Nutritional Therapy for Stroke Patients

This study has been completed.
Sponsor:
Collaborator:
University of Oslo
Information provided by:
Ostfold Hospital Trust
ClinicalTrials.gov Identifier:
NCT00163007
First received: September 9, 2005
Last updated: May 8, 2009
Last verified: May 2009

September 9, 2005
May 8, 2009
May 2005
March 2008   (final data collection date for primary outcome measure)
Percentage of patients with weight loss >=5 % at three month follow-up.
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Complete list of historical versions of study NCT00163007 on ClinicalTrials.gov Archive Site
Quality of life, handgrip strength and nutritional status at three months. Dietary intake in hospital. Length of hospital stay.
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Nutritional Therapy for Stroke Patients
Nutritional Therapy for Patients With Acute Stroke and With Poor Nutritional Status or at Risk of Poor Nutritional Status

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.

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.

Interventional
Phase 2
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Stroke
  • Malnutrition
  • Weight Loss
  • Dysphagia
Procedure: Nutritional support
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
125
June 2008
March 2008   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Norway
 
NCT00163007
297
Not Provided
Not Provided
Ostfold Hospital Trust
University of Oslo
Study Chair: Truls Hauge, PhD Ullevaal University Hospital
Ostfold Hospital Trust
May 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP