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

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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

  • Taiwan
      • Kaohsiung, Taiwan, 83301
        • Kaohsiung Chang Gung Memorial Hospital

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

61 years to 96 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

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
Other: Death
Mortality group
Other: Survive
Survival group

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Chang Gung Memorial Hospital

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 7, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 14, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 20, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 21, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 26, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 29, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 29, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 26, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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