Blood Glucose, HighNCT04100369
Admission Blood Glucose as a Predictor of Morbidity and Mortality in Polytraumatized Patients
An observational study of Blood Glucose, High, run by Assiut University.
Trial summary
In polytrraumatized patients, Does hyperglycaemia on admission increase the risk of morbidity and mortality compared to polytraumatised patients with normal blood glucose level ? Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Blood Glucose, High
- What is being tested?
- laboratory
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2020to 31 Dec 2020
- How long will I take part?
- 3 Weeks
- 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
- Adult, Older adult
Study population: using blood glucose as an easy and a rapid predictor of morbidity and mortality in poly traumatized patients
Who may be able to join
- • Age >= 18 years
- Polytrauma ISS >= 18
- Recent polytrauma patients who are directly transferred by the ambulance from the scene of accident to assiut university hospital and did not receive resuscitative measurements in another hospital
Who cannot join
- known co-morbidities affecting blood glucose level like :
- Pregnant women
- Diabetic patients
Trial locations and contacts
No sites are listed yet.
About this study
In polytrraumatized patients, Does hyperglycaemia on admission increase the risk of morbidity and mortality compared to polytraumatised patients with normal blood glucose level ?
Read the detailed description
Trauma is still the leading cause of death in young adults and a major cause of morbidity and mortality at all ages.(1,2). Polytrauma is defined as injury to several physical regions or organ systems, where at least one injury or the combination of several injuries are life threatening with the severity of injury being equal or >16 on the scale of the Injury Severity Score (ISS). Prediction of mortality in trauma patients is an important part of trauma care (3). The trauma and injury severity score (TRISS) and Acute Physiology and Chronic Health Evaluation IV (APACHE IV) are used commonly to predict injury severity and risk of mortality. Although it is regarded as the international standard in trauma scoring, it has complex calculating and incorporates the Glasgow Coma Scale (GCS) for neurological evaluation (4). Regardless of the accuracy of trauma scores, is based on an anatomical description of every injury and cannot be assigned to the patients until a full diagnostic procedure has been performed(5) . Many studies have revealed alteration in glucose metabolism in trauma and proportional relation of its high level to the degree of injury (6). hyperglycaemia is associated with similar complications as uncontrolled diabetes, including an increased mortality, an increased number of infectious complications, and poor wound healing. The presence of elevated blood glucose also impedes normal host defences against infection and impairs the normal inflammatory response (7.8).
- Therefore, this study will be conducted to compare between alterations in easy and rapid predictors as glucose level, base deficit and lactate and difficult and slow predictors as TRISS and APACHE IV. So, it could be considered an early and easy rapid predictor of outcome .
- Conditions
- Blood Glucose, High
- Being tested
- laboratory
- Keywords
- shock , poly trauma , serum lactate
- Medical subject headings
- Shock
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
laboratoryDiagnostic test
Arm
What is being measured
The primary outcome is the main question the study is designed to answer.
Admission blood glucose as a predictor of morbidity and mortality in polytraumatized patients
to investigate the admission blood glucose level as a predictor of morbidity and mortality in poly traumatized patients
Measured: baseline
Secondary outcomes (1)
Admission blood glucose as a predictor of morbidity and mortality in polytraumatized patients
correlation of blood glucose level to serum lactate , interlukin6 , C reactive protein , coagulation profile and their use as biomarkers in polytraumatized patients
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2019
- Study start1 Jan 2020 (estimated)
- Primary completion1 Sep 2020 (estimated)
- Study completion31 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Blood Glucose, HighStudies 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
- Prospective
- Enrolment
- 100 participants (estimated)
- Target duration
- 3 Weeks
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, tamer refaat hanna armanious, Assiut University
- Investigators
- Hossam Abubeih, ass.prof, Study director, Assiut Universityfasil adam, prof, Study director, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04100369
- Sponsor's protocol ID
- blood glucose
- Status last verified
- Sep 2019
- First submitted
- 20 Sep 2019
- Last updated
- 24 Sep 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Laird AM, Miller PR, Kilgo PD, Meredith JW, Chang MC. Relationship of early hyperglycemia to mortality in trauma patients. J Trauma. 2004 May;56(5):1058-62. doi: 10.1097/01.ta.0000123267.39011.9f.
PubMed 15179246Lichtveld RA, Panhuizen IF, Smit RB, Holtslag HR, van der Werken C. Predictors of Death in Trauma Patients who are Alive on Arrival at Hospital. Eur J Trauma Emerg Surg. 2007 Feb;33(1):46-51. doi: 10.1007/s00068-007-6097-6. Epub 2007 Feb 27.
PubMed 26815974
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Admission Blood Glucose as a Predictor of Morbidity and Mortality in Polytraumatized Patients
- ClinicalTrials.gov ID
- NCT04100369
- Acronym / sponsor ID
- blood glucose
- Conditions
- Blood Glucose, High
- Keywords
- shock , poly trauma , serum lactate
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Jan 2020 (estimated)
- Primary completion
- 1 Sep 2020 (estimated)
- Study completion
- 31 Dec 2020 (estimated)
- First posted
- 24 Sep 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 polytrraumatized patients, Does hyperglycaemia on admission increase the risk of morbidity and mortality compared to polytraumatised patients with normal blood glucose level ?
Detailed description
Trauma is still the leading cause of death in young adults and a major cause of morbidity and mortality at all ages.(1,2). Polytrauma is defined as injury to several physical regions or organ systems, where at least one injury or the combination of several injuries are life threatening with the severity of injury being equal or >16 on the scale of the Injury Severity Score (ISS). Prediction of mortality in trauma patients is an important part of trauma care (3). The trauma and injury severity score (TRISS) and Acute Physiology and Chronic Health Evaluation IV (APACHE IV) are used commonly to predict injury severity and risk of mortality. Although it is regarded as the international standard in trauma scoring, it has complex calculating and incorporates the Glasgow Coma Scale (GCS) for neurological evaluation (4). Regardless of the accuracy of trauma scores, is based on an anatomical description of every injury and cannot be assigned to the patients until a full diagnostic procedure has been performed(5) . Many studies have revealed alteration in glucose metabolism in trauma and proportional relation of its high level to the degree of injury (6). hyperglycaemia is associated with similar complications as uncontrolled diabetes, including an increased mortality, an increased number of infectious complications, and poor wound healing. The presence of elevated blood glucose also impedes normal host defences against infection and impairs the normal inflammatory response (7.8).
- Therefore, this study will be conducted to compare between alterations in easy and rapid predictors as glucose level, base deficit and lactate and difficult and slow predictors as TRISS and APACHE IV. So, it could be considered an early and easy rapid predictor of outcome .
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Weeks
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- using blood glucose as an easy and a rapid predictor of morbidity and mortality in poly traumatized patients
Key inclusion criteria (3 listed)
- • Age >= 18 years
Key exclusion criteria (3 listed)
- known co-morbidities affecting blood glucose level like :
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 |
|---|---|---|
| laboratoryArm | Diagnostic test | – |
Primary outcome
Admission blood glucose as a predictor of morbidity and mortality in polytraumatized patients
Time frame: baseline
to investigate the admission blood glucose level as a predictor of morbidity and mortality in poly traumatized patients
1 secondary outcome
Admission blood glucose as a predictor of morbidity and mortality in polytraumatized patients
Time frame: baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2019.
- Background: PubMed 15179246Laird AM, Miller PR, Kilgo PD, Meredith JW, Chang MC. Relationship of early hyperglycemia to mortality in trauma patients. J Trauma. 2004 May;56(5):1058-62. doi: 10.1097/01.ta.0000123267.39011.9f.
- Background: PubMed 26815974Lichtveld RA, Panhuizen IF, Smit RB, Holtslag HR, van der Werken C. Predictors of Death in Trauma Patients who are Alive on Arrival at Hospital. Eur J Trauma Emerg Surg. 2007 Feb;33(1):46-51. doi: 10.1007/s00068-007-6097-6. Epub 2007 Feb 27.
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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.
Hossam Abubeih, ass.prof study director
Assiut University
fasil adam, prof study director
Assiut University
Questions about this trial
What is this clinical trial studying?
An observational study of Blood Glucose, High, run by Assiut University.
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 3 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 24 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact tamer armanious, MD (+201203523938, tamerrefaat2244@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Admission blood glucose as a predictor of morbidity and mortality in polytraumatized patients (time frame: baseline). 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 NCT04100369, which also lists 2 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 24 Sep 2019.