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

August 1, 2021 updated by: Dániel Ragán, MD, University of Pecs

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
84

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Hungary
    • Baranya
      • Pécs, Baranya, Hungary, 7624
        • Department of Anesthesiology and Intensive Therapy, Medical School, University of Pécs

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 90 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Diagnosed septic or sepsis-related acute kidney injury patients

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Sepsis
Patients receive sepsis therapy.
Other: 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.
Sepsis-related acute kidney injury
Patients receive sepsis and sepsis-related acute kidney injury therapy.
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
3 days
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.
3 days

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
5 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Pecs

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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: Bálint Nagy, MD, PhD, Department of Anesthesiology and Intensive Therapy, Medical School, University of Pécs
  • Study Director: Diána Mühl, MD, PhD, Department of Anesthesiology and Intensive Therapy, Medical School, University of Pécs

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2016

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2019

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 8, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 8, 2021

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 20, 2021

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 9, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 1, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • no. 4327.316-2900/KK15/2011
  • KA-2018-17 (OTHER_GRANT: Medical School, University of Pécs)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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