Mechanisms and Treatment of Intradialytic Hypertension - Sodium

Completed

• Conditions: Hypertension; Intradialytic Hypertension; End-stage Renal Disease; Hemodialysis

• Registration Number: NCT01371890
• Lead Sponsor: University of Texas Southwestern Medical Center

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.

Study Timeline

• Study Start: 2011-05
• Study First Submitted: 2011-06-09
• Study First Submitted QC: 2011-06-10
• Study First Posted: 2011-06-13
• Primary Completion: 2012-08
• Study Completion: 2012-08
• Status Verified: 2020-12
• Last Update Submitted: 2020-12-17
• Last Update Posted: 2020-12-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 18

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)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Systolic blood pressure	crossover studies followup 3-16 weeks	Differences in blood pressure during hemodialysis between treatments

Secondary Outcome Measures

Name	Time	Method
Endothelial cell function	crossover studies with followup of 3-16 weeks	Differences in nitric oxide and endothelin-1 across treatments Differences in FMD and ADMA between treatments

Trial Locations

Locations (1)

UT Southwestern; 🇺🇸 Dallas, Texas, United States