- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03906266
Assessing Nutritional Status in Patients With Sepsis
Comparison of the Efficacy of Adductor Pollicis, NRS 2002, Nutric and SGD Tests in Assessing Nutritional Status in Patients With Sepsis
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.
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: SCREENING
- Allocation: NON_RANDOMIZED
- Interventional Model: SINGLE_GROUP
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
ACTIVE_COMPARATOR: nutric score
> 5 indicates high risk for malnutrition < 4 indicates low risk for malnutrition
|
NRS 2002, nutric, SGA and adductor pollicis tests detects the malnutrition
|
PLACEBO_COMPARATOR: adductor pollicis
< 20 mm indicates high high risk for malnutrition > 20 mm indicates low risk for malnutrition
|
NRS 2002, nutric, SGA and adductor pollicis tests detects the malnutrition
|
PLACEBO_COMPARATOR: SGA score
SGA 1 indicates no malnutrition SGA 2 indicates good diet SGA 3 indicates high risk for malnutrition
|
NRS 2002, nutric, SGA and adductor pollicis tests detects the malnutrition
|
PLACEBO_COMPARATOR: NRS 2002 score
> 3 indicates high risk for malnutrition
|
NRS 2002, nutric, SGA and adductor pollicis tests detects the malnutrition
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
to understand the best malnutrition screening test
Time Frame: 18 months
|
Our aim was to access which malnutrition test was the best
|
18 months
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- TÜTF-BAEK 2016/146
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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