Intradialytic HypotensionNCT02264522
Pilot Study Using a Pulse Oximeter Derived Photo-plethysmographic Waveform to Guide Hemodialysis Ultrafiltration
A study testing Place dialysis chair into position 3., Decrease dialysate temperature. and Decrease ultrafiltration rate by 25%. in people with Intradialytic Hypotension and Hypervolemia, run by Intelomed, Inc. at 1 site in United States.
Trial summary
The purpose of this study is to use the photo-plethysmographic [PPG] waveform signal to guide the dialysis and ultrafiltration [UF] of chronic maintenance hemodialysis patients, and to further the investigators understanding of homeostasis in hemodialysis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intradialytic Hypotension, Hypervolemia
- What is being tested?
- Place dialysis chair into position 3., Decrease dialysate temperature. and Decrease ultrafiltration rate by 25%.
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2014to Aug 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age >18 years
- On dialysis > 6 months with a stable dialysis program
- Consistent achievement of a spKt/V ≥ 1.2
- HGB ≥ 10 gm% ± ESA support
- Consistent failure to achieve a post weight ≤ dry weight + 0.5Kg
- Able to give informed consent directly
Show all 11Show fewer
- Frequent hypotensive reactions (≥ 1 / treatment in 4 of last 8 treatments)
- Symptoms of hypotension
- Intervention administered because of IDH (saline, "turn downs, early termination, trendelenberg position)
- Drop in BP irrespective of symptoms. SBP < 90 mmHG intra or post HD if pre SBP was > 110 mmHG; SBP < 85 mmHG or 15 mmHG drop from start if starting BP ≤ 110 mmHG.
- Or judged by the nursing staff to be difficult to achieve dry weight.
Who cannot join
- Dialysis Catheter Access that may interfere with continuous data collection, per PI determination. (Catheter access is a relative exclusion based on the history of catheter performance.)
- Cognitive Impairment precluding cooperation, and consent
- Restless or unlikely to wear the monitor head-band
- Too unstable in the judgment of their nephrologist to be included in a study of this nature.
Trial locations and contacts
1 site in 1 country.
United States1 site
Centers for Dialysis Care - East
Cleveland, Ohio, 44106
About this study
Official title: Use of Pulse Oximeter Derived Photo-plethysmographic Waveform to Guide Ultrafiltration in Hemodialysis Patients to Achieve Euvolemia While Minimizing Intra-dialytic Hypotension
The purpose of this study is to use the photo-plethysmographic [PPG] waveform signal to guide the dialysis and ultrafiltration [UF] of chronic maintenance hemodialysis patients, and to further the investigators understanding of homeostasis in hemodialysis.
The investigators hypothesize that the signals generated from the PPG device along with traditional monitoring and nursing judgment, will allow experienced, oriented staff to anticipate hemodynamic instability, intervene to prevent or mitigate the intradialytic hypotention [IDH], forestalling the onset of non-facilitating compensatory reflexes that preclude the patient from achieving an appropriate post-dialysis weight consistent with euvolemia. Furthermore, it is hypothesized that the nephrologist and staff will be able to wean patients from anti-hypertensive medications and craft patient specific dialysis orders and UF profiles that achieve consistent, comfortable treatment to appropriate end points.
Read more
The study aims include:
Aim 1: To confirm the temporal sequence of PPG signals and changes in BP in routine hemodialysis.
Aim 2: To refine further the predictive algorithms of PPG, augmented with continuous cardiac event monitoring (pre-intra-post hemodialysis) Aim 3: To develop targeted interventions to reverse the cardiovascular stress indicated by the PPG and to maintain perfusion.
Aim 4: To develop care paths approved by the medical staff and primary care nephrologist allowing RNs to respond to signals from the PPG.
- Conditions
- Intradialytic Hypotension, Hypervolemia
- Being tested
- Place dialysis chair into position 3., Decrease dialysate temperature., Decrease ultrafiltration rate by 25%., Decrease ultrafiltration rate by 50%.
- Medical subject headings
- Edema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Place dialysis chair into position 3.Other
Upon device notification event 1, place patient in dialysis chair position 3.
Decrease dialysate temperature.Other
Upon device notification event 2, decrease dialysate temperature by 0.5 degree centigrade.
Decrease ultrafiltration rate by 25%.Other
Upon device notification event 3, decrease ultrafiltration rate by 25% from baseline ultrafiltration rate.
Decrease ultrafiltration rate by 50%.Other
Upon device notification event 4, decrease ultrafiltration rate by 50% from baseline ultrafiltration rate.
| Study group | Role | What they receive |
|---|---|---|
| Single Arm | Experimental | All patients will be enrolled in the same intervention arm. Interventions are implemented based in 1-4 event levels on the device. Interventions include: "Place dialysis chair into position 3", "Decrease dialysate temperature", "Decrease ultrafiltration rate by 25%", and "Decrease ultrafiltration rate by 50%". Receives: Other: Place dialysis chair into position 3.; Other: Decrease dialysate temperature.; Other: Decrease ultrafiltration rate by 25%.; Other: Decrease ultrafiltration rate by 50%. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference between prescribed dry weight and actual measured weight at end of dialysis session.
Percent difference between prescribed dry weight and actual weight at end of dialysis session.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2014 (estimated)
- Study startSep 2014
- Primary completionAug 2015
- Study completionAug 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intradialytic HypotensionStudies 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
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Intelomed, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Centers for Dialysis Care, Inc
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02264522
- Sponsor's protocol ID
- 04-14-39
- Status last verified
- Aug 2016
- First submitted
- 22 Sep 2014
- Last updated
- 30 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Pulse Oximeter Derived Photo-plethysmographic Waveform to Guide Ultrafiltration in Hemodialysis Patients to Achieve Euvolemia While Minimizing Intra-dialytic Hypotension
- ClinicalTrials.gov ID
- NCT02264522
- Acronym / sponsor ID
- 04-14-39
- Conditions
- Intradialytic Hypotension, Hypervolemia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Intelomed, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Centers for Dialysis Care, Inc
- Study start
- Sep 2014
- Primary completion
- Aug 2015 (actual)
- Study completion
- Aug 2015 (actual)
- First posted
- 15 Oct 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to use the photo-plethysmographic [PPG] waveform signal to guide the dialysis and ultrafiltration [UF] of chronic maintenance hemodialysis patients, and to further the investigators understanding of homeostasis in hemodialysis.
The investigators hypothesize that the signals generated from the PPG device along with traditional monitoring and nursing judgment, will allow experienced, oriented staff to anticipate hemodynamic instability, intervene to prevent or mitigate the intradialytic hypotention [IDH], forestalling the onset of non-facilitating compensatory reflexes that preclude the patient from achieving an appropriate post-dialysis weight consistent with euvolemia. Furthermore, it is hypothesized that the nephrologist and staff will be able to wean patients from anti-hypertensive medications and craft patient specific dialysis orders and UF profiles that achieve consistent, comfortable treatment to appropriate end points.
The study aims include:
Aim 1: To confirm the temporal sequence of PPG signals and changes in BP in routine hemodialysis.
Aim 2: To refine further the predictive algorithms of PPG, augmented with continuous cardiac event monitoring (pre-intra-post hemodialysis) Aim 3: To develop targeted interventions to reverse the cardiovascular stress indicated by the PPG and to maintain perfusion.
Aim 4: To develop care paths approved by the medical staff and primary care nephrologist allowing RNs to respond to signals from the PPG.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single Arm | Experimental | Other: Place dialysis chair into position 3., Other: Decrease dialysate temperature., Other: Decrease ultrafiltration rate by 25%., Other: Decrease ultrafiltration rate by 50%.All patients will be enrolled in the same intervention arm. Interventions are implemented based in 1-4 event levels on the device. Interventions include: "Place dialysis chair into position 3", "Decrease dialysate temperature", "Decrease ultrafiltration rate by 25%", and "Decrease ultrafiltration rate by 50%". |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Age >18 years
- On dialysis > 6 months with a stable dialysis program
- Consistent achievement of a spKt/V ≥ 1.2
- HGB ≥ 10 gm% ± ESA support
- Consistent failure to achieve a post weight ≤ dry weight + 0.5Kg
Key exclusion criteria (4 listed)
- Dialysis Catheter Access that may interfere with continuous data collection, per PI determination. (Catheter access is a relative exclusion based on the history of catheter performance.)
- Cognitive Impairment precluding cooperation, and consent
- Restless or unlikely to wear the monitor head-band
- Too unstable in the judgment of their nephrologist to be included in a study of this nature.
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 |
|---|---|---|
| Place dialysis chair into position 3.Upon device notification event 1, place patient in dialysis chair position 3. | Other | Single Arm |
| Decrease dialysate temperature.Upon device notification event 2, decrease dialysate temperature by 0.5 degree centigrade. | Other | Single Arm |
| Decrease ultrafiltration rate by 25%.Upon device notification event 3, decrease ultrafiltration rate by 25% from baseline ultrafiltration rate. | Other | Single Arm |
| Decrease ultrafiltration rate by 50%.Upon device notification event 4, decrease ultrafiltration rate by 50% from baseline ultrafiltration rate. | Other | Single Arm |
Primary outcome
Difference between prescribed dry weight and actual measured weight at end of dialysis session.
Time frame: 8 weeks
Percent difference between prescribed dry weight and actual weight at end of dialysis session.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Aug 2016.
- Individual participant dataSharing planned: No
Related trials for Intradialytic Hypotension
Active, not recruitingPhase 3
Prevention of Intradialytic Hypotension by Inhibiting Bradykinin B2 Receptor
Intradialytic Hypotension
Recruiting
Trial of Variable Dialysate Bicarbonate
Peri-dialytic Cardiac Rhythms, Intradialytic Hypotension
Recruiting
Blood Pressure Slopes and Ultrafiltration in Hemodialysis Patients
End Stage Renal Disease, Hypertension
Recruiting
Improved Hemodynamic Tolerance of Intermittent Hemodialysis Sessions in Intensive Care Unite Using Citrate- vs Acetate-based Dialysate
Intradialytic Hypotension
Recruiting
Using a Hypotension Prediction Index to Prevent Low Blood Pressure During Dialysis in ICU Patients
Intradialytic Hypotension, Intensive Care Unit ICU
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Place dialysis chair into position 3., Decrease dialysate temperature. and Decrease ultrafiltration rate by 25%. in people with Intradialytic Hypotension and Hypervolemia, run by Intelomed, Inc. at 1 site in United States.
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 11 inclusion and 4 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: finished, as of the sponsor's last update on 30 Aug 2016. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Difference between prescribed dry weight and actual measured weight at end of dialysis session. (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 30 Aug 2016.