Hemodynamic Effects of Low vs. High Dialysate Temperature or Bicarbonate Concentration in Chronic Hemodialysis Patients
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University of Aarhus
- Enrollment
- 16
- Locations
- 1
- Primary Endpoint
- Blood pressure (BP)
Study Overview
Brief Summary
To elucidate the role of dialysate temperature and bicarbonate on hemodynamic parameters, plasma pH and electrolytes that potentially mediate this effect, the investigators wish to conduct a single-blinded, randomized, controlled, crossover study, specifically examining the effects of
- A fixed low temperature dialysate of 35°C compared to a fixed dialysate temperature of 37°C.
- A low dialysate bicarbonate concentration of 30 mmol/L compared to a high dialysate bicarbonate concentration of 38 mmol/L.
Detailed Description
Background
Intradialytic hypotension (IDH) is a common complication of hemodialysis (HD) and is considered one of the most frequent complications with a prevalence between 10-12% depending on the definition of IDH (1). IDH has been associated with inefficient dialysis (2), vascular access thrombosis (3) and mortality (4,5).
Orthostatic hypotension (OH) is another common complication in HD with a prevalence around 42% in patients initiating HD treatment (6). OH is significantly associated with worse outcome in HD patients in terms of an increased two-year mortality (4) and increased risk of all-cause death (6).
Understanding the mechanisms underlying IDH and OH has the potential to optimize HD treatment, in order to minimize the occurrence of IDH and OH, potentially improving not only patient mortality and morbidity but also the everyday comfort of chronic HD patients when receiving dialysis treatment.
This study will investigate the hemodynamic effect of alterations in dialysate bicarbonate and dialysate temperature.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Masking Description
Temperature or bicarbonate settings will not be revealed to participants during the study.
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Regular dialysis (HD or HDF) therapy for >3 months
- •Age >18 years
- •Stable and functional arteriovenous (AV)-fistula
- •Able to achieve a dialysis blood flow > 250 mL
- •Able to stand up for a minimum of 10 min
- •Able to undergo a 4 hour dialysis session without eating, drinking or sleeping
- •Proven cabable of cumulative ultrafiltration of 2% of end-dialytic weight (EDW)
- •Able to give informed consent to participation in the study
- •Hematocrit >30%
- •BMI >18 and <35
Exclusion Criteria
- •Central venous catheter for HD or HDF
- •Recirculation in AV-fistula
- •Acute myocardial infarction within 3 months
- •Atrial fibrillation
- •Active malignant or infectious diseases
- •Cerebrovascular incident within 3 months
- •Pregnancy
- •Alcohol or drug abuse
- •History of interruptions during HD or untimely termination of HD treatment
Arms & Interventions
Low temperature
Dialysate temperature
Intervention: Low dialysate temperature (Other)
High temperature
Dialysate temperature
Intervention: High dialysate temperature (Other)
Low bicarbonate
Dialysate bicarbonate concentration
Intervention: Low dialysate bicarbonate concentration (Other)
High bicarbonate
Dialysate bicarbonate concentration
Intervention: High dialysate bicarbonate concentration (Other)
Outcomes
Primary Outcomes
Blood pressure (BP)
Time Frame: 4 weeks
SBP (mmHg), Mean BP (mmHg) and Ortostatic BP (mmHg)
Secondary Outcomes
- Intradialytic stroke volume(4 weeks)
- Intradialytic cardiac output(4 weeks)
- Intradialytic hypotension (IDH)(4 weeks)
- Intradialytic total peripheral resistance(4 weeks)
- Intradialytic heart rate(4 weeks)
- Plasma magnesium(4 weeks)
- Ortostatic hypotension (OH)(4 weeks)
- Intradialytic central blood volume(4 weeks)
- Intradialytic mean arterial blood pressure(4 weeks)
- Plasma calcium(4 weeks)
- Plasma potassium(4 weeks)