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Assessing Nutritional Status in Patients With Sepsis

Primary Purpose

Malnutrition

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
NRS 2002, nutric, SGA and adductor pollicis
Sponsored by
Trakya University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Malnutrition

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm Type

    Active Comparator

    Placebo Comparator

    Placebo Comparator

    Placebo Comparator

    Arm Label

    nutric score

    adductor pollicis

    SGA score

    NRS 2002 score

    Arm Description

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

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

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

    > 3 indicates high risk for malnutrition

    Outcomes

    Primary Outcome Measures

    to understand the best malnutrition screening test
    Our aim was to access which malnutrition test was the best

    Secondary Outcome Measures

    Full Information

    First Posted
    December 17, 2018
    Last Updated
    April 5, 2019
    Sponsor
    Trakya University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03906266
    Brief Title
    Assessing Nutritional Status in Patients With Sepsis
    Official Title
    Comparison of the Efficacy of Adductor Pollicis, NRS 2002, Nutric and SGD Tests in Assessing Nutritional Status in Patients With Sepsis
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2019
    Overall Recruitment Status
    Completed
    Study Start Date
    June 15, 2016 (Actual)
    Primary Completion Date
    June 15, 2017 (Actual)
    Study Completion Date
    December 15, 2017 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Trakya University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Product Manufactured in and Exported from the U.S.
    No
    Data Monitoring Committee
    No

    5. Study Description

    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.
    Detailed Description
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Malnutrition

    7. Study Design

    Primary Purpose
    Screening
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Model Description
    tests for understanding nutritional deficiency will be compared in a single patient group
    Masking
    Investigator
    Masking Description
    tests are made by different persons
    Allocation
    Non-Randomized
    Enrollment
    287 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    nutric score
    Arm Type
    Active Comparator
    Arm Description
    > 5 indicates high risk for malnutrition < 4 indicates low risk for malnutrition
    Arm Title
    adductor pollicis
    Arm Type
    Placebo Comparator
    Arm Description
    < 20 mm indicates high high risk for malnutrition > 20 mm indicates low risk for malnutrition
    Arm Title
    SGA score
    Arm Type
    Placebo Comparator
    Arm Description
    SGA 1 indicates no malnutrition SGA 2 indicates good diet SGA 3 indicates high risk for malnutrition
    Arm Title
    NRS 2002 score
    Arm Type
    Placebo Comparator
    Arm Description
    > 3 indicates high risk for malnutrition
    Intervention Type
    Diagnostic Test
    Intervention Name(s)
    NRS 2002, nutric, SGA and adductor pollicis
    Intervention Description
    NRS 2002, nutric, SGA and adductor pollicis tests detects the malnutrition
    Primary Outcome Measure Information:
    Title
    to understand the best malnutrition screening test
    Description
    Our aim was to access which malnutrition test was the best
    Time Frame
    18 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    90 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Assessing Nutritional Status in Patients With Sepsis

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