BP in Dialysis: Results of a Pilot Study

Abstract

The optimal BP target for patients receiving hemodialysis is unknown. We randomized 126 hypertensive patients on hemodialysis to a standardized predialysis systolic BP of 110-140 mmHg (intensive arm) or 155-165 mmHg (standard arm). The primary objectives were to assess feasibility and safety and inform the design of a full-scale trial. A secondary objective was to assess changes in left ventricular mass. Median follow-up was 365 days. In the standard arm, the 2-week moving average systolic BP did not change significantly during the intervention period, but in the intensive arm, systolic BP decreased from 160 mmHg at baseline to 143 mmHg at 4.5 months. From months 4-12, the mean separation in systolic BP between arms was 12.9 mmHg. Four deaths occurred in the intensive arm and one death occurred in the standard arm. The incidence rate ratios for the intensive compared with the standard arm (95% confidence intervals) were 1.18 (0.40 to 3.33), 1.61 (0.87 to 2.97), and 3.09 (0.96 to 8.78) for major adverse cardiovascular events, hospitalizations, and vascular access thrombosis, respectively. The intensive and standard arms had similar median changes (95% confidence intervals) in left ventricular mass of -0.84 (-17.1 to 10.0) g and 1.4 (-11.6 to 10.4) g, respectively. Although we identified a possible safety signal, the small size and short duration of the trial prevent definitive conclusions. Considering the high risk for major adverse cardiovascular events in patients receiving hemodialysis, a full-scale trial is needed to assess potential benefits of intensive hypertension control in this population.

Comparison of characteristics of centers practicing incremental vs. conventional approaches to hemodialysis delivery – postdialysis recovery time and patient survival

“…Cardiovascular comorbidity is common in HD patients and further complicates interpretation of blood pressure targets. Extrapolating targets from the general population is unlikely to be helpful and may be harmful, as evidenced by a recent pilot trial designed to achieve lower blood pressures in dialysis patients which reported increased intradialytic hypotensive episodes in patients randomized to achieve lower blood pressure targets . As such it is likely that an individualized approach is required.…”

Mineral and bone disorders in conventional hemodialysis: Challenges and solutions

“…While observational studies found higher hemoglobin levels to be associated with better survival in patients with CKD, many RCTs, including the Normal Hematocrit Study, showed contradictory findings. This is also true for hypertension targets in patients on dialysis . Thus, the EPISODE study, launched in 2017, may prove to be interesting.…”

Blood pressure control in conventional hemodialysis

“…The feasibility and safety of intensive BP‐lowering was tested in the Blood Pressure In Dialysis (BID) trial, in which 126 hypertensive hemodialysis patients were randomized to a lower predialysis systolic BP target of 110‐140 mm Hg (intensive arm) vs a higher predialysis systolic BP target of 155‐165 mm Hg (standard arm). Between baseline and month 4, systolic BP fell from 160 to 145 mm Hg in the intensive arm, but remained unchanged in the standard arm.…”

“…Although the exact levels at which BP should be targeted remain elusive, meta‐analyses of randomized trials showed that BP‐lowering with the use of antihypertensive therapy improves clinical outcomes, particularly if patients are hypertensive . A recent trial randomizing hemodialysis patients to lower versus higher predialysis BP targets suggested that intensive BP‐lowering in conventional hemodialysis is feasible and does not exacerbate the risk of serious adverse events . Hypertension should be managed first by nonpharmacological strategies aiming to control sodium and volume overload.…”