Acute Kidney Injury in Severe Trauma
Incidence, Prediction and Time-dependent Role of Risk Factors of Acute Kidney Injury in Severe Trauma: Prospective Observational Cohort Study
1 other identifier
observational
81
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Jun 2013
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
January 31, 2016
CompletedFirst Submitted
Initial submission to the registry
February 7, 2018
CompletedFirst Posted
Study publicly available on registry
February 14, 2018
CompletedFebruary 14, 2018
February 1, 2018
2.6 years
February 7, 2018
February 7, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Acute Kidney Injury biomarker validity
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 Outcomes (1)
Time-dependent role of insults
36 months
Study Arms (1)
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.
Interventions
Blood neutrophil gelatinase-associated lipocalin (NGAL) test was performed in all patients.
Arterial lactate level was assessed in all patients.
The level of interleukin-6 was assessed in all patients.
The level of procalcitonin (PCT) was assessed in all patients.
Eligibility Criteria
Severely injured patients (ISS \> 24) older than 18 years.
You may qualify if:
- \- severe injury (ISS \>24)
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University Hospital Ostrava
Ostrava, Moravian-Silesian Region, 70852, Czechia
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Peter Sklienka, MD
University Hospital Ostrava
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 7, 2018
First Posted
February 14, 2018
Study Start
June 1, 2013
Primary Completion
December 31, 2015
Study Completion
January 31, 2016
Last Updated
February 14, 2018
Record last verified: 2018-02