MalnutritionNCT03408067
Evaluation of the Efficacy of Nutritional Risk Screening Tests, NRS 2002 and SGA, to Identifying Malnourished Patients
An observational study of Malnutrition, run by Federico II University at 1 site in Italy.
Trial summary
In several hospital clinical trials, the nutritional intervention has been proven to be effective in preventing and/or reducing malnutrition. Therefore, a procedure to identify the risk of malnutrition or malnourishment in hospitalized patients is necessary to guarantee an adequate and timely nutritional treatment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Malnutrition
- How many people
- 200 participants
- Where
- 1 siteItaly
- Study dates
- Sep 2016to Sep 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Study population: Hospital Wards inpatients
Who may be able to join
- Age: ≥ 18 years.
Who cannot join
- Inpatients of the intensive care unit after admission from Emergency Room;
- Pregnancy and breastfeeding.
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Fabrizio Pasanisi
Naples, 80131
Franco Contaldo, MD, 00390817464747, contaldo@unina.it
About this study
Official title: "Evaluation of the Efficacy of Two Nutritional Risk Screening Tests, Nutritional Risk Screening 2002 (NRS 2002) and Subjective Global Assessment (SGA), to Identifying Malnourished or at Risk of Malnutrition Hospital Patients"
In several hospital clinical trials, the nutritional intervention has been proven to be effective in preventing and/or reducing malnutrition. Therefore, a procedure to identify the risk of malnutrition or malnourishment in hospitalized patients is necessary to guarantee an adequate and timely nutritional treatment.
Aims: to compare two validated nutritional screening tools: NRS 2002 and SGA. These are used to identify the risk of malnutrition or malnourishment in hospitalized patients.
Patients and Methods: The study is currently carried out at the Federico II University Hospital of Naples, Italy. The in patients admitted in the Clinical Wards since September 2016 are being evaluated. The two screening test results and the assessment of the patients' parameters are collected within 72 hours following admission. Age, sex, height, weight, Body Mass Index (BMI), calf circumference and dominant hand of the participants are being noted. Venous blood samples are collected for routine biochemistry and inflammatory parameters ; all measurements are determined by routine laboratory methods at the Department of Laboratory Medicine of the University Hospital Federico II, Naples.
Read the detailed description
In several hospital clinical trials, the nutritional intervention has been proven to be effective in preventing and/or reducing malnutrition. Therefore, a procedure to identify the risk of malnutrition or malnourishment in hospitalized patients is necessary to guarantee an adequate and timely nutritional treatment. It is mandatory for clinics and health services to perform the screening test for the evaluation of the nutritional status and need in hospitalized patient.
Aims: The first aim of this study is to compare two validated nutritional screening tools: Nutritional Risk Screening 2002 (NRS 2002) and Subjective Global Assessment (SGA). These are used to identify the risk of malnutrition or malnourishment in hospitalized patients. The second aim is to evaluate possible correlations between the tests score and body composition parameters (phase angle of the Bioelectrical Impedance Analysis, BIA), handgrip strength and biochemical parameters.
Patients and Methods: The study is currently carried out at the Federico II University Hospital of Naples, Italy. The inpatients admitted in the Clinical Wards coming from the Emergency Room of the Hospital since September 2016 are being evaluated. The two screening test results and the assessment of the patients' parameters are collected within 72 hours following admission. The SGA and NRS 2002 are administered separately. Age, sex, height, weight, Body Mass Index (BMI), calf circumference and dominant hand of the participants are being noted. Venous blood samples are collected for routine biochemistry and inflammatory parameters (C-reactive protein, fibrinogen) early in the morning in the fasting state; all measurements are determined by routine laboratory methods at the Department of Laboratory Medicine of the University Hospital Federico II, Naples.
- Conditions
- Malnutrition
- Medical subject headings
- Malnutrition
What is being measured
The primary outcome is the main question the study is designed to answer.
malnutrition scored with NRS 2002 questionnaire
scoring scale (units 0-3) : 0 = nourished patient; 1 = mild malnutrition, 2 = moderate malnutrition, 3 = severe malnutrition
Measured: 5 minutes
malnutrition scored with SGA questionnaire
scoring scale (units a-c) : a = nourished patient; b = mildly malnourished; c = severely malnourished
Measured: 5 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2018
- Study startSep 2016
- Primary completionJan 2018
- Study completionSep 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MalnutritionStudies of the same condition, open and under way.
- More trials run by Federico II UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Federico II University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fabrizio Pasanisi, Federico II University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03408067
- Sponsor's protocol ID
- 164/16
- Status last verified
- Jan 2018
- First submitted
- 19 Dec 2017
- Last updated
- 23 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- "Evaluation of the Efficacy of Two Nutritional Risk Screening Tests, Nutritional Risk Screening 2002 (NRS 2002) and Subjective Global Assessment (SGA), to Identifying Malnourished or at Risk of Malnutrition Hospital Patients"
- ClinicalTrials.gov ID
- NCT03408067
- Acronym / sponsor ID
- 164/16
- Conditions
- Malnutrition
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Federico II UniversityUniversity, hospital or other
- Study start
- Sep 2016 (actual)
- Primary completion
- Jan 2018 (actual)
- Study completion
- Sep 2018 (estimated)
- First posted
- 23 Jan 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In several hospital clinical trials, the nutritional intervention has been proven to be effective in preventing and/or reducing malnutrition. Therefore, a procedure to identify the risk of malnutrition or malnourishment in hospitalized patients is necessary to guarantee an adequate and timely nutritional treatment.
Aims: to compare two validated nutritional screening tools: NRS 2002 and SGA. These are used to identify the risk of malnutrition or malnourishment in hospitalized patients.
Patients and Methods: The study is currently carried out at the Federico II University Hospital of Naples, Italy. The in patients admitted in the Clinical Wards since September 2016 are being evaluated. The two screening test results and the assessment of the patients' parameters are collected within 72 hours following admission. Age, sex, height, weight, Body Mass Index (BMI), calf circumference and dominant hand of the participants are being noted. Venous blood samples are collected for routine biochemistry and inflammatory parameters ; all measurements are determined by routine laboratory methods at the Department of Laboratory Medicine of the University Hospital Federico II, Naples.
Detailed description
In several hospital clinical trials, the nutritional intervention has been proven to be effective in preventing and/or reducing malnutrition. Therefore, a procedure to identify the risk of malnutrition or malnourishment in hospitalized patients is necessary to guarantee an adequate and timely nutritional treatment. It is mandatory for clinics and health services to perform the screening test for the evaluation of the nutritional status and need in hospitalized patient.
Aims: The first aim of this study is to compare two validated nutritional screening tools: Nutritional Risk Screening 2002 (NRS 2002) and Subjective Global Assessment (SGA). These are used to identify the risk of malnutrition or malnourishment in hospitalized patients. The second aim is to evaluate possible correlations between the tests score and body composition parameters (phase angle of the Bioelectrical Impedance Analysis, BIA), handgrip strength and biochemical parameters.
Patients and Methods: The study is currently carried out at the Federico II University Hospital of Naples, Italy. The inpatients admitted in the Clinical Wards coming from the Emergency Room of the Hospital since September 2016 are being evaluated. The two screening test results and the assessment of the patients' parameters are collected within 72 hours following admission. The SGA and NRS 2002 are administered separately. Age, sex, height, weight, Body Mass Index (BMI), calf circumference and dominant hand of the participants are being noted. Venous blood samples are collected for routine biochemistry and inflammatory parameters (C-reactive protein, fibrinogen) early in the morning in the fasting state; all measurements are determined by routine laboratory methods at the Department of Laboratory Medicine of the University Hospital Federico II, Naples.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Hospital Wards inpatients
Key inclusion criteria (1 listed)
- Age: ≥ 18 years.
Key exclusion criteria (2 listed)
- Inpatients of the intensive care unit after admission from Emergency Room;
- Pregnancy and breastfeeding.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
malnutrition scored with NRS 2002 questionnaire
Time frame: 5 minutes
scoring scale (units 0-3) : 0 = nourished patient; 1 = mild malnutrition, 2 = moderate malnutrition, 3 = severe malnutrition
malnutrition scored with SGA questionnaire
Time frame: 5 minutes
scoring scale (units a-c) : a = nourished patient; b = mildly malnourished; c = severely malnourished
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2018.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Malnutrition, run by Federico II University at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Fabrizio Pasanisi, MD (00390817464747, pasanisi@unina.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
malnutrition scored with NRS 2002 questionnaire (time frame: 5 minutes). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jan 2018.