Home
Search
Study Topics
Glossary
|
|
|
|
|
|
Sponsored by: |
Yale University |
---|---|
Information provided by: | Yale University |
ClinicalTrials.gov Identifier: | NCT00237783 |
Low blood pressure (hypotension) during dialysis afflicts approximately 25% of hemodialysis patients. In this pilot study, we will evaluate the safety and effects of individualizing the sodium concentration in the dialysate according to the patient's own plasma sodium levels. We hypothesize that patients will have less thirst and less weight gain during the intervention leading to easier fluid removal and less episodes of hypotension.
Condition | Intervention |
---|---|
Hemodialysis Hypotension |
Drug: dialysate sodium concentration |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Crossover Assignment, Safety/Efficacy Study |
Official Title: | Hemodynamic Changes During Dialysate Sodium Individualization in Hemodialysis Patients |
Estimated Enrollment: | 7 |
Study Start Date: | October 2005 |
Study Completion Date: | October 2008 |
Primary Completion Date: | October 2008 (Final data collection date for primary outcome measure) |
Hypertension and intradialytic hypotension are common complications in patients on chronic maintenance hemodialysis (HD). Sodium balance is important in mediating both processes. Recent evidence shows that individualization of the sodium concentration in the dialysate to match the patient's own serum sodium results in less thirst, less interdialytic weight gain, less HD-related symptoms, and better blood pressure control. In this project we plan to evaluate the safety and tolerability of sodium individualization in hypotension-prone patients in order to generate pilot data for a larger study in patients with intradialytic hypotension. In this protocol, we will recruit 7 hypotension-prone subjects. We will use an open-label cross-over design with randomized blocks. After a 3-week baseline period where pre-HD serum sodium will be measured weekly to establish each patient's average serum sodium, subjects will be randomized to 2 weeks on standard dialysate sodium (140 mmol/L) or individualized dialysate sodium (same concentration as the average pre-HD serum sodium during the baseline period), then crossed over to the other for another 2 weeks (total study period 7 weeks, 2 weeks baseline, 4 weeks intervention). The remainder of the dialysis prescription, prescribed dry weight and vasoactive drugs will remain unchanged throughout the study. Clinical information, pre/intra/post-HD blood pressure and hemodynamics (cardiac output and systemic vascular resistance), and the frequency and severity of intradialytic symptoms related to hypotension will be collected on HD sessions during the 4 weeks of intervention.
Ages Eligible for Study: | 18 Years to 90 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, Connecticut | |
VA Connecticut Healthcare System | |
West Haven, Connecticut, United States, 06516 |
Principal Investigator: | Aldo J Peixoto, MD | Yale University and VA Connecitcut Healthcare System |
Responsible Party: | VA Connecticut ( Aldo Peixoto, MD ) |
Study ID Numbers: | AP0008 |
Study First Received: | October 7, 2005 |
Last Updated: | October 3, 2008 |
ClinicalTrials.gov Identifier: | NCT00237783 |
Health Authority: | United States: Institutional Review Board |
Renal dialysis Hypotension Dialysis solutions |
Hypotension Vascular Diseases |
Cardiovascular Diseases |