Mechanisms and Treatment of Intradialytic Hypertension - Sodium (MATCH-Sodium)

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

Study Overview

• Status: Completed
• Conditions: Hypertension; Hemodialysis; End-stage Renal Disease; 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 Type: Observational
• Enrollment (Actual): 18

Contacts and Locations

Study Locations

• United States
  • Texas
    • Dallas, Texas, United States
      • UT Southwestern

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Intradialytic hypertension; Patients with systolic blood pressure increases > 10 mmHg during 4/6 hemodialysis sessions

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Systolic blood pressure	Differences in blood pressure during hemodialysis between treatments	crossover studies followup 3-16 weeks

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: University of Texas Southwestern Medical Center

Study record dates

Study Major Dates

• Study Start: May 1, 2011
• Primary Completion (ACTUAL): August 1, 2012
• Study Completion (ACTUAL): August 1, 2012

Study Registration Dates

• First Submitted: June 9, 2011
• First Submitted That Met QC Criteria: June 10, 2011
• First Posted (ESTIMATE): June 13, 2011

Study Record Updates

• Last Update Posted (ACTUAL): December 21, 2020
• Last Update Submitted That Met QC Criteria: December 17, 2020
• Last Verified: December 1, 2020

More Information

Terms related to this study

• Keywords: hypertension; end-stage renal disease; hemodialysis
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Urologic Diseases; Renal Insufficiency; Renal Insufficiency, Chronic; Hypertension; Kidney Diseases; Kidney Failure, Chronic
• Other Study ID Numbers: 092018-018