RECRUITING

Blood Pressure Slopes and Ultrafiltration in Hemodialysis Patients

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

Using Intradialytic Blood Pressure Slopes to Guide Ultrafiltration in Hemodialysis Patients

Quick Facts

Study Start:2021-02-10
Study Completion:2025-07-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04163614

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Hemodialysis patient
  2. * 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
  1. * HemoDialysis Vintage Less than 2 months
  2. * Pregnancy
  3. * Mean systolic blood pressure nadir \<95 mmHg in 2 weeks screening
  4. * Mean pre- or post-dialysis systolic blood pressure \>180 mmHg
  5. * Mean pre to post-HD decrease in blood pressure \>60 mmHg
  6. * Routine intradialytic clonidine use
  7. * Routine intradialytic midodrine use
  8. * Documented antihypertensive medication non-adherence
  9. * Mean ultrafiltration rate \>13 mL/kg/hr during 2 week screening
  10. * For bioimpedance measurements only: amputation of a major extremity, presence of cardiac defibrillator or pacemaker, presence of a metallic implant (prosthetic joint)

Contacts and Locations

Study Contact

Peter N Van Buren, MD
CONTACT
(214) 857-2214
peter.vanburen@va.gov

Principal Investigator

Peter Noel Van Buren, MD
PRINCIPAL_INVESTIGATOR
VA North Texas Health Care System Dallas VA Medical Center, Dallas, TX

Study Locations (Sites)

VA North Texas Health Care System Dallas VA Medical Center, Dallas, TX
Dallas, Texas, 75216-7167
United States

Collaborators and Investigators

Sponsor: VA Office of Research and Development

  • Peter Noel Van Buren, MD, PRINCIPAL_INVESTIGATOR, VA North Texas Health Care System Dallas VA Medical Center, Dallas, TX

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-02-10
Study Completion Date2025-07-01

Study Record Updates

Study Start Date2021-02-10
Study Completion Date2025-07-01

Terms related to this study

Keywords Provided by Researchers

  • End Stage Renal Disease
  • Hypertension
  • Extracellular Volume
  • Intradialytic Hypotension
  • Bioimpedance Spectroscopy

Additional Relevant MeSH Terms

  • End Stage Renal Disease
  • Hypertension
  • Extracellular Volume Overload
  • Intradialytic Hypotension