Safety of Dialysate Sodium Individualization in Hemodialysis Patients With Intradialytic Hypotension
| Status: | Terminated |
|---|---|
| Conditions: | Renal Impairment / Chronic Kidney Disease, Cardiology |
| Therapuetic Areas: | Cardiology / Vascular Diseases, Nephrology / Urology |
| Healthy: | No |
| Age Range: | 18 - 90 |
| Updated: | 7/27/2016 |
| Start Date: | October 2005 |
| End Date: | October 2008 |
Hemodynamic Changes During Dialysate Sodium Individualization in Hemodialysis Patients
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.
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.
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.
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.
Inclusion Criteria:
- Hemodialysis patients with intradialytic hypotension
Exclusion Criteria:
- Atrial fibrillation
- Bilateral upper extremity arteriovenous access
- Average plasma sodium >139
We found this trial at
1
site
VA Connecticut Healthcare System VA Connecticut encompasses an inpatient facility and Ambulatory Care Center in...
Click here to add this to my saved trials
