Clinical trial NCT01371890: Mechanisms and Treatment of Intradialytic Hypertension - Sodium
Official title: Mechanisms and Treatment of Intradialytic Hypertension - Sodium
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hemodialysis
End-stage Renal Disease
Hypertension
Intradialytic Hypertension
Keywords: hemodialysis
end-stage renal disease
hypertension
Lead sponsor: University of Texas Southwestern Medical Center
Sponsor class: OTHER
First posted: 2011-06-13
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CROSSOVER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Our study population will include up to 45 ESRD patients whose BP increases during hemodialysis. Patients who dialyze at any of the 3 UT Southwestern-affiliated dialysis units will be screened for possible enrollment.

Brief summary: The purpose of this study is to determine the role of dialysate exposure and fluid removal during hemodialysis in the pathophysiology of intradialytic hypertension.

Detailed description: Specific Aim #1 To determine in a crossover study of 15 maintenance hemodialysis patients with intradialytic hypertension whether standard dialysis with ultrafiltration (dialysate Na of 140), dialysis without ultrafiltration (dialysate Na of 140), or ultrafiltration alone (no dialysate) is associated with the an increase in systolic blood pressure during hemodialysis

Specific Aim #2 To determine in a crossover study of 15 maintenance hemodialysis with intradialytic hypertension whether standard dialysis with ultrafiltration, dialysis without ultrafiltration, or ultrafiltration alone is associated with change in either endothelin-1 or nitric oxide during hemodialysis

SUBSTUDY AIMS

Specific Aim #1 To determine in a randomized 3-week, 2 period crossover study of 15 maintenance hemodialysis patients with intradialytic hypertension whether high vs low dialysate-to-serum Na gradients impairs release of NO, increases ET-1 or causes an acute intradialytic increase in systolic BP,.

Specific Aim #2 TO determine in a randomized 16-week, 2-period crossover study of 30 hemodialysis patients with intradialytic hypertension the effects of 8 weeks of high dialysate-to-plasma Na gradients to 8-weeks of low Na gradients on EC function (FMD and ADMA) and 44 hour ambulatory BP.

Eligibility criteria: Inclusion Criteria:

* on hemodialysis \> 30 days
* male and female participants, aged 18 to 85 years old, of all races and ethnic origin
* ability to provide informed consent
* Primary nephrologist deems patient is at target dry weight
* KDOQI defined hypertension (predialysis SBP \>140 or postdialysis SBP\>130) AND
* pre to post hemodialysis SBP increase (\>10 mmHg) during 4/6 last HD session

Exclusion Criteria:

* Patients with active cancer or active wounds
* Patient currently on antibiotics or on IV antibiotics within the last month
* BP unable to be measured by routine mechanisms in the upper extremity
* Life expectancy \< 6 months
* Inability to provide informed consent
* Larger interdialytic weight gain (\>5 kg/treatment on average)

Primary outcomes:
measure: Systolic blood pressure
timeFrame: crossover studies followup 3-16 weeks
Secondary outcomes:
measure: Endothelial cell function
timeFrame: crossover studies with followup of 3-16 weeks
Other outcomes:
Locations:
city: Dallas
country: United States
facility: UT Southwestern
state: Texas
Study officials:
affiliation: UT Southwestern Medical Center
name: Jula K Inrig, MD, MHS
role: PRINCIPAL_INVESTIGATOR
References: