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NCT04163614Completed

Blood Pressure Slopes and Ultrafiltration in Hemodialysis Patients

Using Intradialytic Blood Pressure Slopes to Guide Ultrafiltration in Hemodialysis Patients

Source: ClinicalTrials.gov · Last updated 29 Oct 2026

Brief summary (registry, in English)

Kidney failure has been recognized as one of the most costly chronic conditions among United States Veterans. Approximately 13,000 Veterans develop kidney failure each year, and most require hemodialysis initiation. Hemodialysis patients suffer significantly increased risk of death and hospitalizations, and excessive body fluid is a major cause of this. While empiric aggressive fluid removal during dialysis is one approach to limit fluid overload, this can cause dangerous decreases in blood pressure during dialysis that independently contribute to the high death rate. In this study, I aim to test a new strategy that prescribes fluid removal based on a patient's recent blood pressure patterns during dialysis. This clinical trial will compare my strategy to standard care and assess the outcomes of overall blood pressure change between dialysis treatments in addition to the number of times the blood pressure becomes dangerously low during dialysis. Another aim is to determine how differences in the structure and function of the heart influence blood pressure during dialysis.

Status (registry)
Completed
Study type
Interventional
Enrollment
48 (actual)
First submitted
12 Nov 2019
Start date
10 Feb 2021
Primary completion date
1 Oct 2026
Lead sponsor
VA Office of Research and Development
NCT number
NCT04163614

What you commit to

  • Study type: Interventional
  • Participants enrolled: 48
  • From 10 Feb 2021 to the primary completion date, 1 Oct 2026
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Documented antihypertensive medication non-adherence

Other illness

  • For bioimpedance measurements only: amputation of a major extremity, presence of cardiac defibrillator or pacemaker, presence of a metallic implant (prosthetic joint)

Other

  • HemoDialysis Vintage Less than 2 months
  • Pregnancy
  • Mean systolic blood pressure nadir \<95 millimeters of mercury in 2 weeks screening
  • Mean pre- or post-dialysis systolic blood pressure \>180 millimeters of mercury
  • Mean pre to post-HD decrease in blood pressure \>60 millimeters of mercury
  • Routine intradialytic clonidine use
  • Routine intradialytic midodrine use
  • Mean ultrafiltration rate \>13 milliliters per kilogram per hour (mL/kg/hr) during 2 week screening

Who the study is looking for

  • Hemodialysis patient
  • Pre-dialysis systolic blood pressure greater than 140 millimeters of mercury (mmHg) averaged over 2 weeks OR post-dialysis systolic blood pressure greater than 130 millimeters of mercury averaged over 2 weeks

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
VA North Texas Health Care System Dallas VA Medical Center, Dallas, TX
Coordinator of this site? Confirm its status
DallasUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.