Nutritional Therapy for Stroke Patients

Ostfold Hospital Trust

Status and phase: Completed; Phase 3; Phase 2

Conditions: Weight Loss; Dysphagia; Malnutrition; Stroke

Treatments: Procedure: Nutritional support

Study type: Interventional

Funder types: Other

Identifiers

NCT00163007

297

Details and patient eligibility

About

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.

Full 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 e.g. mortality and comorbidity. Secondary outcome measures were then defined as handgrip strength, quality of life, nutritional status, nutrient intake and length of hospital stay.

Enrollment: 125 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Acute stroke based on clinical symptoms
• 18 years old and above
• < 7 days since debut of stroke symptoms and either body mass index (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 and planned operation
• Severe dementia
• Reduced consciousness
• Immobility
• Expected short-time survival

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)