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Mechanisms and Treatment of Intradialytic Hypertension - Sodium

Mechanisms and Treatment of Intradialytic Hypertension - Sodium

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01371890
Acronym
MATCH-Sodium
Enrollment
18
Registered
2011-06-13
Start date
2011-05-31
Completion date
2012-08-31
Last updated
2020-12-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

End-stage Renal Disease, Hemodialysis, Hypertension, Intradialytic Hypertension

Keywords

hemodialysis, end-stage renal disease, hypertension

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.

Interventions

None listed

Sponsors

University of Texas Southwestern Medical Center
Lead SponsorOTHER

Study design

Observational model
CASE_CROSSOVER
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No

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)

Design outcomes

Primary

MeasureTime frameDescription
Systolic blood pressurecrossover studies followup 3-16 weeksDifferences in blood pressure during hemodialysis between treatments

Secondary

MeasureTime frameDescription
Endothelial cell functioncrossover studies with followup of 3-16 weeksDifferences in nitric oxide and endothelin-1 across treatments Differences in FMD and ADMA between treatments

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026