COMPARISON OF ELIGIBLE RANDOMIZED PATIENTS WITH 2 GROUPS OF INELIGIBLE PATIENTS - CAN THE RESULTS OF THE VA TOTAL PARENTERAL-NUTRITION CLINICAL-TRIAL BE GENERALIZED

The recently reported VA Cooperative Study ''A Randomized Clinical Tri al of Total Parenteral Nutrition (TPN) in Malnourished Surgical Patien ts'' randomized 395 pre-operative patients to TPN treatment or control . The study concluded that the use of perioperative TPN should be limi ted to the most severely malnourished patients. The study also followe d 233 patients eligible for the study who refused to give informed con sent for randomization (Eligible Refusers) as well as 1220 patients wh o were ineligible because they were not sufficiently malnourished (Ind ex Group). Patients in the Index Group were determined to be significa ntly healthier than those in the two eligible groups of patients. Thos e in the Eligible Refuser group were shown to be slightly less malnour ished than the Randomized Patients. The 395 patients randomized to the study (Randomized Patients) showed the highest rate of septic complic ations at 30 days and at 90 days (10% and 13% respectively) with rates for the Eligible Refusers slightly lower (8% and 9%) and Index Group rates still lower (4% and 4%). Nonseptic complication rates showed the same pattern (19% and 22% for the Randomized group, 12% and 12% for E ligible Refusers, and 10% and 10% for the Index Group). Because (a) th e beneficial effect of TPN is attained only in severely malnourished p atients, (b) there is increased risk of septic complications with TPN use in patients not severely malnourished, (c) Index Group patients, a nd presumably the population of patients from which they are drawn, ar e not severely malnourished, it follows that unless specifically indic ated, TPN should not be used in nonseverely malnourished patients.