Assessing Nutritional Status in Patients With Sepsis

NCT ID: NCT03906266

Last Updated: 2019-04-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

287 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-06-15

Study Completion Date

2017-12-15

Brief Summary

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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.

Detailed Description

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The majority of patients in the intensive care unit are diagnosed with sepsis. Malnutrition is frequently observed in these patients, and malnutrition can be detected by tests performed in patients such as NRS-2002, nutric and SGA. The parameters evaluated in the SGA test are: the investigatorsight loss in the last 6 months, the investigatorsight loss in the last 2 the investigatorseks, changes in oral intake, dietary changes, nausea, vomiting, diarrhea, functional capacity, subcutaneous fat evaluation, muscle loss assessment, edema and acid. All these parameters are evaluated with the help of a scale and the patient's malnutrition status is classified as A, B, C. Group A is mild, group B is medium and group C indicates heavy malnutrition. This test is a test that can be carried out at bedside. In the other test, NRS-2002, the patient is scored according to the patient's nutritional status and the severity of the disease. Here, the score is greater than ≥3 indicates that the patient is at risk of malnutrition. \<Less than 3 indicates that the patient should be screened once a the investigatorsek. In the measurement of adductor pollicis longus muscle thickness in recent years, adductor pollicis longus muscle thickness betthe investigatorsen the thumb and forefinger in the patient's dominant hand is measured. This value has been shown to be valuable in determining the malnutrition status of the studies.

In our study, the investigators aimed to investigate the efficacy of these three values 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. These tests will be carried out only once. All tests are painless procedures. Adductor pollicis longus muscle measuring apparatus is available in intensive care.

Conditions

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Malnutrition

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

tests for understanding nutritional deficiency will be compared in a single patient group
Primary Study Purpose

SCREENING

Blinding Strategy

SINGLE

Investigators
tests are made by different persons

Study Groups

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nutric score

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

Group Type ACTIVE_COMPARATOR

NRS 2002, nutric, SGA and adductor pollicis

Intervention Type DIAGNOSTIC_TEST

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

adductor pollicis

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

Group Type PLACEBO_COMPARATOR

NRS 2002, nutric, SGA and adductor pollicis

Intervention Type DIAGNOSTIC_TEST

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

SGA score

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

Group Type PLACEBO_COMPARATOR

NRS 2002, nutric, SGA and adductor pollicis

Intervention Type DIAGNOSTIC_TEST

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

NRS 2002 score

\> 3 indicates high risk for malnutrition

Group Type PLACEBO_COMPARATOR

NRS 2002, nutric, SGA and adductor pollicis

Intervention Type DIAGNOSTIC_TEST

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

Interventions

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NRS 2002, nutric, SGA and adductor pollicis

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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

under 18 years old over 90 years old patients who dot have sepsis
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Trakya University

OTHER

Sponsor Role lead

Responsible Party

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Prof Mehmet Turan Inal

Principal Investigator, Clinical Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Other Identifiers

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TÜTF-BAEK 2016/146

Identifier Type: -

Identifier Source: org_study_id

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