Mechanisms and Treatment of Intradialytic Hypertension -... | NCT01371890

Studies
Mechanisms and Treatment of Intradialytic Hypertension - Sodium

NCT01371890

Sponsor

University of Texas Southwestern Medical Center

Status

Completed

Last Update Posted

Dec 21, 2020Actual

Enrollment

18Actual

Phase

Not provided

Conditions

Hemodialysis
End-stage Renal Disease
Hypertension
Intradialytic Hypertension

Interventions

Not provided

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2020

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2011

Primary Completion Date

Aug 2012Actual

Completion Date

Aug 2012Actual

First Submitted Date

Jun 9, 2011

First Submission Date that Met QC Criteria

Jun 10, 2011

First Posted Date

Jun 13, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 17, 2020

Last Update Posted Date

Dec 21, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

18Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Intradialytic hypertension		Patients with systolic blood pressure increases > 10 mmHg during 4/6 hemodialysis sessions

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Systolic blood pressure	Differences in blood pressure during hemodialysis between treatments	crossover studies followup 3-16 weeks

Secondary Outcomes

Measure	Description	Time Frame
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

Other Outcomes

Not provided

Eligibility Module

Eligibility 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)

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

85 Years

Standard Ages

AdultOlder Adult

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.

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Jula K Inrig, MD, MHS	University of Texas Southwestern Medical Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
UT Southwestern		Dallas	Texas		United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
39498822	Derived	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.

ID	Term
D007676	Kidney Failure, Chronic
D006973	Hypertension

ID	Term
D051436	Renal Insufficiency, Chronic
D051437	Renal Insufficiency
D007674	Kidney Diseases
D014570	Urologic Diseases