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. Main end-points are nutritional status, functional status and mortality.

Condition	Intervention	Phase
Stroke Malnutrition Weight Loss Dysphagia	Procedure: Nutritional support	Phase II Phase III

Further Study Details: 

Expected Total Enrollment:  200

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. Main end-points are nutritional status, functional status and mortality.

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

Criteria

Inclusion Criteria:

• Acute stroke based on clinical symptoms
• 18 years old and above
• <6 days since debut of stroke symptoms and either BMI=or<20
• Weight loss >5% in 3-6 months or there has been little or is likely to be no or very little nutritional intake for >5 days

Exclusion Criteria:

• Subarachnoidal bleeding
• Severe dementia
• Reduced consciousness
• Immobility
• Expected short-time survival

Please refer to this study by ClinicalTrials.gov identifier  NCT00163007

Lisa Ha, MSc      +47 69 86 00 96    Lisa.Ha@so-hf.no
Truls Hauge, MD, Ph D       trulhaug@online.no

Norway
      Ostfold Hospital Trust Moss, Moss,  1535,  Norway; Recruiting

Study chairs or principal investigators

Truls Hauge, Ph D,  Study Chair,  Ullevaal University Hospital   

Study ID Numbers:  297
Last Updated:  September 12, 2005
Record first received:  September 9, 2005
ClinicalTrials.gov Identifier:  NCT00163007
Health Authority: Norway: The National Committees for Research Ethics in Norway
ClinicalTrials.gov processed this record on 2005-09-13