N/A
N=19
Conventional Hemodialysis vs. Short Daily Hemodialysis (6 Days / Week) and Mechanisms of Blood Pressure Control
End Stage Renal Disease
Bottom Line
View on ClinicalTrials.gov: NCT00759967 ↗Enrolled (actual)
19
Serious AEs
2.6%
Results posted
Aug 2017
Primary outcome: Primary: Mean Systolic Blood Pressure Over the Third Month of Each Treatment Arm — 139; 142 mm Hg
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Microneurography (Procedure); Bioimpedance testing (Procedure)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Ottawa Hospital Research Institute
- Primary completion
- Jun 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Systolic Blood Pressure Over the Third Month of Each Treatment Arm |
139; 142 | — |
| SECONDARY To Determine if the Mechanism by Which Short Daily Hemodialysis is Associated With Changes in Extracellular Fluid Volume |
15.4; 15.2 | — |
| SECONDARY To Determine if Short Daily Hemodialysis, Compared to Conventional Hemodialysis Maintains Metabolic Homeostasis |
1.61; 1.61; 1.58; 1.82 | — |
| SECONDARY To Determine if the Enhance Control of Blood Pressure With Daily Hemodialysis Compare to Conventional Hemodialysis is Associated With a Reduction in Oxidative Stress. |
2.3; 2.3; 2.0; 2.4 | — |
| SECONDARY To Determine Patient Modality Preference. |
— | — |
| SECONDARY To Determine if the Enhance Control of Blood Pressure With Daily Hemodialysis Compare to Conventional Hemodialysis is Associated With a Reduction in Markers of Inflammation |
1.55; 1.55; 1.52; 1.45 | — |
Summary
More than 80% of patients with end stage renal disease have hypertension; 70% of whom are poorly controlled using conventional Hemodialysis therapy. An expanded extracellular fluid volume and an increase in peripheral vascular resistance as a result of hemodynamic/trophic effects of an increased sympathetic nerve activity, angiotensin II, asymmetrical dimethyl arginine, and decreased nitric oxide are the most frequently quoted mechanisms contributing to hypertension in this population. The intermittent nature of conventional hemodialysis treatments (4 hours, 3 days/week) results in the majority of patients having a sustained expansion of the extracellular fluid volume that likely contributes to the activation of neurohormonal pathways. However, daily therapy including short daily hemodialysis (2 hours, 6 days/week) and nocturnal hemodialysis (6-8 hours, 5-6 days/week) improve or even normalize blood pressure. Short daily hemodialysis appears to improve blood pressure secondary to a reduction in extracellular fluid volume (7,8) whereas the improvement in blood pressure with nocturnal hemodialysis occurs by a reduction in peripheral vascular resistance (8,9,10). This is consistent with the Katzarski et al experience (7-8 hours, 3 days/week) and one randomized controlled trial in which blood pressure control was due to normalization of extracellular fluid volume in some patients and a reduction in peripheral vascular resistance in others. The majority of the studies in daily dialysis are observational, do not include a run-in period to optimize blood pressure management and have not explored the mechanisms of improvement in blood pressure in detail. We have designed a 9 month study to determine if the mechanism by which short daily hemodialysis is associated with an improvement in blood pressure control is secondary to changes in sympathetic nervous system activity and/ or extracellular fluid volume. Additionally we would like to explore the potential impact of short daily dialysis, compared to conventional dialysis, on markers of inflammation and oxidative stress in detail.
Eligibility Criteria
Inclusion Criteria
- Systolic Hypertension
- They are able to make the time commitment for daily therapy
- They are capable of giving informed consent.
Exclusion Criteria
- They are expected to receive a transplant within the next 12 months
- If they are considering a switch to peritoneal dialysis
- They are not expected to survive 12 months
- They have infections that require isolation (Vancomycin Resistant Enterococcus, Methicillin Resistant Staphylococcus Aureus, Hepatitis B)
- They have known symptomatic dilated cardiomyopathy (New York Association Class II or III with left ventricle ejection fraction of <0.35
Data sourced from ClinicalTrials.gov (NCT00759967). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.