NCT06115525

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
750

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 10, 2023

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 10, 2023

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

October 30, 2023

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 3, 2023

Completed
7 days until next milestone

Study Completion

Last participant's last visit for all outcomes

November 10, 2023

Completed
Last Updated

December 1, 2023

Status Verified

November 1, 2023

Enrollment Period

6 months

First QC Date

October 30, 2023

Last Update Submit

November 29, 2023

Conditions

Keywords

mNUTRICNRS-2002Respiratory FailureIntensive Care UnitNutrition

Outcome Measures

Primary Outcomes (1)

  • Mortality

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

    3 month

Secondary Outcomes (2)

  • mNUTRIC score

    72 hours

  • NRS-2002 score

    72 hours

Study Arms (2)

Survivors

Patients admitted to the intensive care unit due to respiratory failure with no mortality in the 3-month follow-up period

Other: mNUTRIC scoreOther: 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

Other: mNUTRIC scoreOther: NRS-2002

Interventions

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.

Also known as: Modified Nutrition Risk in Critically Ill Score
NonsurvivorsSurvivors

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.

Also known as: Nutritional Risk Score-2002
NonsurvivorsSurvivors

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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).

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ankara Atatürk Sanatorium Training and Research Hospital

Ankara, Keçiören, 06290, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Nutrition DisordersMalnutritionRespiratory Insufficiency

Condition Hierarchy (Ancestors)

Nutritional and Metabolic DiseasesRespiration DisordersRespiratory Tract Diseases

Study Officials

  • Onur KÜÇÜK, specialist

    Ankara Ataturk Sanatorium Training and Research Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Department of anesthesiology and reanimation, Principal Investigator, Specialist Doctor

Study Record Dates

First Submitted

October 30, 2023

First Posted

November 3, 2023

Study Start

February 10, 2023

Primary Completion

August 10, 2023

Study Completion

November 10, 2023

Last Updated

December 1, 2023

Record last verified: 2023-11

Data Sharing

IPD Sharing
Will not share

Locations