Trauma InjuryNCT04567901
GNRI and Influence of Nutrition on the Mortality of Trauma Patients
An observational study of Trauma Injury, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
Trial summary
The geriatric nutritional risk index (GNRI) is a simple and efficient tool to assess the nutritional status of patients with malignancies or after surgery. Because trauma patients constitute a specific population that generally acquires accidental and acute injury, this study aimed to identify the association between… Read more about this study
- Who is it for?
- Ages 65 to 100 years
- Conditions the study is for
- Trauma Injury
- What is being tested?
- Death and Survive
- How many people
- 700 participants
- Where
- 1 siteTaiwan
- Study dates
- 7 Sep 2020to 20 Sep 2020
- 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 65 to 100 years
- All sexes
- No healthy volunteers
- Older adult
Study population: The medical records of 39,135 enrolled trauma patients registered between January 1, 2009 and December 31, 2019 were reviewed for this study (Figure 1). The enrolled patients experienced trauma from different injuries and were hospitalized for treatment. Of the 7,136 patients who were admitted to the ICU, 1,926 older trauma patients were aged ≥ 65 years. After excluding patients whose albumin data were not available and those with incomplete data (n = 1,226), 700 older trauma patients were finally included in the study. Detailed information of the study population was extracted from the Trauma Registry System of the hospital.
Who may be able to join
- trauma from different injuries
- hospitalized for treatment
- admitted to the ICU
Who cannot join
- albumin data were not available
- patients with incomplete data
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Using the Geriatric Nutritional Risk Index (GNRI) to Evaluate the Influence of Nutrition on the Mortality of Trauma Patients
The geriatric nutritional risk index (GNRI) is a simple and efficient tool to assess the nutritional status of patients with malignancies or after surgery. Because trauma patients constitute a specific population that generally acquires accidental and acute injury, this study aimed to identify the association between the GNRI at admission and mortality outcomes of older trauma patients in the intensive care unit (ICU).
Read the detailed description
The nutritional risk index (NRI) is a screening method that was primarily developed to identify older patients with malnutrition. It consists of serum albumin levels as well as body weight measurements. However, even under professional care, the usual body weight is often not documented for older patients. To determine the usual body weight of older patients, the geriatric nutritional risk index (GNRI) was introduced in 2005 by Bouillanne et al - the formula included a combination of serum albumin levels and the ratio of body weight to ideal body weight. The GNRI formula replaces the usual body weight in the NRI formula with the ideal body weight, calculated using the Lorentz formula. Although the GNRI was developed using the data of patients who were admitted to a geriatric rehabilitation care unit, it was found to be a strong prognostic factor for certain malignancies and a simple, objective, and quick method to determine the nutritional status of patients and long-term postoperative outcomes and the correlation between these elements. Using this simple calculation, it is possible to evaluate the nutritional status of critically ill patients with acute respiratory distress syndrome in the intensive care unit (ICU). Considering that trauma patients constitute a specific population, as injuries generally occur accidentally and acutely, it is important to determine whether the GNRI can be used to link nutritional status and outcomes in trauma patients. Therefore, this study aimed to identify the association between GNRI at admission and mortality outcomes of older trauma patients in the ICU.
- Conditions
- Trauma Injury
- Being tested
- Death, Survive
- Medical subject headings
- Accidental Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DeathOther
Mortality group
SurviveOther
Survival group
| Study group | Role | What they receive |
|---|---|---|
| Trauma Patients | The enrolled patients experienced trauma from different injuries and were hospitalized for treatment and admitted to the ICU. 700 older trauma patients (age equal to or more than 65 years) were finally included in the study. Receives: Other: Death; Other: Survive |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality outcome
Mortality outcome of older trauma patients in the ICU.
Measured: through study completion, an average of 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2020
- Study start7 Sep 2020
- Primary completion14 Sep 2020
- Study completion20 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Trauma InjuryStudies of the same condition, open and under way.
- More trials run by Chang Gung Memorial HospitalThe 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
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 700 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04567901
- Sponsor's protocol ID
- 202001446B0
- Status last verified
- Sep 2020
- First submitted
- 21 Sep 2020
- Last updated
- 29 Sep 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using the Geriatric Nutritional Risk Index (GNRI) to Evaluate the Influence of Nutrition on the Mortality of Trauma Patients
- ClinicalTrials.gov ID
- NCT04567901
- Acronym / sponsor ID
- 202001446B0
- Conditions
- Trauma Injury
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 700 participants (actual)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Study start
- 7 Sep 2020 (actual)
- Primary completion
- 14 Sep 2020 (actual)
- Study completion
- 20 Sep 2020 (actual)
- First posted
- 29 Sep 2020 (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.
The geriatric nutritional risk index (GNRI) is a simple and efficient tool to assess the nutritional status of patients with malignancies or after surgery. Because trauma patients constitute a specific population that generally acquires accidental and acute injury, this study aimed to identify the association between the GNRI at admission and mortality outcomes of older trauma patients in the intensive care unit (ICU).
Detailed description
The nutritional risk index (NRI) is a screening method that was primarily developed to identify older patients with malnutrition. It consists of serum albumin levels as well as body weight measurements. However, even under professional care, the usual body weight is often not documented for older patients. To determine the usual body weight of older patients, the geriatric nutritional risk index (GNRI) was introduced in 2005 by Bouillanne et al - the formula included a combination of serum albumin levels and the ratio of body weight to ideal body weight. The GNRI formula replaces the usual body weight in the NRI formula with the ideal body weight, calculated using the Lorentz formula. Although the GNRI was developed using the data of patients who were admitted to a geriatric rehabilitation care unit, it was found to be a strong prognostic factor for certain malignancies and a simple, objective, and quick method to determine the nutritional status of patients and long-term postoperative outcomes and the correlation between these elements. Using this simple calculation, it is possible to evaluate the nutritional status of critically ill patients with acute respiratory distress syndrome in the intensive care unit (ICU). Considering that trauma patients constitute a specific population, as injuries generally occur accidentally and acutely, it is important to determine whether the GNRI can be used to link nutritional status and outcomes in trauma patients. Therefore, this study aimed to identify the association between GNRI at admission and mortality outcomes of older trauma patients in the ICU.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Trauma Patients | – | Other: Death, Other: SurviveThe enrolled patients experienced trauma from different injuries and were hospitalized for treatment and admitted to the ICU. 700 older trauma patients (age equal to or more than 65 years) were finally included in the study. |
Who may qualify
- Ages
- 65 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- The medical records of 39,135 enrolled trauma patients registered between January 1, 2009 and December 31, 2019 were reviewed for this study (Figure 1). The enrolled patients experienced trauma from different injuries and were hospitalized for treatment. Of the 7,136 patients who were admitted to the ICU, 1,926 older trauma patients were aged ≥ 65 years. After excluding patients whose albumin data were not available and those with incomplete data (n = 1,226), 700 older trauma patients were finally included in the study. Detailed information of the study population was extracted from the Trauma Registry System of the hospital.
Key inclusion criteria (3 listed)
- trauma from different injuries
- hospitalized for treatment
- admitted to the ICU
Key exclusion criteria (2 listed)
- albumin data were not available
- patients with incomplete data
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 |
|---|---|---|
| DeathMortality group | Other | Trauma Patients |
| SurviveSurvival group | Other | Trauma Patients |
Primary outcome
Mortality outcome
Time frame: through study completion, an average of 1 month
Mortality outcome of older trauma patients in the ICU.
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 29 Sep 2020.
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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 Trauma Injury, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
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 2 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 29 Sep 2020. 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 Taiwan. 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?
Mortality outcome (time frame: through study completion, an average of 1 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 29 Sep 2020.