Articles: critical-illness.
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The Food and Drug Administration (FDA) is issuing final regulations under which the agency will accelerate approval of certain new drugs and biological products for serious or life-threatening illnesses, with provisions for any necessary continued study of the drugs' clinical benefits after approval or with restrictions on use, if necessary. These new procedures are intended to provide expedited marketing of drugs for patients suffering from such illnesses when the drugs provide meaningful therapeutic benefit compared to existing treatment. Accelerated approval will be considered in two situations: (1) When approval can be reliably based on evidence from adequate and well-controlled studies of the drug's effect on a surrogate endpoint that reasonably suggests clinical benefit or on evidence of the drug's effect on a clinical endpoint other than survival or irreversible morbidity, pending completion of studies to establish and define the degree of clinical benefits to patients; and (2) when FDA determines that a drug, effective for the treatment of a disease, can be used safely only if distribution or use is modified or restricted. Drugs or biological products approved under these procedures will have met the requisite standards for safety and effectiveness under the Federal Food, Drug and Cosmetic Act (the act) or the Public Health Service Act (the PHS Act) and, thus, will have full approval for marketing.
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Critical illness, surgery and hypocaloric feeding are accompanied by a high rate of total body nitrogen loss. Loss of body protein, occurring despite adequate nutrition, results in increased incidence of infection, poor wound healing, skeletal muscle weakness and increased mortality. Growth hormone (GH) administration together with nutritional support attenuates protein catabolism. This review focuses on normal GH physiology and the administration of GH in adult catabolic patients.
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Critical care medicine · Dec 1992
Pediatric risk of mortality scoring overestimates severity of illness in infants.
To validate Pediatric Risk of Mortality (PRISM) scoring in infants and children admitted for intensive care. ⋯ In our center, PRISM scoring overestimates severity of illness in infants. PRISM scoring is not institutionally independent and therefore, at present, a comparison between units may not be justified. A reappraisal of the parameter ranges for infants is suggested.
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Crit Care Nurs Clin North Am · Dec 1992
Needs of families of critically ill patients: state of the science and future directions.
This article provides an overview of the needs of families of critically ill patients and offers suggestions for future research. Continuous, systematic study about the needs of families of critically ill patients is necessary for nursing to be responsive to the health care needs of society in the 21st century.
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The purpose of this article is to provide an overview of completed studies that consider visitors in critical care areas. Studies from coronary care, intensive care, pediatric PACUs, and adult PACUs are reviewed.