Urinary Actin, as a Potential Marker of Sepsis-related Acute Kidney Injury

NCT04968262 | Completed

• 2 other identifiers: no. 4327.316-2900/KK15/2011KA-2018-17
• Study Type: observational
• Target: 84
• Locations: 1 country
• Sites: 1

Brief Summary

In our study, 17 septic, 43 sepsis-related acute kidney injury and 24 control patients were enrolled. Blood and urine samples were collected at the intensive care unit from acutely diagnosed septic and sepsis-related acute kidney injury patients at three time points (T1-3): T1: within 24 hours after admission; T2: second day morning; T3: third day morning of follow-up. Patients with malignancies needing palliative care, end-stage renal disease or kidney transplantation were excluded. Not more than one sample (venous blood, midstream spot urine) was collected from control patients. Serum and urinary actin levels were determined by quantitative Western blot. Urinary actin concentrations were expressed as µg/L, while serum actin levels were expressed as mg/L. Data were compared with laboratory and clinical parameters. Patients were categorized by the Sepsis-3 definitions and 30-day mortality data were investigated.

Conditions

Sepsis; Acute Kidney Injury Due to Sepsis

Keywords

Sepsis-3; Acute Kidney Injury; Urinary actin; Western blot

Outcome Measures

Primary Outcomes (2)

• Urinary actin concentrations

  Urine samples were centrifuged (10 min, 1500 g) and supernatants were treated with electrophoresis sample buffer then heated at 100 °C for 5 minutes. Urinary actin was determined by quantitative Western blot. Native and denatured sample aliquots were stored at -70 °C until analysis.

  3 days

• Serum actin concentrations

  Clotted blood samples were centrifuged (10 min, 1500 g) and supernatants were treated with electrophoresis sample buffer then heated at 100 °C for 5 minutes. Serum actin was determined by quantitative Western blot. Native and denatured sample aliquots were stored at -70 °C until analysis.

  3 days

Secondary Outcomes (1)

• U-actin/u-creatinine concentrations

  5 days

Study Arms (2)

Sepsis

Patients receive sepsis therapy.

Other: Sepsis therapy

Sepsis-related acute kidney injury

Patients receive sepsis and sepsis-related acute kidney injury therapy.

Other: Sepsis-related acute kidney injury therapy

Interventions

Sepsis therapy OTHER

Patients receiving sepsis therapy followed the international guidelines of the 2016 Surviving Sepsis Campaign regarding fluid resuscitation, feeding, vasopressor, respiratory, anticoagulation and hydrocortisone therapy, along with ulcer prophylaxis and sedation. Blood and urine samples were collected at the intensive care unit from this patient group at three time points (T1-3): T1: within 24 hours after admission; T2: second day morning; T3: third day morning of follow-up. 24 patients were documented without sepsis and acute kidney injury as a control group.

Sepsis

Sepsis-related acute kidney injury therapy OTHER

Patient management of sepsis and sepsis-related acute kidney injury followed the international guidelines of the 2016 Surviving Sepsis Campaign regarding fluid resuscitation, feeding, vasopressor, respiratory, anticoagulation and hydrocortisone therapy, along with ulcer prophylaxis, sedation and renal replacement therapy (if needed). In this patient group, blood and urine sampling was performed at three time points (T1-3): T1: within 24 hours after admission; T2: second day morning; T3: third day morning of follow-up.

Sepsis-related acute kidney injury

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Diagnosed septic or sepsis-related acute kidney injury patients

You may qualify if:

• Sepsis
• Sepsis-related acute kidney injury

You may not qualify if:

• malignancies needing palliative care
• end-stage renal disease
• kidney transplantation
• under 18 years of age
• unobtainable consent

Sponsors & Collaborators

• University of Pecs: lead

Study Sites (1)

Department of Anesthesiology and Intensive Therapy, Medical School, University of Pécs

Pécs, Baranya, 7624, Hungary

Location

Related Publications (1)

• Ragan D, Kustan P, Horvath-Szalai Z, Szirmay B, Bugyi B, Ludany A, Miseta A, Nagy B, Muhl D. Urinary actin, as a potential marker of sepsis-related acute kidney injury: A pilot study. PLoS One. 2021 Jul 26;16(7):e0255266. doi: 10.1371/journal.pone.0255266. eCollection 2021.

  PMID: 34310652 RESULT

Biospecimen

Retention: SAMPLES WITH DNA

Blood; Urine

MeSH Terms

Conditions

Sepsis; Acute Kidney Injury

Condition Hierarchy (Ancestors)

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

Study Officials

• Dániel Ragán, MD

  Department of Laboratory Medicine, Medical School, University of Pécs

  PRINCIPAL INVESTIGATOR

• Péter Kustán, MD, PhD

  Department of Laboratory Medicine, Medical School, University of Pécs

  PRINCIPAL INVESTIGATOR

• Zoltán Horváth-Szalai, MD, PhD

  Department of Laboratory Medicine, Medical School, University of Pécs

  PRINCIPAL INVESTIGATOR

• Balázs Szirmay, MD

  Department of Laboratory Medicine, Medical School, University of Pécs

  PRINCIPAL INVESTIGATOR

• Beáta Bugyi, MD, PhD

  Department of Biophysics, Medical School, University of Pécs

  PRINCIPAL INVESTIGATOR

• Andrea Ludány, MD, PhD

  Department of Laboratory Medicine, Medical School, University of Pécs

  PRINCIPAL INVESTIGATOR

• Attila Miseta, MD, DsC

  Department of Laboratory Medicine, Medical School, University of Pécs

  PRINCIPAL INVESTIGATOR

• Bálint Nagy, MD, PhD

  Department of Anesthesiology and Intensive Therapy, Medical School, University of Pécs

  PRINCIPAL INVESTIGATOR

• Diána Mühl, MD, PhD

  Department of Anesthesiology and Intensive Therapy, Medical School, University of Pécs

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 8, 2021
• First Posted: July 20, 2021
• Study Start: January 1, 2016
• Primary Completion: December 31, 2019
• Study Completion: December 31, 2019
• Last Updated: August 9, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

HU (1)