Blood Pressure Slopes and Ultrafiltration in Hemodialysis Patients

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorVA Office of Research and Development

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • IBPS-Guided Ultrafiltration

    Other intervention

    Each month, the study investigator will review the average intradialytic blood pressure slope from the prior two weeks. A prespecified algorithm will be used to prescribe additional fluid removal/weight reduction based on this slope.

Treatment groups

69 Participants
are divided into 2 treatment groups
Group A: ControlNo intervention 0 interventions
Group B: IBPS (Intradialytic Blood Pressure Slope) ArmExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Ambulatory Systolic Blood Pressure

Will compare between-group difference in change in ambulatory systolic blood pressure from baseline to 4-month follow up

Time frame
4 months

Secondary outcomes

1

Extracellular Volume

Will compare the between-group difference in change in post-dialysis extracellular water/body weight measured with multifrequency bioimpedance spectroscopy.

Time frame
4 months
2

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.

Time frame
4 months
3

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.

Time frame
4 months
4

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

Time frame
3 days

Other outcomes

Sponsors and contacts

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