- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06115525
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
Completed
Conditions
Intervention / Treatment
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
Observational
Enrollment (Actual)
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
-
-
Keçiören
-
Ankara, Keçiören, Turkey, 06290
- Ankara Atatürk 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
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 |
Intervention / Treatment |
---|---|
Survivors
Patients admitted to the intensive care unit due to respiratory failure with no mortality in the 3-month follow-up period
|
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:
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:
|
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
|
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:
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:
|
What is the study measuring?
Primary Outcome Measures
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
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.
Investigators
- Principal Investigator: Onur KÜÇÜK, specialist, Ankara Atatürk 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)
February 10, 2023
Primary Completion (Actual)
August 10, 2023
Study Completion (Actual)
November 10, 2023
Study Registration Dates
First Submitted
October 30, 2023
First Submitted That Met QC Criteria
October 30, 2023
First Posted (Actual)
November 3, 2023
Study Record Updates
Last Update Posted (Actual)
December 1, 2023
Last Update Submitted That Met QC Criteria
November 29, 2023
Last Verified
November 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID 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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