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NCT01371890 Clinical Trial

Mechanisms and Treatment of Intradialytic Hypertension - Sodium

Hypertension Clinical Trial

— MATCH-Sodium  

Official title:
Mechanisms and Treatment of Intradialytic Hypertension - Sodium

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01371890
Other study ID # 092018-018
Secondary ID
Status Completed
Phase
First received
Last updated
Start date May 2011
Est. completion date August 2012

Study information
Verified date December 2020
Source University of Texas Southwestern Medical Center
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 18
Est. completion date August 2012
Est. primary completion date August 2012
Accepts healthy volunteers No
Gender All
Age group 18 Years to 85 Years
Eligibility 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

Related Conditions & MeSH terms

Locations
Country Name City State
United States UT Southwestern Dallas Texas

Sponsors (1)
Lead Sponsor Collaborator
University of Texas Southwestern Medical Center

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Systolic blood pressure Differences in blood pressure during hemodialysis between treatments crossover studies followup 3-16 weeks
Secondary 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
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