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Completed

NCT Number: NCT01371890

Mechanisms and Treatment of Intradialytic Hypertension - 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.

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Key information

Conditions

Hemodialysis Cardiovascular Diseases Chronic Disease Disease Attributes End-stage Renal Disease Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Hypertension Intradialytic Hypertension Kidney Diseases Kidney Failure, Chronic Male Urogenital Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Urogenital Diseases Urologic Diseases Vascular Diseases

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Observational

Primary location

UT Southwestern

Dallas, Texas, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Primary outcomes

  1. Systolic blood pressure

    Time frame: crossover studies followup 3-16 weeks

    Differences in blood pressure during hemodialysis between treatments

Secondary outcomes

  1. Endothelial cell function

    Time frame: crossover studies with followup of 3-16 weeks

    Differences in nitric oxide and endothelin-1 across treatments Differences in FMD and ADMA between treatments

Sponsors and collaborators

Lead sponsor

University of Texas Southwestern Medical Center

Other

Registry information

Acronym: MATCH-Sodium

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Jun 13, 2011
Registry last updated
Dec 21, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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