Ignite Creation Date:
2024-05-05 @ 11:53 AM
Last Modification Date:
2024-10-26 @ 9:15 AM
Study NCT ID:
NCT00163007
Status:
COMPLETED
Last Update Posted:
2009-05-11
First Post:
2005-09-09
Brief Title:
Nutritional Therapy for Stroke Patients
Sponsor:
Ostfold Hospital Trust
Organization:
Ostfold Hospital Trust
Study Overview
Official Title:
Nutritional Therapy for Patients With Acute Stroke and With Poor Nutritional Status or at Risk of Poor Nutritional Status
Status:
COMPLETED
Status Verified Date:
2009-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Prospective short-term studies in patients admitted for acute stroke have shown an increased risk of infections bedsores impaired functional outcome slower rate of recovery poorer rehabilitation potential and higher mortality in patients with a poor nutritional status In hospitals without routine nutritional assessment and individual nutrition management plans the risk of patients developing malnutrition may be increased In this study patients admitted for acute stroke are randomised into either receiving nutritional therapy derived from estimated individual nutritional intake and nutritional needs or nutritional therapy based on routine care without routine assessment of nutritional status intake or needs The primary outcome measure is the percentage of patients with weight loss 5 at three month follow-up
Detailed Description:
Prospective short-term studies in patients admitted for acute stroke have shown an increased risk of infections bedsores impaired functional outcome slower rate of recovery poorer rehabilitation potential and higher mortality in patients with a poor nutritional status Sixteen percent of stroke patients are already malnourished on admission to hospital The incidence of dysphagia in patients with acute stroke ranges from 30 to 45 Dysphagia increases the risk of developing poor nutritional status and new cases of malnutrition develop during the hospital stay even during the first week In hospitals without routine nutritional assessment and individual nutrition management plans the risk of patients developing malnutrition may be increased In this study patients admitted for acute stroke are randomised into either receiving nutritional therapy derived from estimated individual nutritional intake and nutritional needs or nutritional therapy based on routine care without routine assessment of nutritional status intake or needs Nutritional therapy enriched meals sip-feedings or enteral feedings Parameters of nutritional status Weight BMI TSF thickness mid upper arm circumference body composition s-albumin and s-transferrin Estimation of nutritional intake Daily registration of food and drink intake Estimating functional status Hand grip strength Barthels ADL index and Scandinavian stroke scale Estimating quality of life EQ-5D
Before the inclusion started we decided to use the percentage of patients with weight loss 5 at 3 months follow-up as the primary outcome measure because this is correlated better to clinical outcomes as eg mortality and comorbidity Secondary outcome measures were then defined as handgrip strength quality of life nutritional status nutrient intake and length of hospital stay
Before the inclusion started we decided to use the percentage of patients with weight loss 5 at 3 months follow-up as the primary outcome measure because this is correlated better to clinical outcomes as eg mortality and comorbidity Secondary outcome measures were then defined as handgrip strength quality of life nutritional status nutrient intake and length of hospital stay
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None