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
• Status: Completed
• 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
• 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)

Related Conditions & MeSH terms

• End-stage Renal Disease
• Hemodialysis
• Hypertension
• Intradialytic Hypertension
• Kidney Diseases
• Kidney Failure, Chronic

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