- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06946537
Nutritional Status and Patient Characteristics Upon Length of Stay, Clinical Outcome, and Survival in Older Hospitalized Patients (INSIGHT)
The Influence of Nutritional Status and Phenotypic Characteristics Upon Length of Stay, Clinical Outcome, and Survival in Hospitalized Patients
Disease-related malnutrition (DRM) describes undernutrition or imbalances in energy, protein, or other nutrient-needs, caused by a concomitant disease. Nutritional status plays a vital role in the fate of hospitalized patients, and DRM is associated with loss of function and decreased survival.
DRM is a common condition in patients with acute illnesses, approximately 30% among medical inpatients are malnourished when admitteed to the hospital, and rise higher among the older or critically ill. Physiologically malnutrition is associated with a) poorer tissue healing and restitution after severe disease, b) suppressed immune function and resistance towards infections, c) poorer metabolic defense towards critical disease, d) delayed and poorer progress of chronic diseases. In addition, inadequate nutrition is coupled to a prolonged hospital stay, resulting in more readmissions, and overall higher mortality in hospital patients. Yet, nutritional status of patients upon hospital admittance is seldom systematically assessed and the consequences of DRM in older acutely admitted patients still needs to be understood.
This project will provide a detailed description of nutritional, physiolgical, and biochemical status of 1500 acutely admitted patients. In relation, the study will investigate the relation between patient characteristics and disease progression. The obtained data will also be coupled to patient registers to investigate the link between length of hospital stay, readmissions and acute contact, and mortality.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Jacob B Jespersen, MSc
- Phone Number: +4522321355
- Email: jacob.baekgaard.jespersen@regionh.dk
Study Locations
-
-
-
Copenhagen, Denmark, 2400
- Recruiting
- Bispebjerg Hospital
-
Contact:
- Jacob Jespersen
- Phone Number: +4522321355
- Email: jacob.baekgaard.jespersen@regionh.dk
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Acutely admitted adults aged 65 years and above.
- Be able to comply with the study information, as assessed by the research personnel.
- Be able to understand Danish.
Exclusion Criteria:
- <24 hours admission
- Terminal illness in end stage of life
- Patients with temporary civil person registration number (CPR)
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
The INSIGHT cohort
A geriatric cohort (age ≥ 65) established to investigate the coupling of phenotypical characteristics to nutritional and physiological status.
The study intent to explore whether Disease-Related Malnutrition provides predictive value for patient prognosis based on specific phenotypic characteristics and establish different physiological stratifications to improve the identification of acutely admitted patients.
|
Anthropometry, Body composition (BIA), Nutritional screening (GLIM, SNAQ, NIS, NRS-2002), Functional tests, Seisomocardiography, Muscle strength, Blood tests, Fecal swabs, Indirect calorimetry Orientation-Memory-Concentration (OMC), Sarcopenia, Frailty (Clinical Frailty Scale), Comobidity, Polypharmacy, Portrait photo.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Length of Hospital Stay
Time Frame: From date of hospital admission untill discharge, assessed up to 2 months
|
Time (in hours) hospitalized from arrival to discharge
|
From date of hospital admission untill discharge, assessed up to 2 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Mortality
Time Frame: Time to mortality 90 days from index admission
|
Time to mortality from index admission
|
Time to mortality 90 days from index admission
|
|
Readmission
Time Frame: Time to readmission 30 days from discharge
|
Time to readmission from discharge
|
Time to readmission 30 days from discharge
|
|
Acute contact
Time Frame: Time to acute contact 30 days from discharge
|
Time to acute contact from discharge
|
Time to acute contact 30 days from discharge
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
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
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- H-25009586
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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.
Clinical Trials on Malnutrition
-
HAN University of Applied SciencesFrieslandCampina; HAS Hogeschool; Centre of Expertise Food (CoE Food); SligroCompletedMalnutrition; Protein | Protein MalnutritionNetherlands
-
Mairaj NoorCompletedMalnutrition (Calorie) | Protein-energy MalnutritionPakistan
-
University of ExeterRecruitingMalnutrition Elderly | Protein MalnutritionUnited Kingdom
-
Centre hospitalier Henri Mondor d'AurillacNot yet recruitingMalnutrition Severe | Malnutrition; ModerateFrance
-
Erasmus Medical CenterNot yet recruitingMalnutrition or Risk of MalnutritionNetherlands
-
International Centre for Diarrhoeal Disease Research...GlaxoSmithKline; Stanford UniversityCompletedMalnutrition | Malnutrition in Children | Child MalnutritionBangladesh
-
University of Nove de JulhoUnknownMalnutrition, ChildBrazil
-
Aga Khan UniversityAction Contre la FaimCompletedEvaluation of the Effectiveness and Impact of Community Case Management of Severe Acute MalnutritionSevere MalnutritionPakistan
-
University of California, San FranciscoThrasher Research Fund; Centre de Recherche en Sante de Nouna, Burkina FasoRecruitingAnemia | Malnutrition, Child | Malnutrition, Infant | Hemoglobin Level Measurement | Malnutrition or Risk of MalnutritionBurkina Faso
-
UNICEFSave the ChildrenCompletedSevere MalnutritionCongo, The Democratic Republic of the
Clinical Trials on Exposures and measurements
-
Centre des Sciences du Goût et de l'AlimentationEuropean Community; Regional Council of BurgundyCompletedConditioning of Caloric Adjustment and Liking in ChildrenFrance
-
Peking University Third HospitalEnrolling by invitationFemoroacetabular ImpingementChina
-
National Institute of Allergy and Infectious Diseases...RecruitingInflammatory | AllergicUnited States
-
Johns Hopkins UniversityCompletedPancreatic Cancer | Neoplastic Cells, Circulating | Biological MarkersUnited States
-
Hospices Civils de LyonCompletedInterstitial Lung Disease | Occupational ExposureFrance
-
Boston UniversityEunice Kennedy Shriver National Institute of Child Health and Human Development... and other collaboratorsRecruitingCOVID-19 | Influenza | SARS-COV-2 Infection | Infant Morbidity | Perinatal Morbidity | Other Respiratory VirusesUnited States, India
-
RenJi HospitalRecruiting
-
Inova MedicalMerck Sharp & Dohme LLCRecruitingPost-Acute COVID-19 SyndromeBrazil
-
AspetarCompletedImmobilization, Tonic | Hot Weather; Adverse EffectQatar