Assessing Nutritional Status in Patients With Sepsis

NCT03906266 | Completed

• 1 other identifier: TÜTF-BAEK 2016/146
• Study Type: interventional
• Target: 287
• Locations: 0 countries
• Sites: N/A

Brief Summary

In this study, the investigators aimed to investigate the efficacy of NRS-2002, SGA, nutric and adductor pollicis longus muscle thickness tests in patients with sepsis in intensive care unit. The patients will be diagnosed with sepsis according to 2013 sepsis diagnostic criteria. In these diagnostic criteria, the systemic inflammatory reaction syndrome criteria are fever\> 38.3 ° C or \<36 ° C,\> 12000 / mm3 or \<4000 / mm3, or more than 10% banded leucocytes, the respiratory rate is greater than 20 / min or In case of two suspected outbreaks\> 90 / min., or suspected infection or culture-proven infection, the patient will be diagnosed with sepsis. NRS-2002, nutric and SGA tests will be performed in all patients who are diagnosed with sepsis and are expected to stay in intensive care for more than 24 hours. Adductor pollicis longus muscle thickness will be measured in the same patients to understand the effectiveness of these tests on malnutrition. All tests are painless procedures. Adductor pollicis longus muscle measuring apparatus is available in intensive care.

Conditions

Malnutrition

Outcome Measures

Primary Outcomes (1)

• to understand the best malnutrition screening test

  Our aim was to access which malnutrition test was the best

  18 months

Study Arms (4)

nutric score

ACTIVE COMPARATOR

\> 5 indicates high risk for malnutrition \< 4 indicates low risk for malnutrition

Diagnostic Test: NRS 2002, nutric, SGA and adductor pollicis

adductor pollicis

PLACEBO COMPARATOR

\< 20 mm indicates high high risk for malnutrition \> 20 mm indicates low risk for malnutrition

Diagnostic Test: NRS 2002, nutric, SGA and adductor pollicis

SGA score

PLACEBO COMPARATOR

SGA 1 indicates no malnutrition SGA 2 indicates good diet SGA 3 indicates high risk for malnutrition

Diagnostic Test: NRS 2002, nutric, SGA and adductor pollicis

NRS 2002 score

PLACEBO COMPARATOR

\> 3 indicates high risk for malnutrition

Diagnostic Test: NRS 2002, nutric, SGA and adductor pollicis

Interventions

NRS 2002, nutric, SGA and adductor pollicis DIAGNOSTIC_TEST

NRS 2002, nutric, SGA and adductor pollicis tests detects the malnutrition

NRS 2002 score; SGA score; adductor pollicis; nutric score

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• patients in the ICU for more than 24 hours patients with sepsis

You may not qualify if:

• under 18 years old over 90 years old patients who dot have sepsis

Sponsors & Collaborators

• Trakya University: lead

MeSH Terms

Conditions

Malnutrition

Condition Hierarchy (Ancestors)

Nutrition Disorders; Nutritional and Metabolic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: tests are made by different persons
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, Clinical Professor

Model Details: tests for understanding nutritional deficiency will be compared in a single patient group

Study Record Dates

• First Submitted: December 17, 2018
• First Posted: April 8, 2019
• Study Start: June 15, 2016
• Primary Completion: June 15, 2017
• Study Completion: December 15, 2017
• Last Updated: April 8, 2019

Record last verified: 2019-04

Data Sharing

• IPD Sharing: Will not share