- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07473492
Assessment of Malnutrition in Hospitalized Patients: a Quasi Study (AMMRP)
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: mawj ali Principal Investigator, College of Pharmacy, University of Bas, BPharm
- Phone Number: +9647705746266
- Email: mawjali92@gmail.com
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
The study population consists of hospitalized adult patients admitted to Al-Basrah Teaching Hospital and Al-Fayhaa General Hospital in Basra, Iraq. The cohort primarily includes individuals admitted to the Medical wards, Surgical wards, and the Neurology Intensive Care Unit (ICU).
This population represents a diverse clinical spectrum, with a particular focus on patients suffering from chronic inflammatory conditions and neurodegenerative disorders, specifically Chronic Obstructive Pulmonary Disease (COPD) and Alzheimer's Disease. The population is characterized by varying levels of nutritional risk and complex pharmacotherapy regimens (polypharmacy). Participants are recruited within the first 48 hours of admission to capture point-prevalence data. The demographic includes both males and females aged 18 years and older, representing the urban and suburban population served by the Basra Health Directorate.
Description
Inclusion Criteria:
- Age: Adult patients aged $\ge$ 18 years.Setting: Patients admitted to the Medicine, Surgery, or Neurology Intensive Care Unit (ICU) wards at Al-Basrah Teaching Hospital or Al-Fayhaa General Hospital.Duration of Stay: Patients who have been hospitalized for a minimum of 48 hours (to ensure a baseline for malnutrition screening and medication review).Clinical Conditions: Patients with various primary diagnoses, including specific subgroups with Chronic Obstructive Pulmonary Disease (COPD) and Alzheimer's Disease.Informed Consent: Patients or their legal guardians (especially for those in the ICU or with cognitive impairment) who provide written or verbal informed consent.
Exclusion Criteria:
- Maternity/Obstetrics: Pregnant or lactating women, as nutritional requirements and physiological BMI changes differ from the general adult population.
Terminal Illness: Patients in end-of-life or palliative care where nutritional intervention is no longer a clinical goal.
Incomplete Records: Patients with missing medical or medication charts that prevent the accurate identification of Medication-Related Problems (MRPs).
Short Stay: Patients planned for discharge or transfer within less than 48 hours of admission.
Psychiatric Disorders: Patients with primary psychiatric diagnoses that may interfere with the ability to conduct nutritional assessments (unless a guardian is present).
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Hospitalized Adults in Basrah
This cohort consists of 200 adult patients (age > 18 years) admitted to the Medicine, Surgery, and Neurology ICU wards of Al-Basrah Teaching Hospital and Al-Fayhaa General Hospital.
|
Intervention Description"This observational intervention consists of a multi-disciplinary clinical assessment conducted in three distinct phases for each enrolled participant:Validated Two-Step Nutritional Evaluation: Unlike standard hospital screening, this study uses the Nutritional Risk Screening (NRS-2002) as an initial filter.
Patients identified as 'at risk' (score $\ge$ 3) are immediately subjected to the Global Leadership Initiative on Malnutrition (GLIM) criteria.
This provides a definitive diagnosis by combining phenotypic criteria (non-volitional weight loss, low BMI, or reduced muscle mass) with etiologic criteria (reduced food intake/malabsorption or disease-related inflammation/chronic illness).Specialized Comorbidity Analysis: The assessment specifically targets the impact of Chronic Obstructive Pulmonary Disease (COPD) and Alzheimer's Disease on nutritional status, evaluating how respiratory hypermetabolism and cognitive impairment act as independent drivers of malnutri
Other Names:
To distinguish your research from a standard hospital audit or a basic nutritional survey, your description must highlight the systematic, two-step diagnostic workflow and the integration of clinical pharmacy oversight.Use the following detailed description for your entry:Intervention Description"This observational intervention consists of a multi-dimensional clinical assessment conducted in three specific phases for each participant:Validated Two-Step Nutritional Protocol: Unlike standard care, which may lack formal screening, this intervention applies the Nutritional Risk Screening (NRS-2002) within 48 hours of admission.
Participants identified as 'at risk' (score $\ge$ 3) are immediately subjected to the Global Leadership Initiative on Malnutrition (GLIM) criteria.
This provides a definitive diagnosis by combining phenotypic criteria (non-volitional weight loss, low BMI, or reduced muscle mass) with etiologic criteria (reduced food intake/malabsorption or disease-related inflammati
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
oint Prevalence of Malnutrition using GLIM Criteria and NRS-2002
Time Frame: Within 48 hours of hospital admission
|
The primary goal is to determine the prevalence of malnutrition among hospitalized adult patients in Al-Basrah Teaching Hospital and Al-Fayhaa General Hospital.
All participants are first screened using the Nutritional Risk Screening (NRS-2002).
For those identified as "at risk" (score $\ge$ 3), a definitive diagnosis is made using the Global Leadership Initiative on Malnutrition (GLIM) criteria.
Diagnosis requires at least one phenotypic criterion (non-volitional weight loss, low BMI, or reduced muscle mass) and one etiologic criterion (reduced food intake/malabsorption or disease-related inflammation/chronic illness, such as COPD or critical illness in the Neurology ICU).
The prevalence will be reported as the percentage of the total cohort meeting the GLIM diagnostic threshold.
|
Within 48 hours of hospital admission
|
|
Point Prevalence of Malnutrition using GLIM Criteria , NRS2002
Time Frame: Within 48 hours of hospital admission.
|
The primary goal is to determine the prevalence of malnutrition among hospitalized adult patients in Al-Basrah Teaching Hospital and Al-Fayhaa General Hospital.
All participants are first screened using the Nutritional Risk Screening (NRS-2002).
For those identified as "at risk" (score $\ge$ 3), a definitive diagnosis is made using the Global Leadership Initiative on Malnutrition (GLIM) criteria.
Diagnosis requires at least one phenotypic criterion (non-volitional weight loss, low BMI, or reduced muscle mass) and one etiologic criterion (reduced food intake/malabsorption or disease-related inflammation/chronic illness, such as COPD or critical illness in the Neurology ICU).
The prevalence will be reported as the percentage of the total cohort meeting the GLIM diagnostic threshold.
|
Within 48 hours of hospital admission.
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
Study record dates
Study Major Dates
Study Start (Estimated)
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
- Pathologic Processes
- Chronic Disease
- Disease Attributes
- Respiratory Tract Diseases
- Lung Diseases
- Lung Diseases, Obstructive
- Pathological Conditions, Signs and Symptoms
- Pulmonary Disease, Chronic Obstructive
- Organization and Administration
- Health Services Administration
- Health Care Quality, Access, and Evaluation
- Investigative Techniques
- Epidemiologic Methods
- Data Collection
- Health Care Evaluation Mechanisms
- Quality of Health Care
- Public Health
- Environment and Public Health
- Epidemiologic Measurements
- Patient Care Management
- Medication Systems
- Nutrition Assessment
- Medication Review
Other Study ID Numbers
- hospitalized malnutrition
- AMMRP-2026-BASRA (Other Identifier: University of Basrah , College of Pharmacy)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Study Data/Documents
-
Study Protocol
Information identifier: mawjali92@gmail.comInformation comments: "This research is a prospective, cross-sectional observational study conducted as part of a Master's degree in Clinical Pharmacy.
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 Alzheimer s Disease
-
University Hospital, GrenobleRecruiting
-
Fujian Medical University Union HospitalRecruitingAlzheimer s DiseaseChina
-
AkesoNot yet recruitingAlzheimer' s DiseaseChina
-
University of California, Los AngelesRecruitingAlzheimer Disease | Dementia Alzheimer Type | Alzheimer&Amp;#39;s Disease (AD) | Alzheimer&Amp;Amp;#39;s Disease | Mild Alzheimer&Amp;Amp;#39;s Disease | Moderate Alzheimer&Amp;Amp;#39;s Disease | Alzheimer&Amp;#39;s DementiaUnited States
-
Beijing Tiantan HospitalNot yet recruiting
-
Danyang Huichuang Medical Equipment Co., Ltd.RecruitingAlzheimer s DiseaseChina
-
Imperial College LondonEnrolling by invitation
-
Johns Hopkins UniversityNational Institutes of Health (NIH)Not yet recruiting
-
Xuanwu Hospital, BeijingEnrolling by invitation
-
Stanford UniversityNot yet recruitingMCI With Increased Risk for Alzheimer Disease | Alzheimer s DiseaseUnited States
Clinical Trials on Nutritional Assessment and Medication Review
-
Joke WuytsAssociation of Belgian Pharmacies (APB)Completed
-
Anne Estrup OlesenFrederikshavn Kommune, Frederikshavn, Denmark; Lægeklinikken Frederikshavn,...Completed
-
Diakonhjemmet HospitalUniversity of Oslo; Diakonhjemmet Hospital Pharmacy; Diakonhjemmet FoundationCompletedDrug-Related Side Effects and Adverse Reactions | Drug Interaction Potentiation | Medication Compliance | Remission | Medicinal Substance; Adverse EffectNorway
-
University of BernEnrolling by invitationPrimary Care | Medication ReviewSwitzerland
-
Psychiatric Research Unit, Region Zealand, DenmarkRegion Zealand; Steno Diabetes Center SjaellandCompletedPsychotic Disorders | Diabetes | Schizophrenia | Metabolic Syndrome | Bipolar Disorder | Major Depressive Disorder | Psychosis | Severe Mental DisorderDenmark
-
Geriatric Education and Research InstituteTan Tock Seng Hospital; Changi General HospitalCompletedMultimorbidity | Polypharmacy | Potentially Inappropriate MedicationsSingapore
-
Monash University MalaysiaCompleted
-
University of AarhusAarhus University HospitalCompleted