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
  Purpose

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.


Condition Intervention Phase
Stroke
Malnutrition
Weight Loss
Dysphagia
Procedure: Nutritional support
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Nutritional Therapy for Patients With Acute Stroke and With Poor Nutritional Status or at Risk of Poor Nutritional Status

Resource links provided by NLM:


Further study details as provided by Ostfold Hospital Trust:

Primary Outcome Measures:
  • Percentage of patients with weight loss >=5 % at three month follow-up.

Secondary Outcome Measures:
  • Quality of life, handgrip strength and nutritional status at three months. Dietary intake in hospital. Length of hospital stay.

Estimated Enrollment: 125
Study Start Date: May 2005
Study Completion Date: June 2008
Primary Completion Date: March 2008 (Final data collection date for primary outcome measure)
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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00163007

Locations
Norway
Ostfold Hospital Trust
Fredrikstad, Norway, 1603
Sponsors and Collaborators
Ostfold Hospital Trust
University of Oslo
Investigators
Study Chair: Truls Hauge, PhD Ullevaal University Hospital
  More Information

No publications provided by Ostfold Hospital Trust

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00163007     History of Changes
Other Study ID Numbers: 297
Study First Received: September 9, 2005
Last Updated: May 8, 2009
Health Authority: Norway:National Committee for Medical and Health Research Ethics

Additional relevant MeSH terms:
Deglutition Disorders
Stroke
Cerebral Infarction
Weight Loss
Malnutrition
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Pharyngeal Diseases
Otorhinolaryngologic Diseases
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Brain Infarction
Brain Ischemia
Body Weight Changes
Body Weight
Signs and Symptoms
Nutrition Disorders

ClinicalTrials.gov processed this record on April 21, 2014