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Intradialytic Blood Volume Monitoring in Ambulatory Hemodialysis Patients: A Randomized Trial

Donal N. Reddan^*,,, Lynda Anne Szczech^*,, Vic Hasselblad^*, Edmund G. Lowrie, Robert M. Lindsay^||, Jonathan Himmelfarb^¶, Robert D. Toto^#, John Stivelman^**, James F. Winchester^,, Linda A. Zillman^*, Robert M. Califf^*, and William F. Owen, Jr^,

^* Duke Clinical Research Institute, Duke University Medical Center, Durham, North Carolina; University College Galway, Galway, Ireland; Duke University Medical Center, Department of Medicine, Division of Nephrology, Durham, North Carolina; Hema Metrics Inc., Kaysville, Utah; ^|| London Health Sciences Center and University of Western Ontario, London, Ontario, Canada; ^¶ Maine Medical Center, Portland, Maine; ^# University of Texas Southwestern Medical Center at Dallas, Dallas, Texas; ^** Northwest Kidney Centers, Seattle, Washington; Beth Israel Medical Center, New York, New York; RenalTech International, New York, New York; and; University of Tennessee, Memphis, Tennessee

Address correspondence to: Dr. Lynda Szczech, Duke University Medical Center, Box 3646, Durham, NC 27710. Phone: 919-668-8008; Fax: 919-668-7128; E-mail: szcze001{at}mc.duke.edu

Received for publication December 7, 2004. Accepted for publication April 25, 2005.

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.

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Copyright © 2008 by the American Society of Nephrology. Online ISSN: 1533-3450 Print ISSN: 1046-6673