Design and statistical issues of the Hemodialysis (HEMO) Study

The Hemodialysis Study is a multicenter clinical trial of hemodialysis pres criptions for patients with end stage renal disease. Participants from over 65 dialysis facilities associated with 15 clinical centers in the United S tates are randomized in a 2 X 2 factorial design to dialysis prescriptions targeted to a standard dose (equilibrated Kt/V = 1.05) or a high dose (equi librated Kt/V = 1.45), and to either low or high flux membranes. The primar y outcome variable is mortality; major secondary outcomes are defined based on hospitalizations due to cardiovascular or infectious complications, and on the decline of serum albumin. The Outcome Committee, consisting of stud y investigators, uses a blinded review system to classify causes of death a nd hospitalizations related to the major secondary outcomes;The dialysis do se intervention is directed by the Data Coordinating Center using urea kine tic modeling programs that analyze results from dialysis treatments to moni tor adherence to the study targets, adjust suggested dialysis prescriptions , and assist in trouble-shooting problems with the delivery of dialysis. Th e study design has adequate power to detect reductions in mortality rate eq ual to 25% of the projected baseline mortality rate for both of the interve ntions. (C) Elsevier Science Inc. 2000.