Hospitalized Elderly Clinical Trial
Official title:
A Randomized Double Blinded Controlled Trial of an Oral Nutritional Supplement Containing AN 777 in Older Hospitalized Patients
| Verified date | April 2015 |
| Source | Abbott Nutrition |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | United States: Institutional Review Board |
| Study type | Interventional |
Evaluate effects of an oral nutritional supplement on healthcare outcomes in older hospitalized adults. Also referred to as the NOURISH Study - Nutrition effect On Unplanned Readmissions and Survival in Hospitalized patients.
| Status | Completed |
| Enrollment | 652 |
| Est. completion date | October 2014 |
| Est. primary completion date | October 2014 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 65 Years and older |
| Eligibility |
Inclusion Criteria: 1. Male or female = 65 years of age. 2. Admitted to hospital with diagnosis of heart failure, acute myocardial infarction, pneumonia, or chronic obstructive pulmonary disease. 3. Subjective Global Assessment rating of B or C. 4. Length of hospital stay anticipated to be > 3 days and < 12 days 5. Able to consume foods and beverages orally. 6. Functionally ambulatory during the 30 days prior to admission. Exclusion Criteria: 1. Uncontrolled hypertension 2. Diagnosis of diabetes 3. Current active cancer or recently treated cancer 4. Impaired renal function 5. Liver failure, acute Hepatitis, or hepatic encephalopathy 6. Active tuberculosis. 7. HIV 8. Disorder of gastrointestinal tract 9. Autoimmune disorder 10. Intubation, and/or tube or parenteral feeding. 11. Severe dementia or delirium, brain metastases, eating disorder, history of significant neurological or psychiatric disorder, alcoholism, substance abuse or other conditions that may interfere with study product consumption or compliance with study protocol procedures 12. Allergy or intolerance to any of the ingredients in the study products. 13. Body mass index of = 40 kg/m2. 14. Resident in a nursing home or other residential facility. 15. Planned surgery during course of the study. |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Puerto Rico | San Juan Bautista School of Medicine | Caguas | |
| Puerto Rico | Western Cardiovascular Surgery of Puerto Rico | Mayaguez | |
| Puerto Rico | Research and Cardiovascular Corp | Ponce | |
| Puerto Rico | VA Caribbean Healthcare System | San Juan | |
| United States | University of New Mexico Health Sciences Center | Albuquerque | New Mexico |
| United States | Mission Hospital | Asheville | North Carolina |
| United States | King's Daughters Medical Center, Kentucky Heart Foundation , Inc. | Ashland | Kentucky |
| United States | Emory University | Atlanta | Georgia |
| United States | Emory University Hospital | Atlanta | Georgia |
| United States | ZASA Clinical Research | Atlantis | Florida |
| United States | Auburn University | Auburn | Alabama |
| United States | Maine Research Associates | Auburn | Maine |
| United States | Aurora Denver Cardiology Associates, PC | Aurora | Colorado |
| United States | Johns Hopkins University Hospital | Baltimore | Maryland |
| United States | MedStar Health Research Institute - MedStar Union Memorial Hospital | Baltimore | Maryland |
| United States | Eastern Maine Medical Center | Bangor | Maine |
| United States | The Hope Heart Institute | Bellevue | Washington |
| United States | Birmingham Heart Clinic | Birmingham | Alabama |
| United States | Visions Clinical Research, LLC | Boynton Beach | Florida |
| United States | Pulmonary and Sleep of Tampa Bay | Brandon | Florida |
| United States | Erie County Medical Center | Buffalo | New York |
| United States | Medical University of South Carolina | Charleston | South Carolina |
| United States | PMG research of Charleston | Charleston | South Carolina |
| United States | Northwestern University | Chicago | Illinois |
| United States | University of Illinois at Chicago | Chicago | Illinois |
| United States | The Carl and Edyth Lindner Center for Research and Education at The Christ Hospital | Cincinnati | Ohio |
| United States | Morton Plant Mease HealthCare | Clearwater | Florida |
| United States | MetroHealth Medical Center | Cleveland | Ohio |
| United States | Kootenai Heart Clinics, LLC | Coeur d' Alene | Idaho |
| United States | Texas A&M University | College Station | Texas |
| United States | Palmetto Senior Primary Care Practice | Columbia | South Carolina |
| United States | Columbus Regional Research Institute | Columbus | Georgia |
| United States | Riverside Methodist Hospital | Columbus | Ohio |
| United States | Atlanta Institute for Medical Research | Decatur | Georgia |
| United States | Seidman Clinical Trials | Delray Beach | Florida |
| United States | Doylestown Hospital | Doylestown | Pennsylvania |
| United States | North Ohio Research | Elyria | Ohio |
| United States | Physician Specialists of Northern Lancaster County Medical Group | Ephrata | Pennsylvania |
| United States | Sanford Clinic North-Fargo | Fargo | North Dakota |
| United States | UConn Health Center | Farmington | Connecticut |
| United States | Hunterdon Cardiovascular Associates | Flemington | New Jersey |
| United States | McLaren-Flint Research Institute | Flint | Michigan |
| United States | UCSF Fresno | Fresno | California |
| United States | Broward Health - Broward General Medical Center | Ft. Lauderdale | Florida |
| United States | St. Jude Medical Center | Fullerton | California |
| United States | University of Florida | Gainesville | Florida |
| United States | Glendale Adventist Medical Center | Glendale | California |
| United States | East Carolina University | Greenville | North Carolina |
| United States | St John Hospital & Medical Center | Grosse Pointe Woods | Michigan |
| United States | Hackensack University Medical Center | Hackensack | New Jersey |
| United States | Research Concierge, LLC | Hartford | Kentucky |
| United States | Kentucky Lung Clinic | Hazard | Kentucky |
| United States | In Vivo Clinical Research | Hialeah | Florida |
| United States | Edward Hines VA Hospital | Hines | Illinois |
| United States | Heart Center Research, LLC | Huntsville | Alabama |
| United States | St Vincent Medical Group | Indianapolis | Indiana |
| United States | University of Iowa Hospitals and Clinics | Iowa City | Iowa |
| United States | Jacksonville Center for Clinical Research | Jacksonville | Florida |
| United States | River City Clinical Research | Jacksonville | Florida |
| United States | Bronson Healthcare Group | Kalamazoo | Michigan |
| United States | eStudySite, La Mesa | La Mesa | California |
| United States | South Orange County Surgical Medical Group | Laguna Hills | California |
| United States | The Cardiovascular Center, P.A. | Lake Mary | Florida |
| United States | Watson Clinic Center for Research, Inc. | Lakeland | Florida |
| United States | Largo Medical Center | Largo | Florida |
| United States | eStudySite, Las Vegas | Las Vegas | Nevada |
| United States | Tanner Clinic | Layton | Utah |
| United States | Baptist Health Center for Clinical Research | Little Rock | Arkansas |
| United States | Jewish Hospital & St Mary's Healthcare | Louisville | Kentucky |
| United States | Medical Center of the Rockies | Loveland, | Colorado |
| United States | Panama Clinical Research Associates | Lynn Haven | Florida |
| United States | Activmed Practices & Research, Inc | Methuen | Massachusetts |
| United States | Cuervo Clinical Research Group, Inc | Miami | Florida |
| United States | Health & Life Research Solutions Inc. | Miami | Florida |
| United States | University of Miami Miller School of Medicine | Miami | Florida |
| United States | Novo Research dba FCPP Research | Modesto | California |
| United States | HealthScan Research | Montgomery | Alabama |
| United States | Virtua Medical Group | Moorestown | New Jersey |
| United States | STHS Heart, LLC | Nashville | Tennessee |
| United States | Vanderbilt University Medical Center | Nashville | Tennessee |
| United States | Ochsner Medical Center | New Orleans | Louisiana |
| United States | Columbia University Medical Center | New York | New York |
| United States | Sentara Cardiovascular Research Institute | Norfolk | Virginia |
| United States | Ocala Research Institute, Inc. | Ocala | Florida |
| United States | eStudySite, Oceanside | Oceanside | California |
| United States | Alegent Creighton Health Heart & Vascular Specialists | Omaha | Nebraska |
| United States | Creighton University | Omaha | Nebraska |
| United States | Pulmonary Consultant & Primary Physicians Medical Group | Orange | California |
| United States | Cardiovascular Institute of Northwest Florida | Panama City | Florida |
| United States | Cardiology Consultants | Pensacola | Florida |
| United States | Drexel University College of Medicine | Philadelphia | Pennsylvania |
| United States | Advanced Clinical Research Associates | Plano | Texas |
| United States | David M Headley | Port Gibson | Mississippi |
| United States | VA Sierra Nevada Health Care System | Reno | Nevada |
| United States | Carilion Medical Center Geriatrics | Roanoke | Virginia |
| United States | Rochester General Hospital | Rochester | New York |
| United States | Crittenton Hospital Medical Center | Rochester Hills | Michigan |
| United States | William Beaumont Hospital | Royal Oak | Michigan |
| United States | Salem VA Medical Center | Salem | Virginia |
| United States | Sonterra Clinical Research | San Antonio | Texas |
| United States | Sonterra Clinical Research | San Antonio | Texas |
| United States | South Texas Cardiovascular Consultants | San Antonio | Texas |
| United States | Donald Guthrie Foundation for Education and Research, Inc. | Sayre | Pennsylvania |
| United States | Scottsdale Healthcare | Scottsdale | Arizona |
| United States | Grand View Hospital Clinical Research | Sellersville | Pennsylvania |
| United States | Louisiana State University Health Science Center | Shreveport | Louisiana |
| United States | Sanford Clinic Family Medicine | Sioux Falls | South Dakota |
| United States | Regenerate Clinical Trials | South Miami | Florida |
| United States | Baystate Medical Center | Springfield | Massachusetts |
| United States | St Anthony's Medical Center | St. Louis | Missouri |
| United States | HealthEast St Joseph's Hospital | St. Paul | Minnesota |
| United States | Advanced Clinical Research Group | Stuart | Florida |
| United States | Los Angeles Biomedical Research Institution | Torrance | California |
| United States | Associated Cardiovascular Consultants of Lourdes | Voorhees | New Jersey |
| United States | Cardiology Partners Clinical Research Institute | Wellington | Florida |
| United States | The Reading Hospital and Medical Center | West Reading | Pennsylvania |
| United States | Wake Forest University Health Sciences | Winston Salem | North Carolina |
| United States | Novant Clinical Research Institute | Winston-Salem | North Carolina |
| United States | Pinnacle Health Cardiovascular Institute, Inc. | Wormleysburg | Pennsylvania |
| Lead Sponsor | Collaborator |
|---|---|
| Abbott Nutrition |
United States, Puerto Rico,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Return to hospital or death | 90 days | No | |
| Secondary | Return to hospital or death | 30 and 60 days | No | |
| Secondary | Hospital Days | 90 days | No | |
| Secondary | Activities of Daily Living | Katz Activities of Daily Living at entry and 90 days | 90 days | No |