Nutritional Therapy for Stroke Patients

Stroke Clinical Trial

Official title:

Nutritional Therapy for Patients With Acute Stroke and With Poor Nutritional Status or at Risk of Poor Nutritional Status

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00163007
• Other study ID #: 297
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: September 9, 2005
• Last updated: May 8, 2009
• Start date: May 2005
• Est. completion date: June 2008

Study information

• Verified date: May 2009
• Source: Ostfold Hospital Trust
• Contact: n/a
• Is FDA regulated: No
• Health authority: Norway:National Committee for Medical and Health Research Ethics
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 125
• Est. completion date: June 2008
• Est. primary completion date: March 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Dysphagia
• Malnutrition
• Stroke
• Weight Loss

Intervention

Procedure:
• Nutritional support

Locations

Country	Name	City	State
Norway	Ostfold Hospital Trust	Fredrikstad

Sponsors (2)

Lead Sponsor	Collaborator
Ostfold Hospital Trust	University of Oslo

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of patients with weight loss >=5 % at three month follow-up.
Secondary	Quality of life, handgrip strength and nutritional status at three months. Dietary intake in hospital. Length of hospital stay.