Proposed clinical trials in the evaluation of intradialytic parenteral nutrition.

New revised policies relating to intradialytic parenteral nutrition (IDPN) reimbursement by Medicare have made it difficult, if not impossible, to qualify malnourished hemodialysis patients for this potentially useful therapy. These policies were adopted by Medicare because of a lack of studies that provide clear documentation of the medical benefits of IDPN or their cost-effectiveness. We propose a limited study of the role of IDPN with and without anabolic growth factors to improve predefined nutritional parameters and document its cost-effectiveness by monitoring hospitalization and mortality. The proposed study will be multicenter, prospective, limited to severely malnourished patients, and will include a control group that would receive standard of care.