İntensive Care UnitNCT03894111
ICU Mortality Predictors of Trauma Patients
An observational study of İntensive Care Unit, run by Balikesir University at 1 site in Turkey (Türkiye).
Trial summary
In this study, the data of the patients who were hospitalized due to trauma in intensive care unit (ICU) were examined in their first development. The mortality rate and the factors affecting mortality in these patients were determined Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- İntensive Care Unit
- What is being tested?
- decesased patients
- How many people
- 107 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2019to 27 Mar 2019
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: all trauvma patients in one year
Who may be able to join
- trauvma patients
Who cannot join
- systemic inflammatory diseases
- cancer
- renal failure
- cardiac failure
- serebro vascular diseases
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prognostic Effect of Neutrophil \ Lymphocyte Ratio, Lactate Level and Apache 2 Score on Mortality in Intensive Care Trauma Patients at First Hospitalizations
In this study, the data of the patients who were hospitalized due to trauma in intensive care unit (ICU) were examined in their first development. The mortality rate and the factors affecting mortality in these patients were determined
Read the detailed description
In this study, 107 trauma patients were examined. Patients were divided into two groups according to ICU results: survivors (Group 1) and deceased patients (Group2). Patients were rated in terms of age, Neutrophil lymphocyte ratio (NLR) , mean platelet volüme (MPV), lactat value, intensive care unit stay, APACHE 2 soring systems. Mortality rate and the factors affecting this rate were examined.
83 of the patients were male (77.58%) and 24 were female (22.42%). The mean age was 46 years. The mean value of lactate level was 3.25. MPV mean value was 10.34. NLR mean value was 8.23 and Apache 2 score mean value was 22.8. The average length of stay in hospital was 11.33 days. When the intergroup mortality was evaluated in terms of the relationship between continuous variables, there was a statistically significant difference in apache 2 score. No statistically significant difference was found between age, lactate, MPV, NRL and length of hospital stay.
NRL, MPV, Lactate levels were not suitable for evaluation of trauma patients as a early prognostic factor in the first day ICU admission. The investigators think that the use of trauma scoring systems such as apache 2 related to mortality during first hospitalization in ICU is more appropriate.
- Conditions
- İntensive Care Unit
- Being tested
- decesased patients
- Keywords
- trauma, mortality
- Medical subject headings
- Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
decesased patientsOther
mortality ratio
| Study group | Role | What they receive |
|---|---|---|
| living patients | living patients in intersivecare unit about 28 days Receives: Other: decesased patients | |
| deceased patients | deceased patients in intersivecare unit about 28 days Receives: Other: decesased patients |
What is being measured
The primary outcome is the main question the study is designed to answer.
mortallty
mortallty ratio
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2019
- Study start1 Jan 2019
- Primary completion27 Mar 2019
- Study completion27 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for İntensive Care UnitStudies of the same condition, open and under way.
- 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
- Other
- Time perspective
- Retrospective
- Enrolment
- 107 participants (actual)
Sponsor and investigators
- Lead sponsor
- Balikesir University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, bülent atik, Balikesir University
- Investigators
- bülent atik, md, Principal investigator, Netherlands: Ministry of Health, Welfare and Sports
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03894111
- Sponsor's protocol ID
- 2019/32
- Status last verified
- Mar 2019
- First submitted
- 26 Mar 2019
- Last updated
- 28 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Zahorec R. Ratio of neutrophil to lymphocyte counts--rapid and simple parameter of systemic inflammation and stress in critically ill. Bratisl Lek Listy. 2001;102(1):5-14. English, Slovak.
PubMed 11723675Chen W, Yang J, Li B, Peng G, Li T, Li L, Wang S. Neutrophil to Lymphocyte Ratio as a Novel Predictor of Outcome in Patients With Severe Traumatic Brain Injury. J Head Trauma Rehabil. 2018 Jan/Feb;33(1):E53-E59. doi: 10.1097/HTR.0000000000000320.
PubMed 28520670Dilektasli E, Inaba K, Haltmeier T, Wong MD, Clark D, Benjamin ER, Lam L, Demetriades D. The prognostic value of neutrophil-to-lymphocyte ratio on mortality in critically ill trauma patients. J Trauma Acute Care Surg. 2016 Nov;81(5):882-888. doi: 10.1097/TA.0000000000000980.
PubMed 26825931
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prognostic Effect of Neutrophil \ Lymphocyte Ratio, Lactate Level and Apache 2 Score on Mortality in Intensive Care Trauma Patients at First Hospitalizations
- ClinicalTrials.gov ID
- NCT03894111
- Acronym / sponsor ID
- 2019/32
- Conditions
- İntensive Care Unit
- Keywords
- trauma, mortality
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 107 participants (actual)
- Lead sponsor
- Balikesir UniversityUniversity, hospital or other
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 27 Mar 2019 (actual)
- Study completion
- 27 Mar 2019 (actual)
- First posted
- 28 Mar 2019 (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.
In this study, the data of the patients who were hospitalized due to trauma in intensive care unit (ICU) were examined in their first development. The mortality rate and the factors affecting mortality in these patients were determined
Detailed description
In this study, 107 trauma patients were examined. Patients were divided into two groups according to ICU results: survivors (Group 1) and deceased patients (Group2). Patients were rated in terms of age, Neutrophil lymphocyte ratio (NLR) , mean platelet volüme (MPV), lactat value, intensive care unit stay, APACHE 2 soring systems. Mortality rate and the factors affecting this rate were examined.
83 of the patients were male (77.58%) and 24 were female (22.42%). The mean age was 46 years. The mean value of lactate level was 3.25. MPV mean value was 10.34. NLR mean value was 8.23 and Apache 2 score mean value was 22.8. The average length of stay in hospital was 11.33 days. When the intergroup mortality was evaluated in terms of the relationship between continuous variables, there was a statistically significant difference in apache 2 score. No statistically significant difference was found between age, lactate, MPV, NRL and length of hospital stay.
NRL, MPV, Lactate levels were not suitable for evaluation of trauma patients as a early prognostic factor in the first day ICU admission. The investigators think that the use of trauma scoring systems such as apache 2 related to mortality during first hospitalization in ICU is more appropriate.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| living patients | – | Other: decesased patientsliving patients in intersivecare unit about 28 days |
| deceased patients | – | Other: decesased patientsdeceased patients in intersivecare unit about 28 days |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- all trauvma patients in one year
Key inclusion criteria (1 listed)
- trauvma patients
Key exclusion criteria (5 listed)
- systemic inflammatory diseases
- cancer
- renal failure
- cardiac failure
- serebro vascular diseases
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| decesased patientsmortality ratio | Other | deceased patients, living patients |
Primary outcome
mortallty
Time frame: 28 days
mortallty ratio
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 28 Mar 2019.
- Background: PubMed 11723675Zahorec R. Ratio of neutrophil to lymphocyte counts--rapid and simple parameter of systemic inflammation and stress in critically ill. Bratisl Lek Listy. 2001;102(1):5-14. English, Slovak.
- Background: PubMed 28520670Chen W, Yang J, Li B, Peng G, Li T, Li L, Wang S. Neutrophil to Lymphocyte Ratio as a Novel Predictor of Outcome in Patients With Severe Traumatic Brain Injury. J Head Trauma Rehabil. 2018 Jan/Feb;33(1):E53-E59. doi: 10.1097/HTR.0000000000000320.
- Results publication: PubMed 26825931Dilektasli E, Inaba K, Haltmeier T, Wong MD, Clark D, Benjamin ER, Lam L, Demetriades D. The prognostic value of neutrophil-to-lymphocyte ratio on mortality in critically ill trauma patients. J Trauma Acute Care Surg. 2016 Nov;81(5):882-888. doi: 10.1097/TA.0000000000000980.
- Individual participant dataSharing planned: No
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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.
bülent atik, md principal investigator
Netherlands: Ministry of Health, Welfare and Sports
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 İntensive Care Unit, run by Balikesir 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 5 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 28 Mar 2019. 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?
mortallty (time frame: 28 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03894111, which also lists 3 linked publications.
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 28 Mar 2019; AzTrials last refreshed its copy on 6 Nov 2026.