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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT03303391
Other study ID # STU 032017-024
Secondary ID
Status Terminated
Phase N/A
First received
Last updated
Start date November 1, 2017
Est. completion date January 1, 2020

Study information

Verified date March 2022
Source University of Texas Southwestern Medical Center
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Terminated
Enrollment 14
Est. completion date January 1, 2020
Est. primary completion date January 1, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years to 80 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Intradialytic Blood Pressure Slope Based Ultrafiltration
Algorithmic Determination of ultrafiltration based on intradialytic blood pressure slopes calculated at the beginning of each month from the prior two weeks of dialysis treatments

Locations

Country Name City State
United States Davita Dialysis Dallas Texas

Sponsors (1)

Lead Sponsor Collaborator
University of Texas Southwestern Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in Mean Ambulatory Systolic Blood Pressure The change in mean systolic ambulatory blood pressure from study baseline to completion (4 months) Baseline, 4 months
Secondary Change in Extracellular Volume/Body Weight Ratio expected reduction of at least 0.025 greater reduction for IBPS compared to standard care The change in ECV/body weight from baseline to 4 month Baseline, 4 months
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