Mechanisms and Treatment of Intradialytic Hypertension

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

18 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-05-31

Study Completion Date

2012-08-31

Brief Summary

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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

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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.

Conditions

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Hemodialysis End-stage Renal Disease Hypertension Intradialytic Hypertension

Keywords

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hemodialysis end-stage renal disease hypertension

Study Design

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Observational Model Type

CASE_CROSSOVER

Study Time Perspective

PROSPECTIVE

Study Groups

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Intradialytic hypertension

Patients with systolic blood pressure increases \> 10 mmHg during 4/6 hemodialysis sessions

No interventions assigned to this group

Eligibility Criteria

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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)

Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jula K Inrig, MD, MHS

Role: PRINCIPAL_INVESTIGATOR

UT Southwestern Medical Center

Locations

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UT Southwestern

Dallas, Texas, United States

Site Status

Countries

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United States

References

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Marshall MR, Wang MY, Vandal AC, Dunlop JL. Low dialysate sodium levels for chronic haemodialysis. Cochrane Database Syst Rev. 2024 Nov 5;11(11):CD011204. doi: 10.1002/14651858.CD011204.pub3.

Reference Type DERIVED

PMID: 39498822 (View on PubMed)

Other Identifiers

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092018-018

Identifier Type: -

Identifier Source: org_study_id

Mechanisms and Treatment of Intradialytic Hypertension - Sodium