title: Intradialytic blood volume monitoring in ambulatory hemodialysis patients: a randomized trial.
abstract: Complications related to inadequate volume management are common during hemodialysis. This trial tested the hypothesis that availability of an intradialytic blood volume monitoring (IBVM) device improves fluid removal, reducing morbidity. A six-center, randomized trial with 6 mo of intervention comparing IBVM using Crit-Line versus conventional clinical monitoring was conducted. The average rate of non-access-related hospitalizations was compared across treatment groups using Poisson regression. Mortality analysis used the Kaplan Meier method. A total of 227 patients were randomized to Crit-Line, and 216 were randomized to conventional monitoring. Both groups had similar baseline characteristics. During the study, no differences in weight, BP, or number of dialysis-related complications were observed. There were 120 and 81 non-access-related hospitalizations in the Crit-Line and conventional monitoring groups. The adjusted risk ratio for non-access-related and access-related hospitalization was 1.61 (95% confidence interval 1.15 to 2.25; P = 0.01) and 1.52 (95% confidence interval 1.02 to 2.28; P = 0.04) for the Crit-Line monitoring group. Mortality was 8.7% in the Crit-Line monitoring group and 3.3% in the conventional group (P = 0.021). Standardized mortality ratios comparing the Crit-Line and conventional monitoring groups to the prevalent hemodialysis population were 0.77 (NS) and 0.26 (P < 0.001). Hospitalization rates were 1.51 and 1.03 events/yr in the Crit-Line and standard monitoring groups, compared with 2.01 for the prevalent hemodialysis population. IBVM was associated with higher nonvascular and vascular access-related hospitalizations and mortality compared with conventional monitoring. The atypically low hospitalization and mortality rates for the conventional monitoring group suggest that these findings should be generalized to the US hemodialysis population with caution.
authors.affiliation: Duke University Medical Center, Box 3646, Durham, NC 27710, USA.
authors.forename: Donal N
authors.initials: DN
authors.lastname: Reddan
authors.forename: Lynda Anne
authors.initials: LA
authors.lastname: Szczech
authors.forename: Vic
authors.initials: V
authors.lastname: Hasselblad
authors.forename: Edmund G
authors.initials: EG
authors.lastname: Lowrie
authors.forename: Robert M
authors.initials: RM
authors.lastname: Lindsay
authors.forename: Jonathan
authors.initials: J
authors.lastname: Himmelfarb
authors.forename: Robert D
authors.initials: RD
authors.lastname: Toto
authors.forename: John
authors.initials: J
authors.lastname: Stivelman
authors.forename: James F
authors.initials: JF
authors.lastname: Winchester
authors.forename: Linda A
authors.initials: LA
authors.lastname: Zillman
authors.forename: Robert M
authors.initials: RM
authors.lastname: Califf
authors.forename: William F
authors.initials: WF
authors.lastname: Owen
mesh_terms: D000328:Adult; D000368:Aged; D001810:Blood Volume; D001811:Blood Volume Determination / Q000379:methods*; D005260:Female; D006801:Humans; D007676:Kidney Failure, Chronic / Q000628:therapy; D008297:Male; D008875:Middle Aged; D018670:Monitoring, Ambulatory / Q000379:methods*; D006435:Renal Dialysis / Q000009:adverse effects*; D014883:Water-Electrolyte Imbalance / Q000175:diagnosis / Q000209:etiology / Q000517:prevention & control*