Mechanisms and Treatment of Intradialytic Hypertension - Sodium

NCT01371890 | Completed

• 1 other identifier: 092018-018
• Study Type: observational
• Target: 18
• Locations: 1 country
• Sites: 1

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.

Conditions

Hemodialysis; End-stage Renal Disease; Hypertension; Intradialytic Hypertension

Keywords

hemodialysis; end-stage renal disease; hypertension

Outcome Measures

Primary Outcomes (1)

• Systolic blood pressure

  Differences in blood pressure during hemodialysis between treatments

  crossover studies followup 3-16 weeks

Secondary Outcomes (1)

• Endothelial cell function

  crossover studies with followup of 3-16 weeks

Study Arms (1)

Intradialytic hypertension

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

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Texas Southwestern Medical Center: lead

Study Sites (1)

UT Southwestern

Dallas, Texas, United States

Location

Related Publications (1)

• 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.

  PMID: 39498822 DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

Samples stored for nitric oxide and endothelin-1 measurements

MeSH Terms

Conditions

Kidney Failure, Chronic; Hypertension

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Jula K Inrig, MD, MHS

  University of Texas Southwestern Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CROSSOVER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 9, 2011
• First Posted: June 13, 2011
• Study Start: May 1, 2011
• Primary Completion: August 1, 2012
• Study Completion: August 1, 2012
• Last Updated: December 21, 2020

Record last verified: 2020-12

Locations

US (1)