Critical CareNCT02749487
Neutrophil Lymphocyte Ratio as a Predictor of Outcome in Critically Traumatic Patients
An observational study of Critical Care, run by Assiut University at 1 site in Egypt.
Trial summary
Neutrophil lymphocyte ratio NLR is an important index that evaluate the inflammatory status . It is a cost effective and readily available , and simply calculated , so that why investigators try to use it as a predictor of short term survival in the critically ill patients Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Critical Care
- What is being tested?
- Neutrophil Lymphocyte Ratio
- How many people
- 80 participants
- Where
- 1 siteEgypt
- Study dates
- Jun 2015to Sep 2016
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 80 adult patients who are admitted to critical care unit in Assiut university Hospital
Who may be able to join
- Critically ill trauma patients
Who cannot join
- auto immune disease endocrine disease renal dysfunction hepatic dysfunction malignancy smoking
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Neutrophil Lymphocyte and Platelet Lymphocyte Ratios as Predictors of Outcome in Traumatic Critically Ill Patients
Neutrophil lymphocyte ratio NLR is an important index that evaluate the inflammatory status . It is a cost effective and readily available , and simply calculated , so that why investigators try to use it as a predictor of short term survival in the critically ill patients
Read the detailed description
NLR will be used as predictor for short term survival and patients stay in ICU in 2 groups of patients . Investigators will use it in a group of Medical Critically ill patients as respiratory failure , neuromuscular disorders , renal impairment . the other group is the critically ill surgical patients , as patients with multiple trauma , post major surgery
- Conditions
- Critical Care
- Being tested
- Neutrophil Lymphocyte Ratio
- Keywords
- Critical Care, Neutrophils, Lymphocytes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neutrophil Lymphocyte RatioOther
Neutrophil:lymphocyte ratio (NLR) is an emerging biomarker that is used to predict mortality and morbidity. The association of this biomarker with systemic illness and its usefulness in risk assessment of critically ill patients has not been fully elucidated.
| Study group | Role | What they receive |
|---|---|---|
| cured (c) | Neutrophil Lymphocyte and platelet lymphocyte ratios as Predictors of Outcome in Traumatic Critically ill Patients Receives: Other: Neutrophil Lymphocyte Ratio | |
| Died ( M) | Neutrophil Lymphocyte and platelet lymphocyte ratios as Predictors of Outcome in Traumatic Critically ill Patients Receives: Other: Neutrophil Lymphocyte Ratio |
What is being measured
The primary outcome is the main question the study is designed to answer.
short term survival
Measured: one month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2016 (estimated)
- Study startJun 2015
- Primary completionMay 2016
- Study completionSep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Critical CareStudies of the same condition, open and under way.
- More trials run by Assiut 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
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Emad Zarief , MD, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02749487
- Sponsor's protocol ID
- IRB00009905
- Status last verified
- Dec 2016
- First submitted
- 21 Apr 2016
- Last updated
- 16 Dec 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neutrophil Lymphocyte and Platelet Lymphocyte Ratios as Predictors of Outcome in Traumatic Critically Ill Patients
- ClinicalTrials.gov ID
- NCT02749487
- Acronym / sponsor ID
- IRB00009905
- Conditions
- Critical Care
- Keywords
- Critical Care, Neutrophils, Lymphocytes
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Jun 2015
- Primary completion
- May 2016 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 25 Apr 2016 (estimated)
- 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.
Neutrophil lymphocyte ratio NLR is an important index that evaluate the inflammatory status . It is a cost effective and readily available , and simply calculated , so that why investigators try to use it as a predictor of short term survival in the critically ill patients
Detailed description
NLR will be used as predictor for short term survival and patients stay in ICU in 2 groups of patients . Investigators will use it in a group of Medical Critically ill patients as respiratory failure , neuromuscular disorders , renal impairment . the other group is the critically ill surgical patients , as patients with multiple trauma , post major surgery
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| cured (c) | – | Other: Neutrophil Lymphocyte RatioNeutrophil Lymphocyte and platelet lymphocyte ratios as Predictors of Outcome in Traumatic Critically ill Patients |
| Died ( M) | – | Other: Neutrophil Lymphocyte RatioNeutrophil Lymphocyte and platelet lymphocyte ratios as Predictors of Outcome in Traumatic Critically ill Patients |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 80 adult patients who are admitted to critical care unit in Assiut university Hospital
Key inclusion criteria (1 listed)
- Critically ill trauma patients
Key exclusion criteria (1 listed)
- auto immune disease endocrine disease renal dysfunction hepatic dysfunction malignancy smoking
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 |
|---|---|---|
| Neutrophil Lymphocyte RatioNeutrophil:lymphocyte ratio (NLR) is an emerging biomarker that is used to predict mortality and morbidity. The association of this biomarker with systemic illness and its usefulness in risk assessment of critically ill patients has not been fully elucidated. | Other | Died ( M), cured (c) |
Primary outcome
short term survival
Time frame: one month
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 16 Dec 2016.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
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 Critical Care, run by Assiut University at 1 site in Egypt.
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 16 Dec 2016. 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 Egypt. 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?
short term survival (time frame: one month). 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 16 Dec 2016.