MalnutritionAMASINNCT05918900
Analyses of Malnutrition Screening in Internal Medicine
An observational study of Malnutrition, run by University Medicine Greifswald at 1 site in Germany.
Trial summary
The goal of this observational study is to study the presence and consequences of malnutrition risk in hospitalized internal medicine patients. The main questions it aims to answer are: 1. How many patients are at risk of malnutrition at admission? 2. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Malnutrition
- How many people
- 323 participants
- Where
- 1 siteGermany
- Study dates
- 5 Jun 2023to 22 Sep 2023
- 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
- No healthy volunteers
- Adult, Older adult
Study population: Patients will be recruited at University Medicine Greifswald (Northeast Germany). Internal medicine patients with any gastrointestinal, endocrine, rheumatic, or nephrological disease admitted to the hospital will be identified in the respective wards and will be approached for study inclusion.
Who may be able to join
- hospital admission for gastrointestinal, endocrine, rheumatic, or nephrological condition
- provision of informed consent
Who cannot join
- inability to provide consent
- unfeasibility to perform malnutrition screening within 48h after admission
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Descriptive and Comparative Analyses of Malnutrition Screening in Internal Medicine
The goal of this observational study is to study the presence and consequences of malnutrition risk in hospitalized internal medicine patients.
The main questions it aims to answer are:
Read more
- How many patients are at risk of malnutrition at admission?
- Is there a link between an existing malnutrition risk and nutrition therapy that the patients receive?
- Is there a link between an existing malnutrition risk and clinical outcome (e.g. length of hospital stay, mortality, need for rehospitalization)?
Participants will be screened for malnutrition risk at admission using a validated questionnaire (Nutritional Risk Screening 2002). All relevant data regarding hospital stay will be obtained from the clinical information system after discharge.
Read the detailed description
Malnutrition is associated with adverse clinical outcome in hospitalized patients. Therefore, systematic screening for malnutrition risk at admission is recommended by almost all medical expert societies to identify patients who will benefit from nutritional therapy.
Although clinical and economic benefit of systematic malnutrition screening have been shown in various settings and for different patient groups, such screening is still not mandatory in most countries. In part, establishment of malnutrition screening is hampered by discrepant findings on the prevalence of malnutrition risk and the lack of evidence on a local level.
Hence, in this observational study the investigators examine the results of systematic malnutrition screening in internal medicine patients admitted to a university hospital in Northeast Germany. In particular, the investigators aim to determine the prevalence of malnutrition risk at hospital admission, the association between malnutrition risk and nutrition therapy as well as clinical outcome in different disciplines of internal medicine.
For this purpose, all patients undergo screening for malnutrition risk at admission using a validated instrument (Nutritional Risk Screening 2002). All relevant data regarding the patients' hospital stay will be obtained from the clinical information system after discharge.
- Conditions
- Malnutrition
- Keywords
- Malnutrition risk, Screening, Internal medicine, Nutritional Risk Screening 2002, Gastroenterology, Nephrology, Endocrinology, Rheumatology
- Medical subject headings
- Malnutrition
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall presence of malnutrition risk
Prevalence of malnutrition risk, i.e. Nutritional Risk Screening 2002 (NRS-2002) score >= 3 points, in all internal medicine patients at hospital admission. NRS-2002 score ranges from 0 to 7, with higher values indicating greater nutritional risk.
Measured: Baseline
Secondary outcomes (12)
Presence of malnutrition risk in gastroenterology
Prevalence of malnutrition risk, i.e. Nutritional Risk Screening 2002 (NRS-2002) score >= 3 points, in patients with gastrointestinal disease at hospital admission. NRS-2002 score ranges from 0 to 7, with higher values indicating greater nutritional risk.
Measured: Baseline
Presence of malnutrition risk in endocrinology
Prevalence of malnutrition risk, i.e. Nutritional Risk Screening 2002 (NRS-2002) score >= 3 points, in patients with endocrine disease at hospital admission. NRS-2002 score ranges from 0 to 7, with higher values indicating greater nutritional risk.
Measured: Baseline
Presence of malnutrition risk in rheumatology
Prevalence of malnutrition risk, i.e. Nutritional Risk Screening 2002 (NRS-2002) score >= 3 points, in patients with rheumatic disease at hospital admission. NRS-2002 score ranges from 0 to 7, with higher values indicating greater nutritional risk.
Measured: Baseline
Presence of malnutrition risk in nephrology
Prevalence of malnutrition risk, i.e. Nutritional Risk Screening 2002 (NRS-2002) score >= 3 points, in patients with nephrological disease at hospital admission. NRS-2002 score ranges from 0 to 7, with higher values indicating greater nutritional risk.
Measured: Baseline
Relation of malnutrition risk to nutritional consultation
Association between malnutrition risk, i.e. Nutritional Risk Screening 2002 (NRS-2002) score >= 3 points, and number of nutritional consultations. NRS-2002 score ranges from 0 to 7, with higher values indicating greater nutritional risk.
Measured: Baseline
Relation of malnutrition risk to nutritional diagnosis
Association between malnutrition risk, i.e. Nutritional Risk Screening 2002 (NRS-2002) score >= 3 points, and nutritional diagnosis resulting from nutritional assessment by an expert dietitian. NRS-2002 score ranges from 0 to 7, with higher values indicating greater nutritional risk.
Measured: Baseline
Relation of malnutrition risk to intensive care treatment
Association between malnutrition risk, i.e. Nutritional Risk Screening 2002 (NRS-2002) score >= 3 points, and admission to an intensive care unit. NRS-2002 score ranges from 0 to 7, with higher values indicating greater nutritional risk.
Measured: Baseline
Relation of malnutrition risk to intermediate care treatment
Association between malnutrition risk, i.e. Nutritional Risk Screening 2002 (NRS-2002) score >= 3 points, and admission to an intermediate care unit. NRS-2002 score ranges from 0 to 7, with higher values indicating greater nutritional risk.
Measured: Baseline
Relation of malnutrition risk to mortality
Association between malnutrition risk, i.e. Nutritional Risk Screening 2002 (NRS-2002) score >= 3 points, and in-hospital mortality. NRS-2002 score ranges from 0 to 7, with higher values indicating greater nutritional risk.
Measured: Baseline
Relation of malnutrition risk to length of hospital stay
Association between malnutrition risk, i.e. Nutritional Risk Screening 2002 (NRS-2002) score >= 3 points, and length of hospital stay measured in days. NRS-2002 score ranges from 0 to 7, with higher values indicating greater nutritional risk.
Measured: Baseline
Relation of malnutrition risk and 30-day readmission
Association between malnutrition risk, i.e. Nutritional Risk Screening 2002 (NRS-2002) score >= 3 points, and unplanned hospital readmission within 30 days after discharge. NRS-2002 score ranges from 0 to 7, with higher values indicating greater nutritional risk.
Measured: Baseline
Relation of malnutrition risk and 90-day readmission
Association between malnutrition risk, i.e. Nutritional Risk Screening 2002 (NRS-2002) score >= 3 points, and unplanned hospital readmission within 90 days after discharge. NRS-2002 score ranges from 0 to 7, with higher values indicating greater nutritional risk.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2023
- Study start5 Jun 2023
- Primary completion22 Sep 2023
- Study completion22 Sep 2023
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.
- 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
- Other
- Time perspective
- Prospective
- Enrolment
- 323 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Medicine Greifswald
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ali A Aghdassi, Professor, Principal investigator, University Medicine Greifswald
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05918900
- Sponsor's protocol ID
- BB 073/23
- Acronym
- AMASIN
- Status last verified
- Dec 2023
- First submitted
- 15 Jun 2023
- Last updated
- 8 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Descriptive and Comparative Analyses of Malnutrition Screening in Internal Medicine
- ClinicalTrials.gov ID
- NCT05918900
- Acronym / sponsor ID
- AMASIN / BB 073/23
- Conditions
- Malnutrition
- Keywords
- Malnutrition risk, Screening, Internal medicine, Nutritional Risk Screening 2002, Gastroenterology, Nephrology, Endocrinology, Rheumatology
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 323 participants (actual)
- Lead sponsor
- University Medicine GreifswaldUniversity, hospital or other
- Study start
- 5 Jun 2023 (actual)
- Primary completion
- 22 Sep 2023 (actual)
- Study completion
- 22 Sep 2023 (actual)
- First posted
- 26 Jun 2023 (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.
The goal of this observational study is to study the presence and consequences of malnutrition risk in hospitalized internal medicine patients.
The main questions it aims to answer are:
- How many patients are at risk of malnutrition at admission?
- Is there a link between an existing malnutrition risk and nutrition therapy that the patients receive?
- Is there a link between an existing malnutrition risk and clinical outcome (e.g. length of hospital stay, mortality, need for rehospitalization)?
Participants will be screened for malnutrition risk at admission using a validated questionnaire (Nutritional Risk Screening 2002). All relevant data regarding hospital stay will be obtained from the clinical information system after discharge.
Detailed description
Malnutrition is associated with adverse clinical outcome in hospitalized patients. Therefore, systematic screening for malnutrition risk at admission is recommended by almost all medical expert societies to identify patients who will benefit from nutritional therapy.
Although clinical and economic benefit of systematic malnutrition screening have been shown in various settings and for different patient groups, such screening is still not mandatory in most countries. In part, establishment of malnutrition screening is hampered by discrepant findings on the prevalence of malnutrition risk and the lack of evidence on a local level.
Hence, in this observational study the investigators examine the results of systematic malnutrition screening in internal medicine patients admitted to a university hospital in Northeast Germany. In particular, the investigators aim to determine the prevalence of malnutrition risk at hospital admission, the association between malnutrition risk and nutrition therapy as well as clinical outcome in different disciplines of internal medicine.
For this purpose, all patients undergo screening for malnutrition risk at admission using a validated instrument (Nutritional Risk Screening 2002). All relevant data regarding the patients' hospital stay will be obtained from the clinical information system after discharge.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients will be recruited at University Medicine Greifswald (Northeast Germany). Internal medicine patients with any gastrointestinal, endocrine, rheumatic, or nephrological disease admitted to the hospital will be identified in the respective wards and will be approached for study inclusion.
Key inclusion criteria (2 listed)
- hospital admission for gastrointestinal, endocrine, rheumatic, or nephrological condition
- provision of informed consent
Key exclusion criteria (2 listed)
- inability to provide consent
- unfeasibility to perform malnutrition screening within 48h after admission
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
Overall presence of malnutrition risk
Time frame: Baseline
Prevalence of malnutrition risk, i.e. Nutritional Risk Screening 2002 (NRS-2002) score >= 3 points, in all internal medicine patients at hospital admission. NRS-2002 score ranges from 0 to 7, with higher values indicating greater nutritional risk.
12 secondary outcomes
Presence of malnutrition risk in gastroenterology
Time frame: Baseline
Presence of malnutrition risk in endocrinology
Time frame: Baseline
Presence of malnutrition risk in rheumatology
Time frame: Baseline
Presence of malnutrition risk in nephrology
Time frame: Baseline
Relation of malnutrition risk to nutritional consultation
Time frame: Baseline
Relation of malnutrition risk to nutritional diagnosis
Time frame: Baseline
Relation of malnutrition risk to intensive care treatment
Time frame: Baseline
Relation of malnutrition risk to intermediate care treatment
Time frame: Baseline
Relation of malnutrition risk to mortality
Time frame: Baseline
Relation of malnutrition risk to length of hospital stay
Time frame: Baseline
Relation of malnutrition risk and 30-day readmission
Time frame: Baseline
Relation of malnutrition risk and 90-day readmission
Time frame: Baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 2023.
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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.
Ali A Aghdassi, Professor principal investigator
University Medicine Greifswald
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 University Medicine Greifswald at 1 site in Germany.
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 2 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: finished, as of the sponsor's last update on 8 Dec 2023. 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 Germany. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall presence of malnutrition risk (time frame: Baseline). 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 8 Dec 2023.