Hypertension Clinical Trial
Official title:
Using Intradialytic Blood Pressure Slopes to Guide Ultrafiltration in Hemodialysis Patients
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 | Recruiting |
Enrollment | 69 |
Est. completion date | July 1, 2025 |
Est. primary completion date | July 1, 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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) |
Country | Name | City | State |
---|---|---|---|
United States | VA North Texas Health Care System Dallas VA Medical Center, Dallas, TX | Dallas | Texas |
Lead Sponsor | Collaborator |
---|---|
VA Office of Research and Development |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Ambulatory Systolic Blood Pressure | Will compare between-group difference in change in ambulatory systolic blood pressure from baseline to 4-month follow up | 4 months | |
Secondary | Extracellular Volume | Will compare the between-group difference in change in post-dialysis extracellular water/body weight measured with multifrequency bioimpedance spectroscopy. | 4 months | |
Secondary | Total Peripheral Resistance Index | Will compare the between-group difference in change in post-dialysis total peripheral resistance index measured with a non-invasive cardiac output monitor. | 4 months | |
Secondary | Intradialytic Hypotension | The investigators will compare the between-group difference in the occurrence of intradialytic systolic blood pressure nadir less than 90 and 95 mmHg. | 4 months | |
Secondary | Association Between intradialytic blood pressure slope with systolic and diastolic dysfunction | The investigators will analyze the correlation between intradialytic blood pressure slopes with both ejection fraction and mitral inflow/mitral annuls velocities measured with transthoracic echocardiograms | 3 days |
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