ESRDIBPSNCT03303391

Using Intradialytic Blood Pressure Slopes to Guide Ultrafiltration

A study testing Intradialytic Blood Pressure Slope Based Ultrafiltration in people with ESRD and Extracellular Fluid Alteration, run by University of Texas Southwestern Medical Center at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

Who is it for?: Ages 18 to 80 years
Conditions the study is for: ESRD, Extracellular Fluid Alteration, Hypertension
What is being tested?: Intradialytic Blood Pressure Slope Based Ultrafiltration
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 14 participants
Where: 1 siteUnited States
Study dates: 1 Nov 2017to 1 Jan 2020
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 80 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

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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 locations and contacts

1 site in 1 country.

United States1 site

Davita Dialysis
Dallas, Texas, 75390

Other trials in United States

About this study

Official title: Using Intradialytic Systolic Blood Pressure Slopes to Guide Ultrafiltration in Hemodialysis Patients: A Validation Study and Clinical Trial

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.

Conditions: ESRD, Extracellular Fluid Alteration, Hypertension
Being tested: Intradialytic Blood Pressure Slope Based Ultrafiltration
Medical subject headings: Kidney Failure, Chronic, Hypertension

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Intradialytic Blood Pressure Slope Based UltrafiltrationOther
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

Study groups in NCT03303391
Study group	Role	What they receive
Standard Care	No intervention	This arm of subjects will have all aspects of fluid management and dialysis management managed by the his/her individual nephrologist
IBPS Group	Experimental	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. Receives: Other: Intradialytic Blood Pressure Slope Based Ultrafiltration

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in Mean Ambulatory Systolic Blood Pressure
The change in mean systolic ambulatory blood pressure from study baseline to completion (4 months)
Measured: Baseline, 4 months

Secondary outcomes (1)

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
Measured: Baseline, 4 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Nov 20171 Jan 2020

First posted6 Oct 2017
Study start1 Nov 2017
Primary completion1 Jan 2020
Study completion1 Jan 2020

Why it stopped: Funding Expired

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for ESRDStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 14 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03303391
Sponsor's protocol ID: STU 032017-024
Acronym: IBPS
Status last verified: Mar 2022
First submitted: 2 Oct 2017
Last updated: 25 Aug 2022
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 25 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Using Intradialytic Systolic Blood Pressure Slopes to Guide Ultrafiltration in Hemodialysis Patients: A Validation Study and Clinical Trial
ClinicalTrials.gov ID: NCT03303391
Acronym / sponsor ID: IBPS / STU 032017-024
Conditions: ESRD, Extracellular Fluid Alteration, Hypertension
Study type: Interventional
Recruitment status: TerminatedReason stopped: Funding Expired
Enrolment: 14 participants (actual)
Lead sponsor: University of Texas Southwestern Medical CenterUniversity, hospital or other
Study start: 1 Nov 2017 (actual)
Primary completion: 1 Jan 2020 (actual)
Study completion: 1 Jan 2020 (actual)
First posted: 6 Oct 2017 (actual)
Results: Posted 25 Aug 2022

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Standard Care	No intervention	–This arm of subjects will have all aspects of fluid management and dialysis management managed by the his/her individual nephrologist
IBPS Group	Experimental	Other: Intradialytic Blood Pressure Slope Based UltrafiltrationThis 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.

Who may qualify

Ages: 18 to 80 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

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

Key exclusion criteria (13 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Intradialytic Blood Pressure Slope Based UltrafiltrationAlgorithmic Determination of ultrafiltration based on intradialytic blood pressure slopes calculated at the beginning of each month from the prior two weeks of dialysis treatments	Other	IBPS Group

Primary outcome

Change in Mean Ambulatory Systolic Blood Pressure
Time frame: Baseline, 4 months
The change in mean systolic ambulatory blood pressure from study baseline to completion (4 months)

1 secondary outcome

Change in Extracellular Volume/Body Weight Ratio
Time frame: Baseline, 4 months

Results and safety

Results posted to the registry on 25 Aug 2022, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Standard Care	9	9
IBPS Group	3	3

Primary outcome: Change in Mean Ambulatory Systolic Blood Pressure

Time frame: Baseline, 4 months. Mean (Standard Deviation). Unit: mmHg

Measure	Standard Care n = 9	IBPS Group n = 3
Value	-0.9 (12)	-21.3 (6.7)

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Adverse events were determined over a 4 month period per subject. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Standard Care	0 of 9 (0%)	5 of 9 (55.6%)	0 of 9
IBPS Group	0 of 3 (0%)	3 of 3 (100%)	0 of 3

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2022.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Peter Van Buren, MD, MSCS principal investigator

University of Texas Southwestern Medical Center

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 25 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 25 Aug 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Mean Ambulatory Systolic Blood Pressure (time frame: Baseline, 4 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03303391.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Aug 2022.