Malnutrition Clinical Trial
Official title:
Prevalence and Impact of Hospital Malnutrition on Associated Outcomes
| NCT number | NCT02508974 |
| Other study ID # | N14/06/061 |
| Secondary ID | |
| Status | Completed |
| Phase | |
| First received | |
| Last updated | |
| Start date | January 2015 |
| Est. completion date | December 2017 |
| Verified date | May 2018 |
| Source | University of Stellenbosch |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
Malnutrition of patients on admission to hospitals are estimated to be as high as 60%, although the prevalence varies between countries. The impact of malnutrition on patient recovery and discharge is severe, with extensive cost implications. This study aims to assess the prevalence of at risk for malnutrition among adult patients admitted to hospital across 3 countries on the African continent.
| Status | Completed |
| Enrollment | 2126 |
| Est. completion date | December 2017 |
| Est. primary completion date | December 2017 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility |
Inclusion Criteria: - All patients older than 18 years of age - Males and females - Admitted to hospital within the past 48 hours - Conscious - Informed consent provided Exclusion Criteria: - Paediatric patients younger than 18 years - Pregnant and lactating females - Patients admitted to ICU, burns or relevant acute care wards - Patients admitted to psychiatry or eating disorders units - Patients on dialysis |
| Country | Name | City | State |
|---|---|---|---|
| South Africa | Tygerberg Hospital | Cape Town | Western Cape |
| Lead Sponsor | Collaborator |
|---|---|
| University of Stellenbosch |
South Africa,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Change in prevalence of risk for malnutrition during the period of hospitalization | Baseline (Admission) data will be gathered during to the first 48 hours after hospital admission. Discharge data (Day 28) is collected on day of actual discharge or on day 28 of hospitalization if patient is staying in hospital longer than that. A NRS-2002 score greater than 3 indicates risk for malnutrition. | Baseline; day 28 | |
| Secondary | Association between risk for malnutrition and in-hospital and post-discharge nutritional / medical indicators | Baseline (Admission) data will be gathered during to the first 48 hours after hospital admission. Discharge data (Day 28) is collected on day of actual discharge or on day 28 of hospitalization if patient is staying in hospital longer than that. Post discharge data will be gathered 3 months after hospital discharge i.e. day 90 (again within a 48 hour period). Nutritional indications refer to weight changes (gain or loss) and changes in appetite (improved, no change or decreased). Medical indicators refer to nr of new complications requiring medical treatment, mortality or re-hospital admission.A NRS-2002 score greater than 3 indicates risk for malnutrition. | Baseline; day 28 and Day 90 | |
| Secondary | Number of patients obtaining similar screening scores as a measure of relative validity of the different screening tools used against each other | Baseline (Admission) data will be gathered during to the first 48 hours after hospital admission. Discharge data (Day 28) is collected on day of actual discharge or on day 28 of hospitalization if patient is staying in hospital longer than that. A good validity will be indicated by a sensitivity and specificity of more than 80%. | Baseline and day 28 |
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