IBPS: Using Intradialytic Blood Pressure Slopes to Guide Ultrafiltration

Sponsor
University of Texas Southwestern Medical Center (Other)
Overall Status
Terminated
CT.gov ID
NCT03303391
Collaborator
(none)
14
1
2
26
0.5

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Other: Intradialytic Blood Pressure Slope Based Ultrafiltration
N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
14 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Using Intradialytic Systolic Blood Pressure Slopes to Guide Ultrafiltration in Hemodialysis Patients: A Validation Study and Clinical Trial
Actual Study Start Date :
Nov 1, 2017
Actual Primary Completion Date :
Jan 1, 2020
Actual Study Completion Date :
Jan 1, 2020

Arms and Interventions

Arm Intervention/Treatment
No Intervention: Standard Care

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

Experimental: IBPS Group

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.

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

Outcome Measures

Primary Outcome Measures

  1. Change in Mean Ambulatory Systolic Blood Pressure [Baseline, 4 months]

    The change in mean systolic ambulatory blood pressure from study baseline to completion (4 months)

Secondary Outcome Measures

  1. Change in Extracellular Volume/Body Weight Ratio [Baseline, 4 months]

    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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 80 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Davita Dialysis Dallas Texas United States 75390

Sponsors and Collaborators

  • University of Texas Southwestern Medical Center

Investigators

  • Principal Investigator: Peter Van Buren, MD, MSCS, University of Texas Southwestern Medical Center

Study Documents (Full-Text)

More Information

Publications

None provided.
Responsible Party:
Peter Van Buren, Assistant Professor, University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier:
NCT03303391
Other Study ID Numbers:
  • STU 032017-024
First Posted:
Oct 6, 2017
Last Update Posted:
Aug 25, 2022
Last Verified:
Mar 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

Participant Flow

Recruitment Details
Pre-assignment Detail
Arm/Group Title Standard Care IBPS Group
Arm/Group Description This arm of subjects will have all aspects of fluid management and dialysis management managed by the his/her individual nephrologist 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. 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
Period Title: Overall Study
STARTED 9 3
COMPLETED 9 3
NOT COMPLETED 0 0

Baseline Characteristics

Arm/Group Title Standard Care IBPS Group Total
Arm/Group Description This arm of subjects will have all aspects of fluid management and dialysis management managed by the his/her individual nephrologist 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. 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 Total of all reporting groups
Overall Participants 9 3 12
Age (Count of Participants)
<=18 years
0
0%
0
0%
0
0%
Between 18 and 65 years
8
88.9%
2
66.7%
10
83.3%
>=65 years
1
11.1%
1
33.3%
2
16.7%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]
53.4
(11)
57.3
(13)
54.6
(11)
Sex: Female, Male (Count of Participants)
Female
3
33.3%
2
66.7%
5
41.7%
Male
6
66.7%
1
33.3%
7
58.3%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino
5
55.6%
1
33.3%
6
50%
Not Hispanic or Latino
4
44.4%
2
66.7%
6
50%
Unknown or Not Reported
0
0%
0
0%
0
0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native
0
0%
0
0%
0
0%
Asian
0
0%
0
0%
0
0%
Native Hawaiian or Other Pacific Islander
0
0%
0
0%
0
0%
Black or African American
4
44.4%
2
66.7%
6
50%
White
5
55.6%
1
33.3%
6
50%
More than one race
0
0%
0
0%
0
0%
Unknown or Not Reported
0
0%
0
0%
0
0%
Region of Enrollment (Count of Participants)
United States
9
100%
3
100%
12
100%
Diabetes (Count of Participants)
Count of Participants [Participants]
6
66.7%
3
100%
9
75%

Outcome Measures

1. Primary Outcome
Title Change in Mean Ambulatory Systolic Blood Pressure
Description The change in mean systolic ambulatory blood pressure from study baseline to completion (4 months)
Time Frame Baseline, 4 months

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group Title Standard Care IBPS Group
Arm/Group Description This arm of subjects will have all aspects of fluid management and dialysis management managed by the his/her individual nephrologist 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. 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
Measure Participants 9 3
Mean (Standard Deviation) [mmHg]
-0.9
(12)
-21.3
(6.7)
2. Secondary Outcome
Title Change in Extracellular Volume/Body Weight Ratio
Description 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
Time Frame Baseline, 4 months

Outcome Measure Data

Analysis Population Description
In the Standard of Care arm/ group, it was not possible to obtain these measurements in 3 subjects (amputations, defibrillators, implanted metal) and are missing the data since they were unable to undergo these measurements.
Arm/Group Title Standard Care IBPS Group
Arm/Group Description This arm of subjects will have all aspects of fluid management and dialysis management managed by the his/her individual nephrologist 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. 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
Measure Participants 6 3
Mean (Standard Deviation) [L/kg]
-0.003
(.02)
-.01
(.007)

Adverse Events

Time Frame Adverse events were determined over a 4 month period per subject
Adverse Event Reporting Description
Arm/Group Title Standard Care IBPS Group
Arm/Group Description This arm of subjects will have all aspects of fluid management and dialysis management managed by the his/her individual nephrologist 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. 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
All Cause Mortality
Standard Care IBPS Group
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total 0/9 (0%) 0/3 (0%)
Serious Adverse Events
Standard Care IBPS Group
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total 0/9 (0%) 0/3 (0%)
Other (Not Including Serious) Adverse Events
Standard Care IBPS Group
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total 5/9 (55.6%) 3/3 (100%)
Blood and lymphatic system disorders
Intradialytic Hypotension 5/9 (55.6%) 10 3/3 (100%) 11

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Results Point of Contact

Name/Title Peter Van Buren
Organization University of Texas Southwestern Medical Center
Phone 214-645-8293
Email peter.vanburen@utsouthwestern.edu
Responsible Party:
Peter Van Buren, Assistant Professor, University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier:
NCT03303391
Other Study ID Numbers:
  • STU 032017-024
First Posted:
Oct 6, 2017
Last Update Posted:
Aug 25, 2022
Last Verified:
Mar 1, 2022