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
About this trial
This is an interventional screening trial for Malnutrition
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
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
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
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Assessing Nutritional Status in Patients With Sepsis
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