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Nutrition Society Symposium on ‘End points in clinical nutrition trials’ Death, morbidity and economics are the only end points for trials

Published online by Cambridge University Press:  07 March 2007

Ronald L. Koretz
Ronald L. Koretz
Affiliation:
Division of Gastroenterology, Olive View-UCLA Medical Center, 14445 Olive View Drive, Sylmar, California, 91342, USA and UCLA School of Medicine, Los Angeles, California, USA
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Abstract

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In order to determine whether surrogate markers predict clinical outcome, randomized controlled trials (RCT) of nutrition support v. no nutrition support that have reported at least one clinical outcome (mortality, infections, total complications, or duration of hospitalization) and at least one nutritional outcome (energy or protein intake, weight gain, N balance, albumin, prealbumin, transferrin, three anthropometric measures, skin testing, lymphocyte count) were assessed for concordance. If changes in nutritional markers predict clinical outcome, changes in both outcomes should go in the same direction. Concordance is defined as both outcomes changing in the same direction or both outcomes showing no difference. Discordance is defined as one outcome changing and the other not (partial) or both outcomes changing in opposite directions (complete). Ninety-nine RCT were identified, of which most were underpowered to see statistically significant changes, especially in clinical outcomes. Thus, the results were analysed only in relation to the direction of the respective changes in outcomes. Forty-eight comparisons (4×12) were made. The rates of concordance were ≤50% in forty-one of forty-eight comparisons; the rate was never >75%. A complete discordance rate of ≥25% was present in forty-three (≥50% in thirteen) of the forty-eight comparisons. The discordance was usually a result of the nutritional outcome being better than the clinical outcome. Changes in nutritional markers do not predict clinical outcomes. Before adopting any surrogate marker as an end point for a clinical trial, it has to be known that improving it will result in patient benefit.

Keywords

Nutrition supportOutcomesSurrogate outcomesIntermediate outcomesEnd points
Type
Meeting Report
Information
Proceedings of the Nutrition Society , Volume 64 , Issue 3 , August 2005 , pp. 277 - 284
Copyright
Copyright © The Nutrition Society 2005

References

Baker, JP, Detsky, AS, Wesson, DE, Wolman, SL, Stewart, S, Whitewall, J, Langer, B & Jeejeebhoy, KN (1982) Nutritional assessment. A comparison of clinical judgment and objective measurements. New England Journal of Medicine 306, 969–972.CrossRefGoogle Scholar
Buzby, GP, Mullen, JL, Matthews, DC, Hobbs, CL & Dosato, EF (1980) Prognostic nutritional index in gastrointestinal surgery. American Journal of Surgery 139, 160–167.CrossRefGoogle ScholarPubMed
Cochrane, Injuries, Group, Albumin Reviewers (1998) Human albumin administration in critically ill patients: systematic review of randomised controlled trials. British Medical Journal 317, 235–240.Google Scholar
Dudrick, SJ & Ruberg, RL (1971) Principles and practice of parenteral nutrition. Gastroenterology 61, 901–910.CrossRefGoogle ScholarPubMed
Dudrick, SJ, Wilmore, DW, Vars, HM & Rhoads, JE (1968) Long-term parenteral nutrition with growth, development, and positive nitrogen balance. Surgery 64, 134–142.Google ScholarPubMed
Fletcher, JP & Little, JM (1986) A comparison of parenteral nutrition and early postoperative enteral feeding on the nitrogen balance after major surgery. Surgery 100, 21–24.Google ScholarPubMed
HIV Surrogate Marker Collaborative Group (2000) Human immunodeficiency virus Type 1RNA level and CD4 count as prognostic markers and surrogate end points: a meta-analysis. AIDS Research and Human Retrovirus 16, 1123–1133.CrossRefGoogle Scholar
Keys, A (1962) Caloric deficiency and starvation Clinical Nutrition, 2nd ed. 122–136 [Jolliffe, N, editor]. New York: Harper and Brothers.Google Scholar
Koretz, RL (1995) Intravenous albumin and nutrition support: going for the quick fix. Journal of Parenteral and Enteral Nutrition 19, 166–171.CrossRefGoogle ScholarPubMed
Koretz, RL, Lipman, TO & Klein, S (2001) AGA technical review – Parenteral nutrition. Gastroenterology 121, 970–1001.CrossRefGoogle ScholarPubMed
Reinhardt, GF, Myscofski, JW, Wilkens, DB, Dobrin, PB, Mangan JE, Jr, Stannard, RT (1980) Incidence and mortality of hypoalbuminemic patients in hospitalized veterans. Journal of Parenteral and Enteral Nutrition 4, 357–359.CrossRefGoogle ScholarPubMed
Rhoads, JE, Vars, HM & Dudrick, SJ (1981) The development of intravenous hyperalimentation. Surgical Clinics of North America 61, 429–435.CrossRefGoogle ScholarPubMed
Studley, HO (1936) Percentage of weight loss. A basic indicator of surgical risk in patients with chronic peptic ulcer. Journal of the American Medical Association 106, 458–460.CrossRefGoogle Scholar
Wilkes, MM & Navickis, PJ (2001) Patient survival after human albumin administration. Annals of Internal Medicine 135, 149–164.CrossRefGoogle ScholarPubMed
Bastow, MD, Rawlings, J & Allison, SP (1983) Benefits of supplementary tube feeding after fractured neck of femur: a randomised controlled trial. British Medical Journal 287, 1589–1592.CrossRefGoogle ScholarPubMed
Beier-Holgersen, R & Boesby, S (1996) Influence of postoperative enteral nutrition on postsurgical infections. Gut 39, 833–835.CrossRefGoogle ScholarPubMed
Cabre, E, Gonzalez-Huix, F, Abad-Lacruz, A, Esteve, M, Acero, D, Fernandez-Banares, F, Xiol, X & Gassull, MA (1990) Effect of total enteral nutrition on the short-term outcome of severely malnourished cirrhotics. Gastroenterology 98, 715–720.CrossRefGoogle ScholarPubMed
Calvey, H, Davis, M & Williams, R (1985) Controlled trial of nutritional supplementation, with and without branched chain amino acid enrichment, in treatment of acute alcoholic hepatitis. Journal of Hepatology 1, 141–151.CrossRefGoogle ScholarPubMed
Carr, CS, Ling, KDE, Boulos, P & Singer, M (1996) Randomised trial of safety and efficacy of immediate postoperative enteral feeding in patients undergoing gastrointestinal resection. British Medical Journal 312, 869–871.CrossRefGoogle ScholarPubMed
Daniels, L, Davidson, GP, Martin, AJ & Pouras, T (1989) Supplemental nasogastric feeding in cystic fibrosis patients during treatment for acute exacerbation of chest disease. Australian Paediatric Journal 25, 164–167.Google ScholarPubMed
De Ledinghen, V, Beau, P, Mannant, P-R, Borderie, C, Ripault, M-P, Silvain, C & Beauchant, M (1997) Early feeding or enteral nutrition in patients with cirrhosis after bleeding from esophageal varices? A randomized controlled study. Digestive Diseases and Sciences 42, 536–541.Google ScholarPubMed
Fletcher, JP & Little, JM (1986) A comparison of parenteral nutrition and early postoperative enteral feeding on the nitrogen balance after major surgery. Surgery 100, 21–24.Google ScholarPubMed
Hartgrink, HH, Wille, J, Konig, P, Hermans, J & Breslau, PJ (1998) Pressure sores and tube feeding in patients with a fracture of the hip: a randomized clinical trial. Clinical Nutrition 17, 287–292.CrossRefGoogle ScholarPubMed
Hasse, JM, Blue, LS, Liepa, GU, Goldstein, RM, Jennings, LW, Mor, E, Husberg, BS, Levy, MF, Gonwa, TA & Klintmalm, GB (1995) Early enteral nutrition support in patients undergoing liver transplantation. Journal of Parenteral and Enteral Nutrition 19, 437–443.CrossRefGoogle ScholarPubMed
Heslin, MJ, Latkany, L, Leung, D, Brooks, AD, Hochwald, SN, Pisters, PWT, Shike, M & Brennan, MF (1997) A prospective, randomized trial of early enteral feeding after resection of upper gastrointestinal malignancy. Annals of Surgery 226, 567–580.CrossRefGoogle ScholarPubMed
Kearns, PJ, Young, H, Garcia, G, Blaschke, T, O'Hanlon, G, Rinki, M, Sucher, K & Gregory, P (1992) Accelerated improvement of alcoholic liver disease with enteral nutrition. Gastroenterology 102, 200–205.CrossRefGoogle ScholarPubMed
Moore, EE & Jones, TN (1986) Benefits of immediate jejunostomy feeding after major abdominal trauma – a prospective, randomized study. Journal of Trauma 26, 874–881.CrossRefGoogle ScholarPubMed
Sagar, S, Harland, P & Shields, R (1979) Early postoperative feeding with elemental diet. British Medical Journal i, 293–295.CrossRefGoogle Scholar
Shukla, HS, Rao, RR, Banu, N, Gupta, RM & Yadav, RC (1984) Enteral hyperalimentation in malnourished surgical patients. Indian Journal of Medical Research 80, 339–346.Google ScholarPubMed
Singh, G, Ram, RP & Khanna, SK (1998) Early postoperative enteral feeding in patients with nontraumatic intestinal perforation and peritonitis. Journal of the American College of Surgery 187, 142–146.CrossRefGoogle ScholarPubMed
Smith, RC, Hartemink, RJ, Hollinshead, JW & Gillett, DJ (1985) Fine bore jejunostomy feeding following major abdominal surgery: a controlled randomized clinical trial. British Journal of Surgery 72, 458–461.CrossRefGoogle ScholarPubMed
Spirtos, NM & Ballon, SC (1988) Needle catheter jejunostomy: a controlled, prospective, randomized trial in patients with gynecologic malignancy. American Journal of Obstetrics and Gynecology 158, 1285–1290.CrossRefGoogle ScholarPubMed
Sullivan, DH, Nelson, CL, Bopp, MM, Puskarich-May, CL & Walls, RC (1998) Nightly enteral nutrition support of elderly hip fracture patients: a phase I trial. Journal of the American College of Nutrition 17, 155–161.CrossRefGoogle ScholarPubMed
Tandon, SP, Gupta, SC, Sinha, SN & Naithani, YP (1984) Nutritional support as an adjunct therapy of advanced cancer patients. Indian Journal of Medical Research 80, 180–188.Google ScholarPubMed
Watters, JM, Kirkpatrick, SM, Morris, SB, Shamji, FM & Wells, GA (1997) Immediate postoperative enteral feeding results in impaired respiratory mechanics and decreased mobility. Annals of Surgery 226, 369–380.CrossRefGoogle ScholarPubMed
Parenteral nutrition:.Google Scholar
Abel, RM, Fischer, JE, Buckley, MJ, Barnett, GO & Austen, G (1976) Malnutrition in cardiac surgical patients. Archives of Surgery 111, 45–50.CrossRefGoogle ScholarPubMed
Bonau, RA, Ang, SD, Jeevanandam, M & Daly, JM (1984) High-branched chain amino acid solutions: relationship of composition to efficacy. Journal of Parenteral and Enteral Nutrition 8, 622–627.CrossRefGoogle ScholarPubMed
Brans, YW, Sumners, JE, Dweck, HS & Cassady, G (1974) Feeding the low birth weight infant: orally or parenterally? Preliminary results of a comparative study. Pediatrics 54, 15–22.Google ScholarPubMed
Carpentier, YA, Fetelian, D, Barroy, JP, Jaspar, N & Bracamonte, M (1985) Effect of TPN on substrate metabolism in the postoperative course. Clinical Nutrition 4, Suppl., Abstr O.23.Google Scholar
Charuhas, PM, Fosberg, KL, Bruemmer, B, Aker, SN, Leisenring, W, Seidel, K & Sullivan, KM (1997) A double-blind randomized trial comparing outpatient parenteral nutrition with intravenous hydration: effect of resumption of oral intake after marrow transplantation. Journal of Parenteral and Enteral Nutrition 21, 157–161.CrossRefGoogle ScholarPubMed
Clamon, GH, Feld, R, Evans, WK, Weiner, RS, Moran, EM, Blum, RH, Kramer, BS, Makuch, RW, Hoffman, FA & DeWys, WD (1985) Effect of adjuvant central iv hyperalimentation on the survival and response to treatment of patients with small cell lung cancer: a randomized trial. Cancer Treatment Reports 69, 167–177.Google ScholarPubMed
DeCicco, M, Panarello, G, Fantin, D, Veronesi, A, Pinto, A, Zagonel, V, Monfardini, S & Testa, V (1993) Parenteral nutrition in cancer patients receiving chemotherapy: effects of toxicity and nutritional status. Journal of Parenteral and Enteral Nutrition 17, 513–518.CrossRefGoogle Scholar
Dickinson, RJ, Ashton, MG, Axon, ATR, Smith, RC, Yeung, CK & Hill, GL (1980) Controlled trial of intravenous hyperalimentation and total bowel rest as an adjunct to the routine therapy of acute colitis. Gastroenterology 79, 1199–1204.CrossRefGoogle Scholar
Donaldson, SS, Wesley, MN, Ghavimi, F, Shils, ME, Suskind, RM & DeWys, WD (1982) A prospective randomized clinical trial of total parenteral nutrition in children with cancer. Medical and Pediatric Oncology 10, 129–139.CrossRefGoogle ScholarPubMed
Drott, C, Unsgaard, B, Schersten, T & Lundholm, K (1988) Total parenteral nutrition as an adjuvant to patients undergoing chemotherapy for testicular carcinoma: protection of body composition – a randomized, prospective study. Surgery 103, 499–506.Google ScholarPubMed
Fan, S-T, Lo, C-M, Lai, ECS, Chu, K-M, Liu, C-L & Wong, J (1994) Perioperative nutritional support in patients undergoing hepatectomy for hepatocellular carcinoma. New England Journal of Medicine 33, 1547–1552.CrossRefGoogle Scholar
Fletcher, JP & Little, JM (1986) A comparison of parenteral nutrition and early postoperative enteral feeding on the nitrogen balance after major surgery. Surgery 100, 21–24.Google ScholarPubMed
Ghavimi, F, Shils, ME, Scott, BF, Brown, M & Tamaroff, M (1982) Comparison of morbidity in children requiring abdominal radiation and chemotherapy, with and without total parenteral nutrition. Journal of Pediatrics 101, 530–537.CrossRefGoogle ScholarPubMed
Gunn, T, Reaman, G, Outerbridge, EW & Colle, E (1978) Peripheral total parenteral nutrition for premature infants with the respiratory distress syndrome: a controlled study. Journal of Pediatrics 92, 608–613.CrossRefGoogle ScholarPubMed
Gys, T, Peeters, R & Hubens, A (1990) The value of short-term peripheral parenteral nutrition after colorectal surgery: a comparative study with conventional postoperative intravenous fluid. Acta Chirurgica Belgica 90, 234–239.Google ScholarPubMed
Hansell, DT, Davies, JWL, Shenkin, A, Garden, OJ, Burns, HJG & Carter, DC (1989) The effects of an anabolic steroid and peripherally administered intravenous nutrition in the early postoperative period. Journal of Parenteral and Enteral Nutrition 13, 349–358.CrossRefGoogle ScholarPubMed
Hays, DM, Merritt, RJ, White, L, Ashley, J & Siegel, SE (1983) Effect of total parenteral nutrition on marrow recovery during induction therapy for acute nonlymphocytic leukemia in childhood. Medical and Pediatric Oncology 11, 134–140.CrossRefGoogle ScholarPubMed
Heim, ME (1986) Adjuvante parenterale ernahrung bei zytostatischer chemotherapie (Adjuvant parenteral nutrition with cytostatic chemotherapy). Infusionstherapie 13, 115–121.Google ScholarPubMed
Holter, AR & Fischer, JE (1977) The effects of perioperative hyperalimentation on complications in patients with carcinoma and weight loss. Journal of Surgical Research 23, 31–34.CrossRefGoogle ScholarPubMed
Hwang, T-L, Mou, S-C, Chen, M-F (1993) The importance of a source of sufficient protein in postoperative hypocaloric partial parenteral nutrition support. Journal of Parenteral and Enteral Nutrition 17, 254–256.CrossRefGoogle ScholarPubMed
Hyde, D & Floch, MH (1984) The effect of peripheral nutritional support and nitrogen balance in acute pancreatitis. Gastroenterology 86, 1119.Google Scholar
Hyltander, A, Drott, C, Unsgaard, B, Tolli, J, Korner, U, Arfvidsson, B & Lundholm, K (1991) The effect on body composition and exercise performance of home parenteral nutrition when given as adjunct to chemotherapy of testicular carcinoma. European Journal of Clinical Investigation 21, 413–420.CrossRefGoogle ScholarPubMed
Issell, BF, Valdivieso, M, Zaren, HA, Dudrick, SJ, Freireich, EJ, Copeland, EW & Bodey, GP (1978) Protection against chemotherapy toxicity by iv hyperalimentation. Cancer Treatment Reports 62, 1139–1143.Google ScholarPubMed
Jensen, S (1985) Clinical effects of enteral and parenteral nutrition preceding cancer surgery. Medical Oncology and Tumor Pharmacotherapy 2, 225–229.CrossRefGoogle ScholarPubMed
Jin, D, Phillips, M & Byles, JE (1999) Effects of parenteral nutrition support and chemotherapy on the phasic composition of tumor cells in gastrointestinal cancer. Journal of Parenteral and Enteral Nutrition 23, 237–241.CrossRefGoogle ScholarPubMed
Kinsella, TJ, Malcolm, AW, Bothe, A, Valerio, D & Blackburn, GL (1981) Prospective study of nutritional support during pelvic irradiation. International Journal of Radiation Oncology and Biological Physics 7, 543–548.CrossRefGoogle ScholarPubMed
Kirvela, O, Stern, RC, Askanazi, J, Doershuk, CF, Rothkopf, MM & Katz, DP (1993) Long-term parenteral nutrition in cystic fibrosis. Nutrition 9, 119–126.Google ScholarPubMed
Lorenzoni, K (1981) Postoperative infusionstherapie in der abdominalchirurgie (Postoperative infusion therapy in abdominal surgery). Wiener Medizinische Wochenschrift 131, 485–491.Google ScholarPubMed
Lough, M, Watkins, R, Campbell, M, Carr, K, Burnett, A & Shenkin, A (1990) Parenteral nutrition in bone marrow transplantation. Clinical Nutrition 9, 97–101.CrossRefGoogle ScholarPubMed
McIntyre, PB, Powell-Tuck, J, Wood, SR, Lennard-Jones, JE, Lerebours, E, Heckelsweher, P, Gaimiche, J-P & Colin, R (1986) Controlled trial of bowel rest in the treatment of severe acute colitis. Gut 27, 481–485.CrossRefGoogle ScholarPubMed
Marin, VB, Rebollo, MGJ, Castillo-Duran, CD, Lopez, MTS, Sanabria, MS, Moraga, FM, Castro, F & Barrera, FO (1999) Controlled study of early postoperative parenteral nutrition in children. Journal of Pediatric Surgery 34, 1330–1335.CrossRefGoogle ScholarPubMed
Mattioli, S, Lassari, A, Lerro, F, DiSimone, MP, Pilotti, V, Raspadori, A, D'Ovidio, F & Gozzetti, G (1993) Nutrizione parenterale totale dopo interventi di chirurgia digestiva maggiore (Total parenteral nutrition after undergoing major digestive surgery). Chirurgia 6, 129–133.Google Scholar
Melchior, J-C, Chastang, C, Gelas, P, Carbonnel, F, Zazzo, J-F, Boulier, A, Cosnes, J, Bouletreau, P & Messing, B (1996) Efficacy of 2-month total parenteral nutrition in AIDS patients: a controlled randomized prospective trial. AIDS 10, 379–384.CrossRefGoogle ScholarPubMed
Muller, JM, Keller, HW, Brenner, U, Walter, M & Holzmuller, W (1986) Indications and effects of preoperative parenteral nutrition. World Journal of Surgery 10, 53–63.CrossRefGoogle ScholarPubMed
Naveau, S, Pelletier, G, Poynard, T, Attali, P, Poitrine, A, Buffet, C, Etienne, J-P, Chaput, J-C (1986) A randomized clinical trial of supplementary parenteral nutrition in jaundiced alcoholic cirrhotic patients. Hepatology 6, 270–274.CrossRefGoogle ScholarPubMed
Neuvonen, P & Salo, M (1984) Effects of preoperative parenteral nutrition on cell-mediated immunity in malnourished patients. Clinical Nutrition 3, 197–201.CrossRefGoogle ScholarPubMed
Nixon, DW, Moffitt, S, Lawson, DH, Ansley, J, Lynn, MJ, Kutner, MH, Heymsfield, SB, Wesley, M, Chawla, R & Rudman, D (1981) Total parenteral nutrition as an adjunct to chemotherapy of metastatic colorectal cancer. Cancer Treatment Reports 65, Suppl. 5, 121–128.Google ScholarPubMed
O'Mahony, JB, McIrvine, AJ, Palder, SB, See-Young, L, Saporoschetz, IB, Wilmore, DW & Mannick, JA (1984) The effect of short term postoperative intravenous feeding upon cell-mediated immunity and serum suppressive activity in well nourished patients. Surgery, Gynecology, and Obstetrics 159, 27–32.Google ScholarPubMed
Pildes, RS, Ramamurthy, RS, Cordero, GV & Wong, PWK (1973) Intravenous supplementation of l-amino acids and dextrose in low-birth-weight infants. Journal of Pediatrics 82, 945–950.CrossRefGoogle ScholarPubMed
Popp, MB, Fisher, RI, Wesley, R, Aamodt, R & Brennan, MF (1981) A prospective randomized study of adjuvant parenteral nutrition in the treatment of advanced diffuse lymphoma: influence on survival. Surgery 90, 195–203.Google ScholarPubMed
Reilly, J, Mehta, R, Teperman, L, Cemaj, S, Tzakis, A, Yanaga, K, Ritter, P, Rezak, A & Makowka, L (1990) Nutritional support after liver transplantation: a randomized prospective study. Journal of Parenteral and Enteral Nutrition 14, 386–391.CrossRefGoogle ScholarPubMed
Roberts, S, Miller, JE & Pineiro, LA (2000) Is total parenteral nutrition beneficial in breast cancer patients after autologous marrow or blood transplantation?. Journal of Parenteral and Enteral Nutrition 24, S11–S12.Google Scholar
Samuels, ML, Selig, DE, Ogden, S, Grant, C & Brown, B (1981) Iv hyperalimentation and chemotherapy for stage III testicular cancer: a randomized study. Cancer Treatment Reports 65, 615–627.Google ScholarPubMed
Sax, HC, Warner, BW, Talamini, MA, Hamilton, FN, Bell, RH, Fischer, JE & Bower, RH (1987) Early total parenteral nutrition in acute pancreatitis: lack of beneficial effects. American Journal of Surgery 153, 117–124.CrossRefGoogle ScholarPubMed
Serrou, B, Cupissol, D, Plagne, R, Boutin, P, Chollet, P, Carcassone, Y & Michel, FB (1982) Follow-up of a randomized trial for oat cell carcinoma evaluating the efficacy of peripheral intravenous nutrition (PIVN) as adjunct treatment. Recent Results in Cancer Research 80, 246–253.CrossRefGoogle ScholarPubMed
Shamberger, RC, Brennan, MF, Goodgame, JT, Lowry, SF, Maher, MM, Wesley, RA & Pizzo, PA (1984) A prospective, randomized study of adjuvant parenteral nutrition in the treatment of sarcomas: results of metabolic and survival studies. Surgery 96, 1–12.Google ScholarPubMed
Shike, M, Russell, DM, Detsky, AS, Harrison, JE, McNeill, KG, Shepherd, FA, Feld, R, Evans, WK & Jeejeebhoy, KN (1984) Changes in body composition in patients with small-cell lung cancer. Annals of Internal Medicine 101, 303–309.CrossRefGoogle ScholarPubMed
Simms, JM, Oliver, E & Smith, JAR (1980) A study of total parenteral nutrition (TPN) in major gastric and esophageal resection for neoplasia. Journal of Parenteral and Enteral Nutrition 4, 422.Google Scholar
Simon, D & Galambos, JT (1988) A randomized controlled study of peripheral parenteral nutrition in moderate and severe alcoholic hepatitis. Journal of Hepatology 7, 200–207.CrossRefGoogle ScholarPubMed
Smith, JAR, Simms, JM, Williams, JL & Woods, HF (1984) Is total parenteral nutrition necessary after total cystectomy? – A pilot study. Clinical Nutrition 3, 55–58.CrossRefGoogle Scholar
Solassol, C, Joyeaux, H & Dubois, JB (1979) Total parenteral nutrition (TPN) with complete nutritive mixtures: an artificial gut in cancer patients. Nutrition and Cancer 1, 13–18.CrossRefGoogle Scholar
Song, Y, Kang, XM & Xia, XR (1993) Clinical observation on short term nutritional support in the treatment of advanced chronic obstructive pulmonary disease. Chung Hua Nei Ko Tsa Chih 32, 819–822.Google ScholarPubMed
Thompson, BR, Julian, TB & Stremple, JF (1981) Perioperative total parenteral nutrition in patients with gastrointestinal cancer. Journal of Surgical Research 30, 497–500.CrossRefGoogle ScholarPubMed
Vaidya, UV, Bhave, SA & Pandit, AN (1995) Parenteral nutrition (PN) in the management of very low birthweight (VLBW) babies – a randomized controlled trial. Indian Pediatrics 32, 165–170.Google ScholarPubMed
Valdivieso, M, Frankmann, C, Murphy, WK, Benjamin, RS, Barkley, HT, McMurtrey, MJ, Jeffries, DG, Welch, SR & Bodey, GP (1987) Long-term effects of intravenous hyperalimentation administered during intensive chemotherapy for small cell bronchogenic carcinoma. Cancer 59, 362–369.3.0.CO;2-J>CrossRefGoogle ScholarPubMed
Van Eys, J, Copeland, EM, Cangir, A, Taylor, G, Teitell-Cohen, B, Carter, P & Ortiz, C (1980) A clinical trial of hyperalimentation in children with metastatic malignancies. Medical and Pediatric Oncology 8, 63–73.CrossRefGoogle ScholarPubMed
Weisdorf, SA, Lysne, J, Wind, D, Haake, RJ, Sharp, HL, Goldman, A, Schissel, K, McGlave, PB, Ramsay, NK & Kersey, JH (1987) Positive effect of prophylactic total parenteral nutrition on long-term outcome of bone marrow transplantation. Transplantation 43, 833–838.CrossRefGoogle ScholarPubMed
Wu, C-W, Meng, HC, Mok, K-T, Kung, S-P, Lin, S-H, Liu, W-Y, Peng, F-K (1995) Effect of total parenteral nutrition on the postoperative outcome in aged patients with gastric cancer. Digestive Surgery 12, 164–170.CrossRefGoogle Scholar
Yamada, N, Koyama, H, Hioki, K, Yamada, T & Yamamoto, M (1983) Effect of postoperative total parenteral nutrition (TPN) as an adjunct to gastrectomy for advanced gastric carcinoma. British Journal of Surgery 70, 267–274.CrossRefGoogle ScholarPubMed
Protein-sparing therapy:.Google Scholar
Achord, JL (1987) A prospective randomized clinical trial of peripheral amino acid-glucose supplementation in acute alcoholic hepatitis. American Journal of Gastroenterology 82, 871–875.Google ScholarPubMed
Bonkovsky, HL, Fiellin, DA, Smith, GS, Slaker, DP, Simon, D & Galambos, JT (1991) A randomized, controlled trial of treatment of alcoholic hepatitis with parenteral nutrition and oxandrolone. I. Short-term effects on liver function. American Journal of Gastroenterology 86, 1200–1208.Google ScholarPubMed
Bryan, MH, Wei, P, Hamilton, JR, Chance, GW & Swyer, PR (1973) Supplemental intravenous alimentation in low-birth-weight infants. Journal of Pediatrics 82, 940–944.CrossRefGoogle ScholarPubMed
Culebras-Fernandez, JM, de la Hoz Riesco, M, Villares Garcia, C, Hurtado Fernandez-Llamazares, G, Alonos Villalba, A (1987) Improvement of the nutritional condition with hypocaloric peripheral parenteral nutrition (HPPN) in the immediate postoperative period of elective abdominal surgery. Infusionstherapie 14, 202–208.Google ScholarPubMed
Figueras, J, Puig, P, Rafecas, A, Bianchi, A, Hernandez, F, Pi, F & Colomer, J (1988) Postoperative hypocaloric parenteral nutrition. Acta Chirurgica Scandinavica 154, 435–438.Google ScholarPubMed
Figueras, J, Ramos, E., Llop, JM, San-Juan, N & Marti, J (1990) Effect of balanced amino acid solution on protein metabolism after surgery. A clinical study. Infusionstherapie 17, 100–103.Google ScholarPubMed
Figueras-Felip, J, Rafecas-Renau, A, Sitges-Serra, A, Puig-Gris, P, Pi-Siques, F, Colomer, J, Bianchi-Cardona, (1986) Does peripheral hypocaloric parenteral nutrition benefit the postoperative patient? Results of a multicentric randomized trial. Clinical Nutrition 5, 117–121.CrossRefGoogle ScholarPubMed
Freund, H, Hoover, HC, Atamian, S & Fischer, JE (1979) Infusion of the branched chain amino acids in postoperative patients. Annals of Surgery 190, 18–23.CrossRefGoogle ScholarPubMed
Garden, OJ, Smith, A, Harris, NWS, Shenkin, A, Sim, AJW & Carter, DC (1983) The effect of isotonic amino acid infusions on serum proteins and muscle breakdown following surgery. British Journal of Surgery 70, 79–82.CrossRefGoogle ScholarPubMed
Hansell, DT, Davies, JWL, Shenkin, A, Garden, OJ, Burns, HJG & Carter, DC (1989) The effects of an anabolic steroid and peripherally administered intravenous nutrition in the early postoperative period. Journal of Parenteral and Enteral Nutrition 13, 349–358.CrossRefGoogle ScholarPubMed
Hensle, TW (1978) Protein-sparing therapy in cystectomy patients. Journal of Urology 119, 355–358.CrossRefGoogle ScholarPubMed
Hogbin, BM, Smith, AM & Craven, AH (1984) An evaluation of peripheral essential amino acid infusion following major surgery. Journal of Parenteral and Enteral Nutrition 8, 511–514.CrossRefGoogle ScholarPubMed
Hwang, T-L, Mou, S-C, Chen, M-F (1993) The importance of a source of sufficient protein in postoperative hypocaloric partial parenteral nutrition support. Journal of Parenteral and Enteral Nutrition 17, 254–256.CrossRefGoogle ScholarPubMed
Hyde, D & Floch, MH (1984) The effect of peripheral nutritional support and nitrogen balance in acute pancreatitis. Gastroenterology 86, 1119.Google Scholar
Jimenez Jimenez, FJ, Ortiz Leyba, C, Jimenez Jimenez, LM, Garcia Valdecasas, MS, Garnacho Montero, J (1995) Study of hypocaloric peripheral parenteral nutrition in postoperative patients (Europan project). Clinical Nutrition 14, 88–96.CrossRefGoogle Scholar
Lopez-Hellin, J, Lopez-Lara, M, Mercader, S, Gemar, E, Garcia-Arumi, E, Sabin, P, Baena, JA & Schwartz, S (1997) Early curbing of protein hypercatabolism in postoperative patients by nutritional support with glucose plus amino acids, but not with glucose alone. Clinical Nutrition 16, 67–73.CrossRefGoogle Scholar
Mezey, E, Caballeria, J, Mitchell, MC, Pares, A, Herlong, HF & Rodes, J (1991) Effect of parenteral amino acid supplementation on short-term and long-term outcomes in severe alcoholic hepatitis: a randomized controlled trial. Hepatology 14, 1090–1096.CrossRefGoogle ScholarPubMed
Nasrallah, SM & Galambos, JT (1980) Aminoacid therapy of alcoholic hepatitis. Lancet i, 1276–1277.CrossRefGoogle Scholar
Sitges-Serra, A, Figueras-Felip, J, Alastrue-Vidal, A, Jaurrieta-Mas, E, Rafecas-Renau, A (1986) A randomized trial on the effect of isotonic amino acid infusion on postoperative complications and short life plasma protein concentrations. Infusionstherapie 13, 210–214.Google ScholarPubMed