Clinical trial NCT00163007: Nutritional Therapy for Stroke Patients
Official title: Nutritional Therapy for Patients With Acute Stroke and With Poor Nutritional Status or at Risk of Poor Nutritional Status
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Stroke
Malnutrition
Weight Loss
Dysphagia
Lead sponsor: Ostfold Hospital Trust
Sponsor class: OTHER
Collaborators: name: University of Oslo
First posted: 2005-09-13
Enrollment: 125
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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.

Eligibility criteria: 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

Primary outcomes:
measure: Percentage of patients with weight loss >=5 % at three month follow-up.
Secondary outcomes:
measure: Quality of life, handgrip strength and nutritional status at three months. Dietary intake in hospital. Length of hospital stay.
Other outcomes:
Locations:
city: Fredrikstad
country: Norway
facility: Ostfold Hospital Trust
Study officials:
affiliation: Ullevaal University Hospital
name: Truls Hauge, PhD
role: STUDY_CHAIR
References:
citation: Ha L, Hauge T, Iversen PO. Body composition in older acute stroke patients after treatment with individualized, nutritional supplementation while in hospital. BMC Geriatr. 2010 Oct 18;10:75. doi: 10.1186/1471-2318-10-75.
citation: Ha L, Hauge T, Spenning AB, Iversen PO. Individual, nutritional support prevents undernutrition, increases muscle strength and improves QoL among elderly at nutritional risk hospitalized for acute stroke: a randomized, controlled trial. Clin Nutr. 2010 Oct;29(5):567-73. doi: 10.1016/j.clnu.2010.01.011. Epub 2010 Feb 21.