Isolated or Combined Use of NUTRIC Score and NRS-2002 to Predict Mortality in the Intensive Care Unit

November 29, 2023 updated by: Onur Kucuk, Ankara Ataturk Sanatorium Training and Research Hospital

Isolated or Combined Use of NUTRIC Score and NRS-2002 to Predict Mortality in Patients Admitted to the Intensive Care Unit for Respiratory Failure

The objective of this investigation was to assess the predictive capacity of the NUTRIC Score and NRS-2002, separately or combined, in forecasting hospital, 28-day and 3-month mortality in patients with respiratory failure admitted to the intensive care unit.

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

Malnutrition is a significant and widespread issue amongst hospitalized patients. Its prevalence is higher in critically ill patients who are admitted to Intensive Care Units (ICUs). Nutritional screening aims to estimate the probability of both positive and negative outcomes in patient treatment based on nutrition-related factors, and whether nutritional therapy can have a positive effect. The Nutritional Risk Score-2002 (NRS-2002) and Nutritional Risk Score in Critically Ill Patients (NUTRIC) are commonly used for nutritional risk assessment in critically ill patients. However, there is currently insufficient evidence in the literature to determine which scale should take precedence in the nutritional care protocol of critically ill patients with respiratory failure. Furthermore, there are no studies demonstrating the sensitivity of these scales varies based on the type of respiratory failure. This study aims to examine the effectiveness of the NUTRIC Score and NRS-2002, alone or combined, in predicting hospital, 28-day, and 3-month mortality in critically ill patients admitted to the intensive care unit with respiratory failure. Do the NUTRIC Score and NRS-2002 provide sufficient accuracy or is there a distinction when utilised singularly or together in forecasting mortality rates within the hospital, 28-day and 3-month time frames? Additionally, is there a defined threshold for predicting mortality in patients with respiratory failure when using the NUTRIC Score and NRS-2002 either by themselves or in conjunction? Does the efficacy of these prediction tools differ based on the type of respiratory failure?

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.
750

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

  • Turkey
    • Keçiören
      • Ankara, Keçiören, Turkey, 06290
        • Ankara Ataturk Sanatorium Training and Research 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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

All adult patients (aged ≥18) admitted to the Intensive Care Units at the Anesthesiology and Reanimation Clinic of Ankara Atatürk Sanatorium Training and Research Hospital with respiratory distress, who remain in ICU for over 72 hours and meet the study criteria, are included.

Description

Inclusion Criteria:

  • All patients aged 18 and over
  • Admission to the intensive care unit due to respiratory failure (respiratory distress is included in the complaints of patients when admitted to the intensive care unit).

Exclusion Criteria:

  • Patients diagnosed with neurodegenerative diseases (Alzheimer's disease and other dementia diseases, Parkinson's disease, Prion disease, Motor neuron diseases, Huntington's Disease, Spinocerebellar ataxia, Spinal muscular atrophy)
  • Pregnant patients
  • Patients with a length of stay in the ICU of less than 72 hours
  • Patients in the terminal period who were diagnosed with malignancy and whose treatment process was terminated due to lack of response to treatment.

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

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.
Survivors
Patients admitted to the intensive care unit due to respiratory failure with no mortality in the 3-month follow-up period
Other: mNUTRIC score
The mNUTRIC score is a useful means of gauging the nutritional risk of patients in intensive care. Originally designed for IC unit patients, the score is calculated even when patient cooperation is unfeasible, making it applicable for intubated patients. Information necessary for calculation can be obtained from the patient's kin. The mNUTRIC score (without IL-6) classifies patients according to predefined metrics. The following information is necessary: (1) the patient's age, (2) their APACHE II score, (3) their SOFA score, (4) their comorbidities, and (5) the number of days they were hospitalized before being admitted to ICU.
Other Names:
  • Modified Nutrition Risk in Critically Ill Score
Other: NRS-2002
The NRS-2002 score is a tool utilised to measure the nutritional risk of patients in intensive care units. This tool was specifically developed for the purpose of evaluating intensive care unit patients and can be calculated without requiring the patient's active involvement. Additionally, it can be applied to patients who have been intubated and the required information can be sourced from their family members or relatives. The Nutritional Risk Screening (NRS)-2002 assesses a patient's nutritional risk based on five variables: (1) recent unexplained weight loss, (2) appetite, (3) BMI, (4) disease-related stress factors (comorbidities), and (5) age over 70 years which is an additional risk factor.
Other Names:
  • Nutritional Risk Score-2002
Nonsurvivors
Patients who were admitted to the intensive care unit due to respiratory failure and mortality was observed in the 3-month follow-up period
Other: mNUTRIC score
The mNUTRIC score is a useful means of gauging the nutritional risk of patients in intensive care. Originally designed for IC unit patients, the score is calculated even when patient cooperation is unfeasible, making it applicable for intubated patients. Information necessary for calculation can be obtained from the patient's kin. The mNUTRIC score (without IL-6) classifies patients according to predefined metrics. The following information is necessary: (1) the patient's age, (2) their APACHE II score, (3) their SOFA score, (4) their comorbidities, and (5) the number of days they were hospitalized before being admitted to ICU.
Other Names:
  • Modified Nutrition Risk in Critically Ill Score
Other: NRS-2002
The NRS-2002 score is a tool utilised to measure the nutritional risk of patients in intensive care units. This tool was specifically developed for the purpose of evaluating intensive care unit patients and can be calculated without requiring the patient's active involvement. Additionally, it can be applied to patients who have been intubated and the required information can be sourced from their family members or relatives. The Nutritional Risk Screening (NRS)-2002 assesses a patient's nutritional risk based on five variables: (1) recent unexplained weight loss, (2) appetite, (3) BMI, (4) disease-related stress factors (comorbidities), and (5) age over 70 years which is an additional risk factor.
Other Names:
  • Nutritional Risk Score-2002

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
Time Frame: 3 month
Mortality data of patients admitted to the intensive care unit due to respiratory failure during 3-month follow-up period
3 month

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
mNUTRIC score
Time Frame: 72 hours
The mNUTRIC score is a useful means of gauging the nutritional risk of patients in intensive care. Originally designed for IC unit patients, the score is calculated even when patient cooperation is unfeasible, making it applicable for intubated patients. Information necessary for calculation can be obtained from the patient's kin. The mNUTRIC score (without IL-6) classifies patients according to predefined metrics. The following information is necessary: (1) the patient's age, (2) their APACHE II score, (3) their SOFA score, (4) their comorbidities, and (5) the number of days they were hospitalized before being admitted to ICU.
72 hours
NRS-2002 score
Time Frame: 72 hours
The NRS-2002 score is a tool utilised to measure the nutritional risk of patients in intensive care units. This tool was specifically developed for the purpose of evaluating intensive care unit patients and can be calculated without requiring the patient's active involvement. Additionally, it can be applied to patients who have been intubated and the required information can be sourced from their family members or relatives. The Nutritional Risk Screening (NRS)-2002 assesses a patient's nutritional risk based on five variables: (1) recent unexplained weight loss, (2) appetite, (3) BMI, (4) disease-related stress factors (comorbidities), and (5) age over 70 years which is an additional risk factor.
72 hours

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.
Ankara Ataturk Sanatorium Training and Research Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Onur KÜÇÜK, specialist, Ankara Ataturk Sanatorium Training and Research 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.
February 10, 2023

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.
August 10, 2023

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.
November 10, 2023

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).
October 30, 2023

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.
October 30, 2023

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.
November 3, 2023

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.
December 1, 2023

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.
November 29, 2023

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.
November 1, 2023

More Information

Terms related to this study

Keywords

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.
  • 2012-KAEK-15/2627

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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