The Effectiveness of Urine mtDNA and Beta 2-MG to Predict Acute Kidney Injury for Critically Ill Surgical Patients

June 9, 2024 updated by: Kwangmin Kim, Wonju Severance Christian Hospital

The Effectiveness of the Urine Mitochondrial Deoxyribonucleic Acid and, Serum Beta 2 Microglobulin as a Biomarker of Renal Function Impairment in Critically Ill Surgical Patients

1. Research background

  1. Research hypothesis The development of acute kidney injury (AKI) can be predicted using urine mitochondrial deoxyribonucleic acid (UmtDNA), serum and urine beta-2 microglobulin (β2-MG) in critically ill surgical patients

  2. Basis of research hypothesis

    i. Correlation between mitochondria and renal function (Results of previous studies)

    • Mitochondria are involved in development and recovery of diabetic nephropathy.

    • UmtDNA can be used as early marker to detect the development of AKI

      ※ Mitochondria

    • As an organelle located within the cell, it is an organ that produces energy through adenosine triphosphate (ATP) through cellular oxidative phosphorylation.
    • The kidney has the second most mitochondria after the heart.

    II. Correlation between elevation of β2-MG and renal function

    • Circulating β2-MG infiltrates the glomerulus and is reabsorbed and metabolized in the proximal tubule of the kidney. Therefore, it increases in the blood due to a decrease in metabolism when renal function is abnormal.

      ※ Beta 2-microglobulin

    • As the light chain of the class I major histocompatibility antigen, it is a protein distributed in nucleated cells (especially lymphocytes and monocytes) in the body.

    III. Mechanism of acute kidney injury in critically ill surgical patients

    • Blood flow to the kidneys is reduced due to decreased cardiac output, vasoconstriction due to systemic inflammatory response, hemodynamic changes, and decreased body fluid. This leads to renal tubular injury along with ischemic reperfusion injury.
    • Renal tubular injury increases the permeability of the transition pore that connects the outer and inner mitochondrial membranes, resulting in mitochondrial structural damage and oxidative injury. It causes a decrease of ATP in kidney cells and induces apoptosis of kidney cells.
    • Urine mtDNA, a product of this kidney injury, could be used as a biomarker to predict impairment of renal function in critically ill surgical patients.
    • Serum β2-MG maybe increase due to a decrease of metabolism of β2-MG in AKI.

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.

Detailed Description

1. Research objective

  1. Demonstrate of the association between urine mitochondrial deoxyribonucleic acid copy number (UmtDNAcn), beta 2-microglobulin (β2-MG) and acute kidney injury in critically ill surgical patients
  2. Demonstrate of the effectiveness of UmtDNAcn and β2-MG as a biomarker to predict AKI development and recovery

2. Contents of the research project.

  1. Analysis of correlation between UmtDNAcn, β2-MG and development of AKI

    • Verifying the correlation between UmtDNAcn and blood β2-MG measured at the initial presentation and patients diagnosed AKI according to the Acute Kidney Injury Network (AKIN) criteria.

  2. Analysis of correlation between UmtDNAcn, β2-MG and recovery of AKI

    • Verifying the correlation between UmtDNAcn and blood β2-MG measured at the initial presentation and AKI recovery
    • AKI recovery was defined as the case when the AKI stage according to the AKIN criteria on the 7th day of AKI onset was reduced from AKI stage measured at the beginning of the AKI onset.
  3. Comparison with other biomarkers (delta neutrophil index, creatinine, cystatin C) - Comparison of sensitivity and specificity of UmtDNAcn, β2-MG, and other biomarkers previously used such as creatinine, cystatin C, and delta neutrophil index.

3. Strategies and methods for the research project

  1. subject: all surgical patients who planned to admit surgical and trauma intensive care unit in emergency room

  2. Study period and patient recruitment i. 1st and 2nd year

    • 120 patients
  3. Measurement of UmtDNAcn, β2-MG i. urine and blood sampling: at the initial presentation and again on hospital say #1 and #3

  4. Analysis of correlation between UmtDNAcn, β2-MG and AKI development, recovery

    i. Statistical analysis of UmtDNAcn, β2-MG measured at the initial presentation, on hospital day #1, and #3 between patients with no AKI and AKI

    ii. Statistical analysis of UmtDNAcn, β2-MG measured at the initial presentation, on hospital day #1, and #3 between patients with no AKI recovery and AKI recovery

    ※ AKI recovery was defined as the case when the AKI stage according to the AKIN criteria on the 7th day of AKI onset was reduced from AKI stage measured at the beginning of the AKI onset.

    iii. Comparison with other biomarkers (delta neutrophil index, creatinine, cystatin C)

    • Comparison of sensitivity and specificity to predict AKI of UmtDNAcn, β2-MG, and other biomarkers previously used such as creatinine, cystatin C, and delta neutrophil index measure at the initial presentation, on hospital day #1 and #3. .

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.
113

Contacts and Locations

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

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Korea, Republic of
    • Gangwon
      • Wonju, Gangwon, Korea, Republic of, 26426
        • WonJu Severance Christian Hospital

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

19 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

All surgical patients who planned to admit to surgical and trauma intensive care unit in emergency room

Description

Inclusion Criteria:

  • All surgical patients who planned to admit to surgical and trauma intensive care unit in emergency room

Exclusion Criteria:

  • Age ≤18 years
  • Pregnancy in women
  • Chronic kidney disease history
  • Death at initial presentation of the case

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

  • Observational Models: Cohort
  • Time Perspectives: Prospective

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.
Patients admitted in Surgical intensive care unit and trauma intensive care unit
all surgical patients who planned to admit in surgical and trauma intensive care unit in emergency room

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
Acute kidney injury (dichotomous)
Time Frame: Within 30 days after ICU admission
Acute kidney injury according to Acute Kidney Injury Network (AKIN) criteria
Within 30 days after ICU admission
Acute kidney injury recovery (dichotomous)
Time Frame: Within 30 days after ICU admission
the case when the AKI stage according to the AKIN criteria on the 7th day of AKI onset was reduced from AKI stage measured at the beginning of the AKI onset
Within 30 days after ICU admission

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
Mortality (dichotomous)
Time Frame: Within 30 days after ICU admission
The number of deaths
Within 30 days after ICU admission
Hospital length of stay (continuous)
Time Frame: From date of the admission until the date of first discharge from the hospital, assessed up to 60 days
Measured in days from admission to discharge
From date of the admission until the date of first discharge from the hospital, assessed up to 60 days
Intensive care unit (ICU) stay (continuous)
Time Frame: From date of ICU admission (in cases of ICU admission at the initial presentation) until the date of first discharge from ICU, assessed up to 60 days
Measured in days from ICU admission to ICU out
From date of ICU admission (in cases of ICU admission at the initial presentation) until the date of first discharge from ICU, assessed up to 60 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.
Wonju Severance Christian Hospital

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Research Foundation of Korea

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: In Sik Shin, WonJu Severance Christian Hospital

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

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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.
July 25, 2022

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.
June 10, 2024

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.
June 10, 2024

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 11, 2022

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 11, 2022

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 14, 2022

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.
June 11, 2024

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.
June 9, 2024

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.
June 1, 2024

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.
  • BMPAS2022
  • 2022R1I1A1A01069511 (Other Grant/Funding Number: National Research Foundation of Korea)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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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