- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04567901
GNRI and Influence of Nutrition on the Mortality of Trauma Patients
September 26, 2020 updated by: Chang Gung Memorial Hospital
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).
Study Overview
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 Type
Observational
Enrollment (Actual)
700
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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-
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Kaohsiung, Taiwan, 83301
- Kaohsiung Chang Gung Memorial Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
63 years to 98 years (Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
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.
Description
Inclusion Criteria:
- trauma from different injuries
- hospitalized for treatment
- admitted to the ICU
Exclusion Criteria:
- albumin data were not available
- patients with incomplete data
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Case-Control
- Time Perspectives: Retrospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
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.
|
Mortality group
Survival group
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Mortality outcome
Time Frame: through study completion, an average of 1 month
|
Mortality outcome of older trauma patients in the ICU.
|
through study completion, an average of 1 month
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 7, 2020
Primary Completion (Actual)
September 14, 2020
Study Completion (Actual)
September 20, 2020
Study Registration Dates
First Submitted
September 21, 2020
First Submitted That Met QC Criteria
September 26, 2020
First Posted (Actual)
September 29, 2020
Study Record Updates
Last Update Posted (Actual)
September 29, 2020
Last Update Submitted That Met QC Criteria
September 26, 2020
Last Verified
September 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 202001446B0
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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