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

NCT ID: NCT04968262

Last Updated: 2021-08-09

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 84 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2016-01-01
• Study Completion Date: 2019-12-31

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.

Conditions

Sepsis; Acute Kidney Injury Due to Sepsis

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Sepsis

Patients receive sepsis therapy.

Sepsis therapy

Intervention Type: 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

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

Sepsis-related acute kidney injury therapy

Intervention Type: 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.

Interventions

Sepsis therapy

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.

Intervention Type: OTHER

Sepsis-related acute kidney injury therapy

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.

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Pecs

OTHER

Sponsor Role: lead

Responsible Party

Dániel Ragán, MD

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Dániel Ragán, MD

Role: PRINCIPAL_INVESTIGATOR

Department of Laboratory Medicine, Medical School, University of Pécs

Péter Kustán, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Department of Laboratory Medicine, Medical School, University of Pécs

Zoltán Horváth-Szalai, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Department of Laboratory Medicine, Medical School, University of Pécs

Balázs Szirmay, MD

Role: PRINCIPAL_INVESTIGATOR

Department of Laboratory Medicine, Medical School, University of Pécs

Beáta Bugyi, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Department of Biophysics, Medical School, University of Pécs

Andrea Ludány, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Department of Laboratory Medicine, Medical School, University of Pécs

Attila Miseta, MD, DsC

Role: PRINCIPAL_INVESTIGATOR

Department of Laboratory Medicine, Medical School, University of Pécs

Bálint Nagy, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

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

Diána Mühl, MD, PhD

Role: STUDY_DIRECTOR

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

Locations

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

Pécs, Baranya, Hungary

Countries

Hungary

References

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.

Reference Type: RESULT

PMID: 34310652 (View on PubMed)

Other Identifiers

KA-2018-17

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

no. 4327.316-2900/KK15/2011

Identifier Type: -

Identifier Source: org_study_id