nephrotoxic medication (cisplatin, colistin) or combination vancomycin/gentamicin.

Sponsors & Collaborators

• University Hospital Ostrava: lead
• Palacky University: collaborator
• University Hospital Olomouc: collaborator
• University of Ostrava: collaborator
• Technical University of Ostrava: collaborator

Study Sites (1)

University Hospital Ostrava

Ostrava, Moravian-Silesian Region, 70852, Czechia

Location

Related Publications (4)

• Singer M, Deutschman CS, Seymour CW, Shankar-Hari M, Annane D, Bauer M, Bellomo R, Bernard GR, Chiche JD, Coopersmith CM, Hotchkiss RS, Levy MM, Marshall JC, Martin GS, Opal SM, Rubenfeld GD, van der Poll T, Vincent JL, Angus DC. The Third International Consensus Definitions for Sepsis and Septic Shock (Sepsis-3). JAMA. 2016 Feb 23;315(8):801-10. doi: 10.1001/jama.2016.0287.

  PMID: 26903338 BACKGROUND

• Eckardt KU, Kasiske BL. Kidney disease: improving global outcomes. Nat Rev Nephrol. 2009 Nov;5(11):650-7. doi: 10.1038/nrneph.2009.153. Epub 2009 Sep 29.

  PMID: 19786993 BACKGROUND

• Petejova N, Martinek A, Zadrazil J, Kanova M, Klementa V, Sigutova R, Kacirova I, Hrabovsky V, Svagera Z, Stejskal D. Acute Kidney Injury in Septic Patients Treated by Selected Nephrotoxic Antibiotic Agents-Pathophysiology and Biomarkers-A Review. Int J Mol Sci. 2020 Sep 26;21(19):7115. doi: 10.3390/ijms21197115.

  PMID: 32993185 BACKGROUND

• Petejova N, Martinek A, Zadrazil J, Klementa V, Pribylova L, Bris R, Kanova M, Sigutova R, Kacirova I, Svagera Z, Bace E, Stejskal D. Expression and 7-day time course of circulating microRNAs in septic patients treated with nephrotoxic antibiotic agents. BMC Nephrol. 2022 Mar 19;23(1):111. doi: 10.1186/s12882-022-02726-6.

  PMID: 35305556 DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

Whole blood samples

MeSH Terms

Conditions

Sepsis; Shock, Septic; Acute Kidney Injury

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Shock; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• Naděžda Petejová, Assoc.Prof.,MD,PhD,MSc

  University Hospital Ostrava

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 27, 2021
• First Posted: August 5, 2021
• Study Start: May 2, 2019
• Primary Completion: June 30, 2021
• Study Completion: December 1, 2022
• Last Updated: December 6, 2022

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share

Locations

CZ (1)