VA Nutrition Study on Immune Function

This study has been completed.
Sponsor:
Collaborator:
University of Oklahoma
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT00105625
First received: March 16, 2005
Last updated: February 6, 2014
Last verified: June 2008
  Purpose

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 problems frequently experienced in these patients. In this study, we examine the role of nutrition in inpatient geriatric rehabilitation patients' immune function and infection rates.


Condition
Malnutrition
Infection
Nosocomial Infection

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Immunocompetency and Nutritive Status in Inpatient Gero-Rehabilitation

Resource links provided by NLM:


Further study details as provided by Department of Veterans Affairs:

Estimated Enrollment: 100
Study Start Date: March 2003
Study Completion Date: September 2007
Primary Completion Date: September 2007 (Final data collection date for primary outcome measure)

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 nutritional problems frequently experienced in these patients. In this study, we examined the role of nutrition in inpatient geriatric rehabilitation patients' immune function and infection rates.

Objectives:

We examined immunologic correlates of nutritional status in elderly veterans hospitalized for extended periods of inpatient rehabilitation. We tested the hypotheses that geriatric rehabilitation inpatients who receive standard clinical and dietary care: 1) experience deficiencies in nutrients important to immune function while they are hospitalized; and 2) those patients deficient in nutrients important for immune function experience higher infection rates.

Secondary objectives included: 1) identifying nutritional and physiological factors that might lead to immune function deficiencies and infection; and 2) developing a clinical assessment model of malnutrition that can be used to assess immune function in geriatric rehabilitation inpatients.

Methods:

In this descriptive cohort study, to test Hypothesis 1, we collected data to describe, over time, in 100 non-acute elderly patients receiving longer-term inpatient rehabilitation care, trends in and relationships among: 1) caloric, protein, and immunologically-relevant micronutrient intake; 2) body composition, metabolism, and biochemical indices of nutritional status; 3) humoral and cell mediated immunity; and 4) infection. To test Hypothesis 2, we collected data to examine differences in infection rates in adequately versus inadequately nourished patients. Secondarily, our study was conducted to examine the relationship of patients' eating, their nutritional status, and their immune function over time.

Status:

Project data collection activities have been completed. A total sample size of 100 patients completed the study protocol. No study-related serious adverse events occurred during study implementation. As declared above, while data analysis activities have been initiated as planned, no study results or findings are ready to report at this time.

  Eligibility

Ages Eligible for Study:   55 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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 Criteria:

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)

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00105625

Locations
United States, Oklahoma
Oklahoma City VA Medical Center, Oklahoma City, OK
Oklahoma City, Oklahoma, United States, 73104
Sponsors and Collaborators
University of Oklahoma
Investigators
Principal Investigator: Jonelle E. Wright, PhD MSN BSN Department of Veterans Affairs
  More Information

No publications provided

Responsible Party: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT00105625     History of Changes
Other Study ID Numbers: NRI 99-340, OUHSC GCRC 0024
Study First Received: March 16, 2005
Last Updated: February 6, 2014
Health Authority: United States: Federal Government

Keywords provided by Department of Veterans Affairs:
Geriatrics
Nutrition
Immune function
Infection
Rehabilitation
Inpatient

Additional relevant MeSH terms:
Malnutrition
Nutrition Disorders
Cross Infection
Infection

ClinicalTrials.gov processed this record on August 21, 2014