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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06115525
Other study ID # 2012-KAEK-15/2627
Secondary ID
Status Completed
Phase
First received
Last updated
Start date February 10, 2023
Est. completion date November 10, 2023

Study information

Verified date November 2023
Source Ankara Ataturk Sanatorium Training and Research Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.


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?


Recruitment information / eligibility

Status Completed
Enrollment 750
Est. completion date November 10, 2023
Est. primary completion date August 10, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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.
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.

Locations

Country Name City State
Turkey Ankara Atatürk Sanatorium Training and Research Hospital Ankara Keçiören

Sponsors (1)

Lead Sponsor Collaborator
Ankara Ataturk Sanatorium Training and Research Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary Mortality Mortality data of patients admitted to the intensive care unit due to respiratory failure during 3-month follow-up period 3 month
Secondary 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. 72 hours
Secondary NRS-2002 score 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
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