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NCT Number: NCT04968262

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

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.

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Key information

Conditions

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

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

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

Pécs, Baranya, 7624, Hungary

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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-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.

Primary outcomes

  1. Urinary actin concentrations

    Time frame: 3 days

    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.

  2. Serum actin concentrations

    Time frame: 3 days

    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.

Secondary outcomes

  1. U-actin/u-creatinine concentrations

    Time frame: 5 days

    U-actin values were determined by quantitative Western blot, while U-creatinine concentrations were measured using automated routine laboratory procedures, therefore U-actin/u-creatinine ratios could be calculated.

Sponsors and collaborators

Lead sponsor

University of Pecs

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2019
Study completion
2019
First posted
Jul 20, 2021
Registry last updated
Aug 9, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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