American Journal of Clinical Nutrition, Vol 47, 357-365, Copyright © 1988 by The American Society for Clinical Nutrition, Inc

REVIEW ARTICLES

A randomized clinical trial of total parenteral nutrition in malnourished surgical patients: the rationale and impact of previous clinical trials and pilot study on protocol design

GP Buzby, WO Williford, OL Peterson, LO Crosby, CP Page, GF Reinhardt and JL Mullen
VA Medical Centers, Philadelphia, PA.

The rationale for a large-scale clinical trial of preoperative total parenteral nutrition (TPN) is described in the context of previous clinical trials that have attempted to demonstrate reduction of operative morbidity with preoperative TPN. Defects in study design or execution potentially compromising the validity of these studies are analyzed. Results of a single-institution pilot study performed during the planning phase of the multiinstitutional preoperative TPN trial are presented. This literature review and pilot study provided the data necessary to permit appropriate design of many critical elements in the protocol for the clinical trial including sample size, eligibility criteria, duration and intensity of treatment regimens, and end-point criteria. The rationale underlying critical decisions in protocol design are presented in detail to allow more meaningful interpretation of the results of the clinical trial.

This article has been cited by other articles:

				K. Yamada, R. Furuya, T. Takita, Y. Maruyama, Y. Yamaguchi, S. Ohkawa, and H. Kumagai Simplified nutritional screening tools for patients on maintenance hemodialysis Am. J. Clinical Nutrition, January 1, 2008; 87(1): 106 - 113. [Abstract] [Full Text] [PDF]

				D. J Secker and K. N Jeejeebhoy Subjective Global Nutritional Assessment for children Am. J. Clinical Nutrition, April 1, 2007; 85(4): 1083 - 1089. [Abstract] [Full Text] [PDF]

				O. Bouillanne, G. Morineau, C. Dupont, I. Coulombel, J.-P. Vincent, I. Nicolis, S. Benazeth, L. Cynober, and C. Aussel Geriatric Nutritional Risk Index: a new index for evaluating at-risk elderly medical patients Am. J. Clinical Nutrition, October 1, 2005; 82(4): 777 - 783. [Abstract] [Full Text] [PDF]

				C. W. Compher, C. Spencer, and B. P. Kinosian Perioperative Parenteral Nutrition: Impact on Morbidity and Mortality in Surgical Patients Nutr Clin Pract, August 1, 2005; 20(4): 460 - 467. [Full Text] [PDF]

				Y.-C. Huang, S.-L. Wueng, C.-C. Ou, C.-H. Cheng, and K.-H. Su Nutritional Status of Functionally Dependent and Nonfunctionally Dependent Elderly in Taiwan J. Am. Coll. Nutr., April 1, 2001; 20(2): 135 - 142. [Abstract] [Full Text] [PDF]

				J. Gibbs, W. Cull, W. Henderson, J. Daley, K. Hur, and S. F. Khuri Preoperative Serum Albumin Level as a Predictor of Operative Mortality and Morbidity: Results From the National VA Surgical Risk Study Arch Surg, January 1, 1999; 134(1): 36 - 42. [Abstract] [Full Text] [PDF]

				G Zoli, G R Corazza, S Wood, R Bartoli, G Gasbarrini, and M J G Farthing Impaired splenic function and tuftsin deficiency in patients with intestinal failure on long term intravenous nutrition Gut, December 1, 1998; 43(6): 759 - 762. [Abstract] [Full Text] [PDF]