PMID- 23377167
OWN - NLM
STAT- MEDLINE
DCOM- 20140324
LR  - 20211021
IS  - 1538-2990 (Electronic)
IS  - 0002-9629 (Print)
IS  - 0002-9629 (Linking)
VI  - 347
IP  - 2
DP  - 2014 Feb
TI  - Design of the Blood Pressure Goals in Dialysis pilot study.
PG  - 125-30
LID - 10.1097/MAJ.0b013e31827daee5 [doi]
AB  - BACKGROUND: Cardiovascular disease (CVD) is markedly increased among hemodialysis 
      (HD) patients. Optimizing blood pressure (BP) among HD patients may present an 
      important opportunity to reduce the disparity in CVD rates between HD patients 
      and the general population. The optimal target predialysis systolic BP (SBP) 
      among HD patients is unknown. Current international guidelines, calling for a 
      predialysis SBP < 140 mm Hg, are based on the opinion and extrapolation from the 
      general population. Existing randomized controlled trials (RCTs) were small and 
      did not include prespecified BP targets. METHODS: The authors described the 
      design of the Blood Pressure in Dialysis (BID) Study, a pilot, multicenter RCT 
      where HD patients are randomized to either a target-standardized predialysis SBP 
      of 110 to 140 mm Hg or 155 to 165 mm Hg. This is the first study to randomize HD 
      patients to 2 different SBP targets. RESULTS: Primary outcomes are feasibility 
      and safety. Feasibility parameters include recruitment and retention rates, 
      adherence with prescribed BP measurements and achievement and maintenance of 
      selected BP targets. Safety parameters include rates of hypotension and other 
      adverse and serious adverse events. The authors obtained preliminary data on 
      changes in left ventricular mass, aortic pulse wave velocity, vascular access 
      thromboses and health-related quality of life across study arms, which may be the 
      secondary outcomes in the full-scale study. CONCLUSIONS: The data acquired in the 
      pilot RCT will determine the feasibility and safety and inform the design of a 
      full-scale trial, powered for hard outcomes, which may require 2000 participants.
FAU - Gul, Ambreen
AU  - Gul A
AD  - Department of Medicine (AG, AH, BH, EB, PZ), University of New Mexico, 
      Albuquerque, New Mexico; Department of Medicine (DM), Tufts University, Boston, 
      Massachusetts; Department of Quantitative Health Sciences (JG), Cleveland Clinic 
      Foundation, Cleveland, Ohio; Department of Medicine (JC), Boston University, 
      Boston, Massachusetts; Dialysis Clinic, Inc (SP, PZ), Quality Management, 
      Albuquerque, New Mexico; National Institutes of Health (JWK), NIDDK, Bethesda, 
      Maryland; and Department of Medicine (MU), University of Pittsburgh, Pittsburgh, 
      Pennsylvania.
FAU - Miskulin, Dana
AU  - Miskulin D
FAU - Gassman, Jennifer
AU  - Gassman J
FAU - Harford, Antonia
AU  - Harford A
FAU - Horowitz, Bruce
AU  - Horowitz B
FAU - Chen, Joline
AU  - Chen J
FAU - Paine, Susan
AU  - Paine S
FAU - Bedrick, Edward
AU  - Bedrick E
FAU - Kusek, John W
AU  - Kusek JW
FAU - Unruh, Mark
AU  - Unruh M
FAU - Zager, Philip
AU  - Zager P
CN  - BID Pilot Study Investigators
LA  - eng
GR  - R01 DK083424/DK/NIDDK NIH HHS/United States
GR  - R01 DK083424-01/DK/NIDDK NIH HHS/United States
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PT  - Research Support, N.I.H., Extramural
PT  - Research Support, Non-U.S. Gov't
PL  - United States
TA  - Am J Med Sci
JT  - The American journal of the medical sciences
JID - 0370506
RN  - 0 (Antihypertensive Agents)
SB  - IM
MH  - Antihypertensive Agents/therapeutic use
MH  - *Blood Pressure
MH  - Humans
MH  - Hypertension/*drug therapy
MH  - Pilot Projects
MH  - *Renal Dialysis
MH  - *Research Design
PMC - PMC3647384
MID - NIHMS429447
EDAT- 2013/02/05 06:00
MHDA- 2014/03/25 06:00
PMCR- 2015/02/01
CRDT- 2013/02/05 06:00
PHST- 2013/02/05 06:00 [entrez]
PHST- 2013/02/05 06:00 [pubmed]
PHST- 2014/03/25 06:00 [medline]
PHST- 2015/02/01 00:00 [pmc-release]
AID - S0002-9629(15)30410-9 [pii]
AID - 10.1097/MAJ.0b013e31827daee5 [doi]
PST - ppublish
SO  - Am J Med Sci. 2014 Feb;347(2):125-30. doi: 10.1097/MAJ.0b013e31827daee5.