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

This study is currently recruiting participants.
Verified August 2012 by University of Texas Southwestern Medical Center
Sponsor:
Information provided by (Responsible Party):
Jula K Inrig, University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier:
NCT01371890
First received: June 9, 2011
Last updated: August 15, 2012
Last verified: August 2012
History of Changes
  Purpose

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


Condition
Hemodialysis
End-stage Renal Disease
Hypertension
Intradialytic Hypertension

Study Type: Observational
Study Design: Observational Model: Case-Crossover
Time Perspective: Prospective
Official Title: Mechanisms and Treatment of Intradialytic Hypertension - Sodium

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Texas Southwestern Medical Center:

Primary Outcome Measures:
  • Systolic blood pressure [ Time Frame: crossover studies followup 3-16 weeks ] [ Designated as safety issue: No ]
    Differences in blood pressure during hemodialysis between treatments


Secondary Outcome Measures:
  • Endothelial cell function [ Time Frame: crossover studies with followup of 3-16 weeks ] [ Designated as safety issue: No ]
    Differences in nitric oxide and endothelin-1 across treatments Differences in FMD and ADMA between treatments


Biospecimen Retention:   Samples Without DNA

Samples stored for nitric oxide and endothelin-1 measurements


Estimated Enrollment: 45
Study Start Date: May 2011
Groups/Cohorts
Intradialytic hypertension
Patients with systolic blood pressure increases > 10 mmHg during 4/6 hemodialysis sessions

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.

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

Criteria

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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01371890

Locations
United States, Texas
UT Southwestern DaVita Recruiting
Dallas and Irving, Texas, United States
Contact: Jula Inrig, MD, MHS     214-645-8263        
Sponsors and Collaborators
University of Texas Southwestern Medical Center
Investigators
Principal Investigator: Jula K Inrig, MD, MHS UT Southwestern Medical Center
  More Information

No publications provided

Responsible Party: Jula K Inrig, Assistant Professor of Medicine, University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier: NCT01371890     History of Changes
Other Study ID Numbers: 092018-018
Study First Received: June 9, 2011
Last Updated: August 15, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by University of Texas Southwestern Medical Center:
hemodialysis
end-stage renal disease
hypertension

Additional relevant MeSH terms:
Hypertension
Kidney Diseases
Kidney Failure, Chronic
Vascular Diseases
 Cardiovascular Diseases
Urologic Diseases
Renal Insufficiency, Chronic
Renal Insufficiency

ClinicalTrials.gov processed this record on June 18, 2013