(Taken from application) A surprisingly high proportion of hospitalized patients has one or more nutritional deficits. These deficiencies are usually not apparent on physical examination, and adverse clinical consequences occur after remarkably short periods of nutritional deprivation. Total parenteral nutrition (TPN) provides life-sustaining therapy for patients who are unresponsive to conventional dietary therapy, and for patients in whom malnutrition is anticipated because oral intake will be inadequate or contraindicated for periods greater than 7 to 10 days. TPN has been advocated as therapy for patients with conditions such as short bowel syndrome, inflammatory bowel disease, gastrointestinal fistula, burns, renal failure, cancer, pancreatitis, and for malnourished patients in the perioperative period. TPN is typically delivered through flexible catheters inserted under the clavicle or into the internal jugular vein and threaded into the superior vena cave, allowing for access to large caliber vessels with rapid blood flow. One type of catheter that has occasionally been used for TPN delivery is the peripherally-inserted central venous catheter (PICC). These small, soft, silicone elastomer tubes are inserted into the basilic or cephalic vein of the arm and threaded into the central vasculature. This approach has been advocated in the pediatric population because the risk of pneumothorax is virtually nonexistent and greater mobility is allowed. In addition, physician extenders and well-trained nurses can insert the PICC catheter, introducing a potential cost savings to health care institutions. This proposal will pursue the hypothesis that PICCs are safer and less expensive than the standard subclavian approach for administration of hospital-based total parenteral nutrition. We propose the first randomized clinical trial comparing the PICC line to the standard subclavian approach for hospitalized adult patients receiving TPN. Catheter related complications will be recorded. Catheter survival duration will be calculated and described in terms of incidence density ratio. Since health care charges for nutritional delivery were more than $3 billion last year in the U.S., a cost analysis of insertion and maintenance of each of the two catheters also will be performed. There is potential for significant impact on cost if PICC lines are found to be safer or comparable, since the catheters can be readily placed by a physician extender or well-trained nurse. This study will serve as a basis for developing larger cooperative clinical trial groups to further investigate issues in nutritional delivery to hospitalized patients.

Agency
National Institute of Health (NIH)
Institute
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Type
Small Research Grants (R03)
Project #
1R03DK053263-01
Application #
2446894
Study Section
Special Emphasis Panel (SRC)
Program Officer
Robuck, Patricia R
Project Start
1998-02-25
Project End
2000-01-31
Budget Start
1998-02-25
Budget End
1999-01-31
Support Year
1
Fiscal Year
1998
Total Cost
Indirect Cost
Name
University of Iowa
Department
Internal Medicine/Medicine
Type
Schools of Medicine
DUNS #
041294109
City
Iowa City
State
IA
Country
United States
Zip Code
52242