Nutrition DisordersNCT06115525
Isolated or Combined Use of NUTRIC Score and NRS-2002 to Predict Mortality in the Intensive Care Unit
An observational study of Nutrition Disorders and Malnutrition, run by Ankara Ataturk Sanatorium Training and Research Hospital at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Nutrition Disorders, Malnutrition, Mortality
- What is being tested?
- mNUTRIC score and NRS-2002
- How many people
- 750 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 Feb 2023to 10 Nov 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ankara Atatürk Sanatorium Training and Research Hospital
Ankara, Keçiören, 06290
About this study
Official title: 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.
Read the 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?
- Conditions
- Nutrition Disorders, Malnutrition, Mortality
- Being tested
- mNUTRIC score, NRS-2002
- Keywords
- mNUTRIC, NRS-2002, Respiratory Failure, Intensive Care Unit, Nutrition
- Medical subject headings
- Nutrition Disorders, Malnutrition, Respiratory Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mNUTRIC scoreOther
Also called Modified Nutrition Risk in Critically Ill 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-2002Other
Also called Nutritional Risk Score-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.
| Study group | Role | What they receive |
|---|---|---|
| Survivors | Patients admitted to the intensive care unit due to respiratory failure with no mortality in the 3-month follow-up period Receives: Other: mNUTRIC score; Other: NRS-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 Receives: Other: mNUTRIC score; Other: NRS-2002 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality
Mortality data of patients admitted to the intensive care unit due to respiratory failure during 3-month follow-up period
Measured: 3 month
Secondary outcomes (2)
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.
Measured: 72 hours
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.
Measured: 72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2023
- Study start10 Feb 2023
- Primary completion10 Aug 2023
- Study completion10 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nutrition DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 750 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ankara Ataturk Sanatorium Training and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Onur Kucuk, Ankara Ataturk Sanatorium Training and Research Hospital
- Investigators
- Onur KÜÇÜK, specialist, Principal investigator, Ankara Ataturk Sanatorium Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06115525
- Sponsor's protocol ID
- 2012-KAEK-15/2627
- Status last verified
- Nov 2023
- First submitted
- 30 Oct 2023
- Last updated
- 1 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Isolated or Combined Use of NUTRIC Score and NRS-2002 to Predict Mortality in Patients Admitted to the Intensive Care Unit for Respiratory Failure
- ClinicalTrials.gov ID
- NCT06115525
- Acronym / sponsor ID
- 2012-KAEK-15/2627
- Conditions
- Nutrition Disorders, Malnutrition, Mortality
- Keywords
- mNUTRIC, NRS-2002, Respiratory Failure, Intensive Care Unit, Nutrition
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 750 participants (actual)
- Lead sponsor
- Ankara Ataturk Sanatorium Training and Research HospitalOther government
- Study start
- 10 Feb 2023 (actual)
- Primary completion
- 10 Aug 2023 (actual)
- Study completion
- 10 Nov 2023 (actual)
- First posted
- 3 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Survivors | – | Other: mNUTRIC score, Other: NRS-2002Patients admitted to the intensive care unit due to respiratory failure with no mortality in the 3-month follow-up period |
| Nonsurvivors | – | Other: mNUTRIC score, Other: NRS-2002Patients who were admitted to the intensive care unit due to respiratory failure and mortality was observed in the 3-month follow-up period |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- 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).
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| mNUTRIC scoreAlso: Modified Nutrition Risk in Critically Ill ScoreThe 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 | Nonsurvivors, Survivors |
| NRS-2002Also: Nutritional Risk Score-2002The 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 | Nonsurvivors, Survivors |
Primary outcome
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
2 secondary outcomes
mNUTRIC score
Time frame: 72 hours
NRS-2002 score
Time frame: 72 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Dec 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Onur KÜÇÜK, specialist principal investigator
Ankara Ataturk Sanatorium Training and Research Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Nutrition Disorders and Malnutrition, run by Ankara Ataturk Sanatorium Training and Research Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mortality (time frame: 3 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Dec 2023.