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
| Autor: | C P Page, James L. Mullen, W O Williford, G F Reinhardt, Gordon P. Buzby, Lon O. Crosby, O L Peterson |
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| Rok vydání: | 1988 |
| Předmět: |
medicine.medical_specialty
Medicine (miscellaneous) Context (language use) Pilot Projects Preoperative care law.invention Random Allocation Postoperative Complications Randomized controlled trial law Preoperative Care medicine Humans Prospective Studies Intensive care medicine Protocol (science) Clinical Trials as Topic Nutrition and Dietetics Surrogate endpoint business.industry Nutrition Disorders Clinical trial Parenteral nutrition Sample size determination Research Design Surgical Procedures Operative Parenteral Nutrition Total business |
| Zdroj: | The American journal of clinical nutrition. 47 |
| ISSN: | 0002-9165 |
| Popis: | 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. Am J C/in Nutr l988;47:357-65. |
| Databáze: | OpenAIRE |
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