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High blood pressureKidney disease

Blood Pressure Slopes and Ultrafiltration in Hemodialysis Patients

Recruiting · Dallas, Texas

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Most need no insurance or papers

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Interpreters available

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Your choice

Voluntary — you can stop anytime

What is this study?

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.

It is , overseen by an independent and licensed medical staff.

Read the full clinical description

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.

Who this study is looking for

In plain language, from the study's own rules. The study team confirms the full details with you — this isn't a final yes or no.

✅ You may be able to join if…

  • You are on hemodialysis (kidney dialysis).
  • Your blood pressure before dialysis averages above 140 mmHg over 2 weeks OR your blood pressure after dialysis averages above 130 mmHg over 2 weeks.
  • You have been on hemodialysis for at least 2 months.
  • Your blood pressure does not drop too low during the 2-week screening period.
  • Your fluid removal rate during the 2-week screening is not too high (mean ultrafiltration rate is 13 mL/kg/hr or less).

🚫 You may not be able to join if…

  • You have been on hemodialysis for less than 2 months.
  • You are pregnant.
  • Your mean systolic blood pressure lowest point (nadir) is under 95 mmHg during the 2-week screening.
  • Your mean pre- or post-dialysis systolic blood pressure is higher than 180 mmHg.
  • Your mean decrease in blood pressure from before to after hemodialysis is greater than 60 mmHg, or you use routine intradialytic clonidine or routine intradialytic midodrine.
  • You have documented antihypertensive medication non-adherence.
  • You have mean ultrafiltration rate greater than 13 mL/kg/hr during the 2-week screening.
  • For the bioimpedance measurements: you have a major limb amputation, a pacemaker/defibrillator, or a metallic implant (like a prosthetic joint).

Are you a good fit?

Simplified highlights. The study team always confirms the full details with you.

  • Adults roughly 18–any age
  • !Not for people who are pregnant or breastfeeding

What to expect, step by step

  1. 1

    Usually a few weeks

    The study team checks whether the study is a good fit for you, with a visit and sometimes lab tests. You can ask any questions before deciding.

  2. 2

    Treatment

    If you join and choose to continue, you receive the study treatment and are watched closely by medical staff.

  3. 3

    Follow-up

    After treatment, the team checks on your health and confirms the visit schedule with you. You can leave the study at any point.

Has this treatment been tested before?

The study team can share what safety testing has been done so far.

What you need to know before you apply

What is this study testing?+

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.

Is it safe? Who makes sure of that?+

This is a research study. Every study is reviewed and monitored by an independent ethics board (called an IRB) whose job is to protect participants, and care is overseen by licensed medical staff. You'll be told the known risks before you agree to anything, and you can stop at any time.

Will I get a placebo instead of the real treatment?+

Some studies compare a treatment against a placebo (an inactive version), and some don't. If this one does, the study team will explain your chances of receiving the active treatment before you decide. Nothing is hidden from you.

Do I have to stop taking my current medications?+

It depends on the study. Some let you stay on your current medications and some ask you to adjust them. Never stop a medication on your own — the study team will review everything with you first.

Does it cost anything? Will I be paid?+

Study-related care is provided at no cost to you. Some studies also pay for your time; the coordinator can tell you if this one does. You should never be asked to pay to take part.

Do I need insurance? Will anyone ask about my immigration status?+

No. You do not need health insurance to take part in a research study, and you will not be asked about your immigration status to join. Taking part is about whether you're a medical fit for the study.

What if English isn't my first language?+

You have the right to understand everything before you agree. Study sites can often provide materials or an interpreter in your language — you can ask the coordinator for one.

Is my information private?+

Yes. Your health information is only shared with the study sites you choose to be contacted by, and only to help match and enroll you. It is never sold, and you can ask us to delete it at any time.

Source: ClinicalTrials.gov · NCT04163614 · Locations: Texas