Status:
COMPLETED
VA Nutrition Study on Immune Function
Lead Sponsor:
US Department of Veterans Affairs
Collaborating Sponsors:
University of Oklahoma
Conditions:
Malnutrition
Infection
Eligibility:
All Genders
55+ years
Brief Summary
Hospital-acquired infections can occur five times as frequently in rehabilitation patients than in other hospital admissions. We postulate that this high infection rate may be due to nutritional probl...
Detailed Description
Background: Hospital-acquired infections can occur five times as frequently in rehabilitation patients than in other hospital admissions. We postulated that this high infection rate may be due to nut...
Eligibility Criteria
Inclusion
- Patients must be in inpatient rehabilitation, be \> 55 years old, and must not suffer any of the following: on active antibiotics; chart documented malignancy, immunodeficiency (HIV, steroid treatment, plasma cell dyscrasia), advanced CHF or malabsorption syndromes (inflammatory bowel diseases such as colitis or Crohn's disease, celiac sprue, gastrectomy, bowel resection, irritable bowel syndrome, complicated diverticulitis, internal fistulae) affecting nutritional status; anemia (Hct\<25%), renal failure (serum creatinine \> 3.0 mg/dl), liver failure (alk phosp \>3x norm or bilirubin \>10mg/100ml); estimated LOS \<3 months; unable to comply with study procedures.
Exclusion
- known pre-existing infection requiring antibiotic treatment (e.g. TB, osteomyelitis, SBE) chart documented malignancy, immunodeficiency (e.g. HIV infection, steroid treatment, plasma cell dyscrasia), advanced CHF or malabsorption syndromes (inflammatory bowel diseases such as colitis or Crohn's disease, celiac sprue, gastrectomy, bowel (ileal) resection, irritable bowel syndrome, complicated diverticulitis, or internal fistulae) directly affecting nutritional status documented anemia (Hct \<25%), renal (serum creatinine \>3.0 mg/dl), or liver failure (SGPT or alkaline phosphatase \>3 times normal or bilirubin \>10mg/100mL).
- estimated admission \<3 months or noncompliance with study procedures (unable/unwilling to perform study procedures)
Key Trial Info
Start Date :
March 1 2003
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
September 1 2007
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT00105625
Start Date
March 1 2003
End Date
September 1 2007
Last Update
April 7 2015
Active Locations (1)
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1
Oklahoma City VA Medical Center, Oklahoma City, OK
Oklahoma City, Oklahoma, United States, 73104