PMID- 11018567
OWN - NLM
STAT- MEDLINE
DCOM- 20001019
LR  - 20220311
IS  - 0197-2456 (Print)
IS  - 0197-2456 (Linking)
VI  - 21
IP  - 5
DP  - 2000 Oct
TI  - Design and statistical issues of the hemodialysis (HEMO) study.
PG  - 502-25
AB  - The Hemodialysis Study is a multicenter clinical trial of hemodialysis 
      prescriptions for patients with end stage renal disease. Participants from over 
      65 dialysis facilities associated with 15 clinical centers in the United States 
      are randomized in a 2 x 2 factorial design to dialysis prescriptions targeted to 
      a standard dose or a high dose, and to either low or high flux membranes. The 
      primary 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 study 
      investigators, uses a blinded review system to classify causes of death and 
      hospitalizations related to the major secondary outcomes. The dialysis dose 
      intervention is directed by the Data Coordinating Center using urea kinetic 
      modeling programs that analyze results from dialysis treatments to monitor 
      adherence to the study targets, adjust suggested dialysis prescriptions, and 
      assist in trouble-shooting problems with the delivery of dialysis. The study 
      design has adequate power to detect reductions in mortality rate equal to 25% of 
      the projected baseline mortality rate for both of the interventions.
FAU - Greene, T
AU  - Greene T
AD  - Department of Biostatistics and Epidemiology, Cleveland Clinic Foundation, 
      Cleveland, OH 44195, USA. tgreene@bio.ri.ccf.org
FAU - Beck, G J
AU  - Beck GJ
FAU - Gassman, J J
AU  - Gassman JJ
FAU - Gotch, F A
AU  - Gotch FA
FAU - Kusek, J W
AU  - Kusek JW
FAU - Levey, A S
AU  - Levey AS
FAU - Levin, N W
AU  - Levin NW
FAU - Schulman, G
AU  - Schulman G
FAU - Eknoyan, G
AU  - Eknoyan G
LA  - eng
GR  - M01 RR000052/RR/NCRR NIH HHS/United States
GR  - U01 DK045381/DK/NIDDK NIH HHS/United States
GR  - U01 DK045386/DK/NIDDK NIH HHS/United States
PT  - Clinical Trial
PT  - Controlled Clinical Trial
PT  - Journal Article
PT  - Research Support, U.S. Gov't, P.H.S.
PL  - United States
TA  - Control Clin Trials
JT  - Controlled clinical trials
JID - 8006242
SB  - IM
MH  - Humans
MH  - Kidney Failure, Chronic/*therapy
MH  - Models, Statistical
MH  - Multicenter Studies as Topic
MH  - *Randomized Controlled Trials as Topic
MH  - *Renal Dialysis
MH  - *Research Design
EDAT- 2000/10/06 11:00
MHDA- 2000/10/21 11:01
CRDT- 2000/10/06 11:00
PHST- 2000/10/06 11:00 [pubmed]
PHST- 2000/10/21 11:01 [medline]
PHST- 2000/10/06 11:00 [entrez]
AID - S0197245600000623 [pii]
AID - 10.1016/s0197-2456(00)00062-3 [doi]
PST - ppublish
SO  - Control Clin Trials. 2000 Oct;21(5):502-25. doi: 10.1016/s0197-2456(00)00062-3.