Acute Kidney InjuryNCT05381493
Incidence and Outcomes of Acute Kidney Injury in Trauma Patients Admitted to Critical Care
An observational study of Acute Kidney Injury and Trauma; Complications, run by Ankara University at 1 site in Turkey (Türkiye).
Trial summary
Acute kidney injury (AKI) is a common complication that increases lenght of stay and mortality in trauma patients admitted to the intensive care unit (ICU). The aim of this study is to identify the incidence and outcomes of trauma patients, defined by Kidney Disease Improving Global Outcomes (KDIGO) criteria, at… Read more about this study
- Who is it for?
- Ages 18 to 97 years
- Conditions the study is for
- Acute Kidney Injury, Trauma; Complications
- How many people
- 171 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2021to 10 May 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 97 years
- All sexes
- Adult, Older adult
Study population: all type of trauma patients admitted to level 3 ICU
Who may be able to join
- all type of trauma patients admitted to level 3 ICU, from January 2014 to December 2018
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
About this study
Acute kidney injury (AKI) is a common complication that increases lenght of stay and mortality in trauma patients admitted to the intensive care unit (ICU). The aim of this study is to identify the incidence and outcomes of trauma patients, defined by Kidney Disease Improving Global Outcomes (KDIGO) criteria, at single center level 3 ICU.
Read the detailed description
Trauma can cause high mortality and morbidity by affecting different organ systems. Acute kidney injury (AKI) is a common complication in trauma patients admitted to the intensive care unit (ICU). Direct kidney injury, hypotension, hypoperfusion, rhabdomyolysis, abdominal compartment syndrome, sepsis and critical care medications are possible causes of AKI in trauma patients. The incidence of AKI can be up to 10%, and mortality rate up to 60-80% in trauma patients. Since AKI is not only a rare complication but also a risk factor for mortality in critically ill trauma patients, it is essential to establish a strategy to prevent AKI and related complications, to determine the incidence and risk factors of AKI, and to improve patients outcomes. Survivors of AKI may have variable recovery of kidney function and might prone to late morbidity and mortality. In this study incidence of AKI was defined using the KDIGO criteria according to the change of serum creatine levels.
171 all type of trauma patients admitted to level 3 ICU, from January 2014 to December 2018 included the retrospectve observational study. Demographic data, type of injury, rates of complications, risk factors for AKI, mortality, lenght of stay (LOS) in ICU were evaluated. Acute Physiology and Chronic Health Evaluation (APACHE II and IV) score, Simplified Acute Physiology Score (SAPS II and III), Glasgow Coma Scale (GCS), Injury Severity Score (ISS) and, Trauma Injury Severity Score (TRISS) were calculated on the day of admission. AKI was defined using the KDIGO criteria according to the serum creatinine. The SPSS 11.5 program was used for statistical analysis.
- Conditions
- Acute Kidney Injury, Trauma; Complications
- Keywords
- Trauma, Acute Kidney Injury, Intensive Care Unit
- Medical subject headings
- Acute Kidney Injury, Wounds and Injuries
What is being measured
The primary outcome is the main question the study is designed to answer.
Acute kidney injury in trauma patients
Kidney Disease Improving Global Outcomes (KDIGO) criteria
Measured: one week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2022
- Study start1 Jan 2021
- Primary completion28 Feb 2022
- Study completion10 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Kidney InjuryStudies of the same condition, open and under way.
- More trials run by Ankara UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 171 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ankara University
- Sponsor type
- University, hospital or other
- Collaborators
- Bengi Şafak, Keziban Sanem Çakar Turhan, Mustafa Onur Karaca, Uğur Aydoğan, Ali Abbas Yılmaz, Mustafa Kemal Bayar
- Responsible party
- Principal investigator, Süheyla Karadağ Erkoç, Ankara University
- Investigators
- Süheyla Karadağ Erkoç, Principal investigator, Ankara University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05381493
- Sponsor's protocol ID
- AnkaraUTraumaAKI
- Status last verified
- May 2022
- First submitted
- 15 May 2022
- Last updated
- 19 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Incidence and Outcomes of Acute Kidney Injury in Trauma Patients Admitted to Critical Care
- ClinicalTrials.gov ID
- NCT05381493
- Acronym / sponsor ID
- AnkaraUTraumaAKI
- Conditions
- Acute Kidney Injury, Trauma; Complications
- Keywords
- Trauma, Acute Kidney Injury, Intensive Care Unit
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 171 participants (actual)
- Lead sponsor
- Ankara UniversityUniversity, hospital or other
- Collaborators
- Bengi Şafak, Keziban Sanem Çakar Turhan, Mustafa Onur Karaca, Uğur Aydoğan, Ali Abbas Yılmaz, Mustafa Kemal Bayar
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 28 Feb 2022 (actual)
- Study completion
- 10 May 2022 (actual)
- First posted
- 19 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Acute kidney injury (AKI) is a common complication that increases lenght of stay and mortality in trauma patients admitted to the intensive care unit (ICU). The aim of this study is to identify the incidence and outcomes of trauma patients, defined by Kidney Disease Improving Global Outcomes (KDIGO) criteria, at single center level 3 ICU.
Detailed description
Trauma can cause high mortality and morbidity by affecting different organ systems. Acute kidney injury (AKI) is a common complication in trauma patients admitted to the intensive care unit (ICU). Direct kidney injury, hypotension, hypoperfusion, rhabdomyolysis, abdominal compartment syndrome, sepsis and critical care medications are possible causes of AKI in trauma patients. The incidence of AKI can be up to 10%, and mortality rate up to 60-80% in trauma patients. Since AKI is not only a rare complication but also a risk factor for mortality in critically ill trauma patients, it is essential to establish a strategy to prevent AKI and related complications, to determine the incidence and risk factors of AKI, and to improve patients outcomes. Survivors of AKI may have variable recovery of kidney function and might prone to late morbidity and mortality. In this study incidence of AKI was defined using the KDIGO criteria according to the change of serum creatine levels.
171 all type of trauma patients admitted to level 3 ICU, from January 2014 to December 2018 included the retrospectve observational study. Demographic data, type of injury, rates of complications, risk factors for AKI, mortality, lenght of stay (LOS) in ICU were evaluated. Acute Physiology and Chronic Health Evaluation (APACHE II and IV) score, Simplified Acute Physiology Score (SAPS II and III), Glasgow Coma Scale (GCS), Injury Severity Score (ISS) and, Trauma Injury Severity Score (TRISS) were calculated on the day of admission. AKI was defined using the KDIGO criteria according to the serum creatinine. The SPSS 11.5 program was used for statistical analysis.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 97 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- all type of trauma patients admitted to level 3 ICU
Key inclusion criteria (1 listed)
- all type of trauma patients admitted to level 3 ICU, from January 2014 to December 2018
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Acute kidney injury in trauma patients
Time frame: one week
Kidney Disease Improving Global Outcomes (KDIGO) criteria
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Süheyla Karadağ Erkoç principal investigator
Ankara University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Kidney Injury and Trauma; Complications, run by Ankara University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acute kidney injury in trauma patients (time frame: one week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 May 2022.