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Blood Pressure Slopes and Ultrafiltration in Hemodialysis Patients

Using Intradialytic Blood Pressure Slopes to Guide Ultrafiltration in Hemodialysis Patients

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests a new way to decide how much fluid to remove during hemodialysis, a treatment that cleans the blood when kidneys fail. It is for people on hemodialysis who have high blood pressure before or after treatment. The study compares the new plan with usual care, checks blood pressure changes and dangerously low readings, and looks at how the heart affects blood pressure.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • You receive hemodialysis.
  • Over 2 weeks, your average systolic blood pressure (the top number) is above 140 mmHg before dialysis OR above 130 mmHg after dialysis.

Who can't join

  • You have been on hemodialysis for less than 2 months.
  • You are pregnant.
  • During the 2-week screening, your lowest top-number blood pressure readings during dialysis average below 95 mmHg.
  • Your average top-number blood pressure is above 180 mmHg before or after dialysis, or it drops by more than 60 mmHg on average from before to after treatment.
  • You regularly take clonidine or midodrine during dialysis.
  • Your records show that you have not taken blood pressure medicine as directed.
  • During the 2-week screening, your average fluid removal rate is above 13 milliliters per kilogram of body weight per hour.
  • For body fluid measurements using a small electrical signal only: you have a major limb amputation, a heart defibrillator or pacemaker, or a metal implant such as an artificial joint.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion Criteria: * Hemodialysis patient * Pre-dialysis systolic blood pressure greater than 140 mmHg averaged over 2 weeks OR post-dialysis systolic blood pressure greater than 130 mmHg averaged over 2 weeks Exclusion Criteria: * HemoDialysis Vintage Less than 2 months * Pregnancy * Mean systolic blood pressure nadir \<95 mmHg in 2 weeks screening * Mean pre- or post-dialysis systolic blood pressure \>180 mmHg * Mean pre to post-HD decrease in blood pressure \>60 mmHg * Routine intradialytic clonidine use * Routine intradialytic midodrine use * Documented antihypertensive medication non-adherence * Mean ultrafiltration rate \>13 mL/kg/hr during 2 week screening * For bioimpedance measurements only: amputation of a major extremity, presence of cardiac defibrillator or pacemaker, presence of a metallic implant (prosthetic joint)

Study sites (1)

TX