TerminatedNot Applicable

Using Intradialytic Blood Pressure Slopes to Guide Ultrafiltration

Stopped: Funding Expired

United States14 participantsStarted 2017-11-01

Plain-language summary

This study is an open label randomized clinical trial that comparing intradialytic blood pressure slope-based ultrafiltration prescriptions to standard care in the chronic fluid management of maintenance hemodialysis patients. It also includes a cross sectional component evaluating the associations between intradialytic blood pressure slopes ascertained over 2 week periods with measurements of extracellular water/body weight obtained with multifrequency bioimpedance spectroscopy.

Who can participate

Age range

18 Years – 80 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Age greater than 18 years * End Stage Renal Disease on Maintenance Hemodialysis * Hypertension defined as systolic blood pressure \> 140 mmHg pre-dialysis or \>130 mmHg post dialysis Exclusion Criteria: * Hemodialysis Vintage \< 1 month * Pregnancy * Nadir Systolic Blood Pressure \< 95 mmHg * Pre or Post dialysis systolic blood pressure \> 180 mmHg * Decrease in systolic blood pressure \>60 mmHg from pre to post dialysis * Ultrafiltration rate \>13 mL/kg/hr * Peridialytic Midodrine Use * Intradialytic Clonidine use * Documented Antihypertensive Medication Non-adherence Bioimpedance will not be peformed on patients with * amputated arms or legs * cardiac defibrillator or pacemaker * presence of metal prostheses

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change in Mean Ambulatory Systolic Blood Pressure

Timeframe: Baseline, 4 months

Trial details

NCT IDNCT03303391

SponsorUniversity of Texas Southwestern Medical Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2020-01-01

Results submitted2021-12-21

View on ClinicalTrials.gov More ESRD trials