Clinical trial NCT04968262: Urinary Actin, as a Potential Marker of Sepsis-related Acute Kidney Injury
Official title: Urinary Actin, as a Potential Marker of Sepsis-related Acute Kidney Injury: a Pilot Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Sepsis
Acute Kidney Injury Due to Sepsis
Keywords: Sepsis-3
Acute Kidney Injury
Urinary actin
Western blot
Lead sponsor: University of Pecs
Sponsor class: OTHER
First posted: 2021-07-20
Enrollment: 84
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Diagnosed septic or sepsis-related acute kidney injury patients

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.

Detailed description: Actin is a globular protein present in every cell with a 42 kilodalton molecular mass. It plays an important role in muscle contraction while being an essential component of the cytoskeleton as well. Several proteins (e.g. gelsolin, Gc-globulin) bind actin in the circulation during the physiological cell turnover, thus making its urinary appearance unlikely. However, recent studies indicate that actin could be detected in the urine of kidney-transplant patients with acute kidney injury. Therefore, the main focus of our research was the detection and measurement of actin in the blood and urine in patients with sepsis or sepsis-related acute kidney injury, as the early recognition of kidney injury - especially in sepsis - is essential in the aspect of therapy and survival.

Eligibility criteria: Inclusion Criteria:

* Sepsis
* Sepsis-related acute kidney injury

Exclusion Criteria:

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

Primary outcomes:
measure: Urinary actin concentrations
timeFrame: 3 days
measure: Serum actin concentrations
timeFrame: 3 days
Secondary outcomes:
measure: U-actin/u-creatinine concentrations
timeFrame: 5 days
Other outcomes:
Locations:
city: Pécs
country: Hungary
facility: Department of Anesthesiology and Intensive Therapy, Medical School, University of Pécs
state: Baranya
Study officials:
affiliation: Department of Laboratory Medicine, Medical School, University of Pécs
name: Dániel Ragán, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Laboratory Medicine, Medical School, University of Pécs
name: Péter Kustán, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Laboratory Medicine, Medical School, University of Pécs
name: Zoltán Horváth-Szalai, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Laboratory Medicine, Medical School, University of Pécs
name: Balázs Szirmay, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Biophysics, Medical School, University of Pécs
name: Beáta Bugyi, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Laboratory Medicine, Medical School, University of Pécs
name: Andrea Ludány, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Laboratory Medicine, Medical School, University of Pécs
name: Attila Miseta, MD, DsC
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Anesthesiology and Intensive Therapy, Medical School, University of Pécs
name: Bálint Nagy, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Anesthesiology and Intensive Therapy, Medical School, University of Pécs
name: Diána Mühl, MD, PhD
role: STUDY_DIRECTOR
References:
citation: 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.