Acute Kidney Injury in Severe Trauma

February 7, 2018 updated by: University Hospital Ostrava

Incidence, Prediction and Time-dependent Role of Risk Factors of Acute Kidney Injury in Severe Trauma: Prospective Observational Cohort Study

Acute kidney injury (AKI) represents a serious complication following severe injury associated with adverse outcome. Main goals of the presented study were to define the incidence of AKI and to evaluate the validity of AKI biomarker neutrophil gelatinase-associated lipocalin (NGAL) in AKI prediction in severely injured patients. Secondary goals were to determine the time-dependent role of injury-related tissue hypoxia, systemic inflammatory response, and rhabdomyolysis in the pathophysiology of 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.

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

The main goal of the presented study was to define the epidemiology of AKI and to evaluate the validity of AKI biomarker neutrophil gelatinase-associated lipocalin in AKI prediction in severely injured patients with Injury Severity Score (ISS) > 24. Secondary goals were to determine the time-dependent role of insults associated directly with the intensity of injury (tissue hypoxia, systemic inflammatory response and/or infection, rhabdomyolysis) in the pathophysiology of AKI.

The study was performed in a single center at the University Hospital in Ostrava in the Czech Republic. The Ethics Committee of the University Hospital Ostrava approved the study, which conformed to the tenets of the Declaration of Helsinki. Each of the awake and conscious study subjects signed the Informed Consent Form approved by the Ethics Committee of the University Hospital Ostrava. For enrolment of unconscious study subjects who were unable to sign informed consent, approval of two independent (i.e. not involved in the study) physicians was needed.

Patients and methods: All adult severely injured patients defined by Injury Severity Scale (ISS) > 24 admitted to the Department of Anaesthesiology and Intensive Care in University Hospital Ostrava between June 2013 and December 2015 were enrolled into the study. Subjects were screened for AKI presence defined by Kidney Disease: Improving Global Outcomes (KDIGO) criteria daily up to 8 days after injury. Arterial levels of neutrophil gelatinase-associated lipocalin (NGAL), lactate, interleukin-6 (IL-6), procalcitonin (PCT) and myoglobin were investigated at the time points 24 hours (T1), 48 hours (T2) and 96 hours (T3) after injury.

Methods All consecutive severely injured patients (ISS > 24) older than 18 years of age were enrolled in this prospective observational study between June 2013 and December 2015. All participants were admitted to the Level 1 Trauma Centre (Department of Anaesthesiology and Critical Care) at the University Hospital of Ostrava. Exclusion criteria included age < 18 years, history of kidney disease, pregnancy, death within 24 hours after injury, unsurvivable injury with an end of life decision (withhold or withdraw of therapy) pronounced within 24 hours after injury and, finally, clinical signs of brain death within 24 hours after injury.

Basic observed demographic parameters included age, ISS and mechanism of injury. The laboratory parameters included blood NGAL; arterial lactate level, IL-6, PCT and myoglobin at the 24 hours (T1), 48 hours (T2) and 96 hours (T3) after injury. Serum Creatinine level was assessed once daily at 6.00 a.m. and urine output collected hourly from admission (D0) to Day 8 were the basis for evaluation of AKI presence. Because of the recent pre-injury values of Creatinine were unknown almost in all of the subjects, first serum Creatinine level (sCr) taken on admission to the emergency room was used as a baseline reference value.

All diagnostic and therapeutic interventions were performed in accordance with guidelines and standards for the treatment of the critically injured patients. The study protocol does not contain any additional diagnostic or therapeutic intervention except the laboratory investigations mentioned above.

Early AKI defined according to KDIGO criteria occurs in one-third of victims of severe injury. Blood NGAL levels during the first 96 hours after injury are significantly higher in patients who subsequently develop AKI. Prolonged tissue hypoxia, excessive and prolonged activation of inflammatory response and rhabdomyolysis are factors contributing the development of AKI.

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.
81

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

  • Czechia
    • Moravian-Silesian Region
      • Ostrava, Moravian-Silesian Region, Czechia, 70852
        • University Hospital Ostrava

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 99 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Severely injured patients (ISS > 24) older than 18 years.

Description

Inclusion Criteria:

- severe injury (ISS >24)

Exclusion Criteria:

  • age < 18 years
  • history of kidney disease
  • pregnancy
  • death within 24 hours after injury
  • unsurvivable injury (withheld or withdrawn therapy) within 24 hours after injury
  • clinical signs of brain death within 24 hours after injury

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: Case-Only
  • 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.
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.
Acute Kidney Injury
Patients > 18 years of age with acute kidney injury were enroled into the study. Arterial levels of neutrophil gelatinase-associated lipocalin (NGAL), arterial lactate, interleukin-6 (IL-6), procalcitonin (PCT) and myoglobin were investigated in all patients.
Diagnostic test: Neutrophil gelatinase-associated lipocalin (NGAL)
Blood neutrophil gelatinase-associated lipocalin (NGAL) test was performed in all patients.
Diagnostic test: Arterial lactate
Arterial lactate level was assessed in all patients.
Diagnostic test: Interleukin-6 (IL-6)
The level of interleukin-6 was assessed in all patients.
Diagnostic test: Procalcitonin (PCT)
The level of procalcitonin (PCT) was assessed in all patients.
Diagnostic test: Myoglobin
The level of myoglobin was assessed in all patients.

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 biomarker validity
Time Frame: 36 months
The main goal of the study was to evaluate the validity of AKI biomarker neutrophil gelatinase-associated lipocalin in AKI prediction in severely injured patients with Injury Severity Score (ISS) > 24.
36 months

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
Time-dependent role of insults
Time Frame: 36 months
Secondary outcome measure was to determine the time-dependend role of insults associated directly with intensity of injury (tissue hypoxia, systemic inflammatory response and/or infection, rhabdomyolysis) in the pathopfysiology of AKI.
36 months

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 Hospital Ostrava

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: Peter Sklienka, MD, University Hospital Ostrava

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.
June 1, 2013

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, 2015

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.
January 31, 2016

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).
February 7, 2018

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.
February 7, 2018

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.
February 14, 2018

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.
February 14, 2018

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.
February 7, 2018

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.
February 1, 2018

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.
  • FNO-KARIM-6

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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