Using Intradialytic Blood Pressure Slopes to Guide Ultrafiltration (IBPS)

The University of Texas System (UT)

Status: Terminated

Conditions: Hypertension; ESRD; Extracellular Fluid Alteration

Treatments: Other: Intradialytic Blood Pressure Slope Based Ultrafiltration

Study type: Interventional

Funder types: Other

Identifiers

NCT03303391

STU 032017-024

Details and patient eligibility

About

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.

Enrollment: 14 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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14 participants in 2 patient groups

Standard Care

No Intervention group

Description:

This arm of subjects will have all aspects of fluid management and dialysis management managed by the his/her individual nephrologist

IBPS Group

Experimental group

Description:

This group will have ultrafiltration prescriptions dictated by a pre-specified protocol that is based on monthly assessment of intradialytic blood pressure slopes obtained over a two week period.

Treatment:

Other: Intradialytic Blood Pressure Slope Based Ultrafiltration