Hypotension of HemodialysisNCT02182089
Measuring Cardiovascular Stress in Patients on Hemodialysis Study II
An observational study of Hypotension of Hemodialysis and Hypotension, run by Intelomed, Inc. at 1 site in United States.
Trial summary
The overall goal is to evaluate the predictive accuracy of a measure of autoregulatory adequacy derived from CVInsight and compare it with other measures in recognizing hypotensive events during hemodialysis.. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Hypotension of Hemodialysis, Hypotension, Estimated Dry Weight
- How many people
- 48 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2014to 1 Mar 2023
- Phase
- Observational
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Study Population: The sample will be enriched for subjects prone to IDH, defined as patients who experience IDH for greater than 20% of HD treatments in the past 2 months. The study population will consist of 48 patients total, 75% of patients (n=36) prone to IDH and 25% of patients with less than 10% of IDH during the last two months (n=12).
Who may be able to join
- Eligibility shall consist of the following:
- Age ≥ 20 years old
- Speaks and understands English, Spanish or Chinese
- Provides Informed Consent
- Patients with 20% intradialytic hypotensive events over the last two months.
Who cannot join
- Unstable hemodialysis patients per judgment of the clinician prior to the start of the treatment
- Patients unable to have blood pressure cuff measured on the upper arm
- Inability to wear monitor on forehead
- Patients treated with sodium or ultrafiltration profiling and the patient's nephrologist is unwilling to alter this for the study treatments
- Patients unwilling to shave the anterior chest
- Patients with active infection of the upper chest wall tissue.
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- Patients with a deep brain stimulator, as it may disrupt the quality of the ECG data.
- Patients who are unwilling to take short showers versus bathing during the 7 day period .
- Patients who require intradialytic testing (ie transonic) during the monitored treatment.
Trial locations and contacts
1 site in 1 country.
About this study
The overall goal is to evaluate the predictive accuracy of a measure of autoregulatory adequacy derived from CVInsight and compare it with other measures in recognizing hypotensive events during hemodialysis..
Read the detailed description
Specific Aims are as follows:
- Assess the accuracy of a new rule set for CVInsight® in predicting intradialytic hypotensive episodes.
- Assess the comparative predictive accuracy of CVInsight® to other measures with regard to intradialytic hypotensive events.
- Assess estimated dry weight goals by monitoring post-dialytic vascular refill using CVInsight® and other measures.
- Assess hemodialysis(HD)-induced myocardial injury by monitoring the occurrence and frequency of arrhythmias and the levels of cardiac Troponin T.
- Conditions
- Hypotension of Hemodialysis, Hypotension, Estimated Dry Weight, Myocardial Injury, Arrhythmia
- Medical subject headings
- Hypotension, Arrhythmias, Cardiac
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Dialysis patients with greater than 20% IDH | Study Population: The sample will be enriched for subjects prone to IDH, defined as patients who experience IDH for greater than 20% of HD treatments in the past 2 months. The study population will consist of 48 patients total, 75% of patients (n=36) prone to IDH and 25% of patients with less than 10% of IDH during the last two months (n=12). | |
| Patients with less than 10% IDH | Study Population: The sample will be enriched for subjects prone to IDH, defined as patients who experience IDH for greater than 20% of HD treatments in the past 2 months. The study population will consist of 48 patients total, 75% of patients (n=36) prone to IDH and 25% of patients with less than 10% of IDH during the last two months (n=12). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of intradialytic hypotensive (IDH) episodes that can be detected by the new rule set for CVInsight.
IDH defined by at least one of the following: 1) Symptoms of hypotension: dizziness, cramping, altered consciousness, nausea +/- vomiting (new since beginning of session), chest pain, shortness of breath, seizure, diaphoretic. 2) Intervention administered due to IDH; relevant interventions:a) a reduction in ultrafiltration (UF) goal programmed at start of treatment (tx); b) admin. of IV fluid, e.g. saline, mannitol or hypertonic saline; c) stopping tx early due to IDH symptoms or event. 3) A significant drop in blood pressure, regardless of symptoms, defined as:
- For pts w/ a pre-dialysis systolic blood pressure (SBP) >110 mm Hg, an intra or post-dialysis SBP <90 mm Hg, or a drop of >40 mm Hg over 30 min.
- For pts w/ a pre-dialysis SBP <110, a decline in SBP <85 mm Hg or 15 mm Hg or lower than their starting BP.
Measured: 3-4 hours, for two hemodialysis session, or 6-8 hours total
Secondary outcomes (3)
The comparative, predictive accuracy of CVInsight® and CRIT-LINE III with regard to intradialytic hypotensive events.
CVInsight® and CRIT-LINE III will have different predictive accuracies in recognizing IDH episodes.
Receiver Operator Characteristics analysis of CVInsight and CRIT-LINE
CVInsight: Event level thresholds will be triggered based upon new proprietary rule set.
CRIT-LINE: Change in hematocrit of 8% per hour or 15% over the treatment.
Measured: 3-4 hours, for two hemodialysis session, or 6-8 hours total
Amount of post-dialytic vascular refill as separately indicated by both CVInsight® and CRIT-LINE III.
Post-dialytic vascular refill will indirectly reflect hydration status and accuracy of dry weight estimation. Vascular refill -Ten minutes prior to the end of treatment, with UFR at zero, and BFR at same rate as during treatment, measurements will continue to be taken via the CVInsight® and CRIT-LINE devices to assess vascular refill.
CVInsight: Increase in pulse amplitude.
CRIT-LINE: Increase of 0.5% increase in hematocrit (HCT) over 10 minutes.
Measured: At the end of each dialysis session after the ultrafiltration rate (UFR) has turned off.
The occurrence and frequency of arrhythmias as indicated on the Zio ECG Patch and the levels of cardiac Troponin T, taken prior to each HD treatment. which are indicative HD-induced myocardial injury..
Arrhythmias frequency overall, on dialysis days, during long and short interdialytic periods, nocturnal, diurnal. Troponin T levels will correlate with the incidence rates of arrhythmias. Troponin T as measured by ng/mL, reference value at <0.011
Measured: 24 hours before first session of monitored dialysis to at least 24 hours after the second session on monitored dialysis sessions.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2014 (estimated)
- Study startApr 2014
- Primary completion1 Mar 2023 (estimated)
- Study completion1 Mar 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypotension of HemodialysisStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Intelomed, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Tufts Medical Center, Dialysis Clinic, Inc.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02182089
- Sponsor's protocol ID
- IntelomedTufts11231
- Status last verified
- Mar 2023
- First submitted
- 9 May 2014
- Last updated
- 3 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Measuring Cardiovascular Stress in Patients on Hemodialysis Study II
- ClinicalTrials.gov ID
- NCT02182089
- Acronym / sponsor ID
- IntelomedTufts11231
- Conditions
- Hypotension of Hemodialysis, Hypotension, Estimated Dry Weight, Myocardial Injury, Arrhythmia
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Intelomed, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Tufts Medical Center, Dialysis Clinic, Inc.
- Study start
- Apr 2014
- Primary completion
- 1 Mar 2023 (estimated)
- Study completion
- 1 Mar 2023 (estimated)
- First posted
- 8 Jul 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 overall goal is to evaluate the predictive accuracy of a measure of autoregulatory adequacy derived from CVInsight and compare it with other measures in recognizing hypotensive events during hemodialysis..
Detailed description
Specific Aims are as follows:
- Assess the accuracy of a new rule set for CVInsight® in predicting intradialytic hypotensive episodes.
- Assess the comparative predictive accuracy of CVInsight® to other measures with regard to intradialytic hypotensive events.
- Assess estimated dry weight goals by monitoring post-dialytic vascular refill using CVInsight® and other measures.
- Assess hemodialysis(HD)-induced myocardial injury by monitoring the occurrence and frequency of arrhythmias and the levels of cardiac Troponin T.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dialysis patients with greater than 20% IDH | – | –Study Population: The sample will be enriched for subjects prone to IDH, defined as patients who experience IDH for greater than 20% of HD treatments in the past 2 months. The study population will consist of 48 patients total, 75% of patients (n=36) prone to IDH and 25% of patients with less than 10% of IDH during the last two months (n=12). |
| Patients with less than 10% IDH | – | –Study Population: The sample will be enriched for subjects prone to IDH, defined as patients who experience IDH for greater than 20% of HD treatments in the past 2 months. The study population will consist of 48 patients total, 75% of patients (n=36) prone to IDH and 25% of patients with less than 10% of IDH during the last two months (n=12). |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Study Population: The sample will be enriched for subjects prone to IDH, defined as patients who experience IDH for greater than 20% of HD treatments in the past 2 months. The study population will consist of 48 patients total, 75% of patients (n=36) prone to IDH and 25% of patients with less than 10% of IDH during the last two months (n=12).
Key inclusion criteria (5 listed)
- Age ≥ 20 years old
- Speaks and understands English, Spanish or Chinese
- Provides Informed Consent
- Patients with 20% intradialytic hypotensive events over the last two months.
Key exclusion criteria (9 listed)
- Unstable hemodialysis patients per judgment of the clinician prior to the start of the treatment
- Patients unable to have blood pressure cuff measured on the upper arm
- Inability to wear monitor on forehead
- Patients treated with sodium or ultrafiltration profiling and the patient's nephrologist is unwilling to alter this for the study treatments
- Patients unwilling to shave the anterior chest
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Number of intradialytic hypotensive (IDH) episodes that can be detected by the new rule set for CVInsight.
Time frame: 3-4 hours, for two hemodialysis session, or 6-8 hours total
IDH defined by at least one of the following: 1) Symptoms of hypotension: dizziness, cramping, altered consciousness, nausea +/- vomiting (new since beginning of session), chest pain, shortness of breath, seizure, diaphoretic. 2) Intervention administered due to IDH; relevant interventions:a) a reduction in ultrafiltration (UF) goal programmed at start of treatment (tx); b) admin. of IV fluid, e.g. saline, mannitol or hypertonic saline; c) stopping tx early due to IDH symptoms or event. 3) A significant drop in blood pressure, regardless of symptoms, defined as: * For pts w/ a pre-dialysis systolic blood pressure (SBP) >110 mm Hg, an intra or post-dialysis SBP <90 mm Hg, or a drop of >40 mm Hg over 30 min. * For pts w/ a pre-dialysis SBP <110, a decline in SBP <85 mm Hg or 15 mm Hg or lower than their starting BP.
3 secondary outcomes
The comparative, predictive accuracy of CVInsight® and CRIT-LINE III with regard to intradialytic hypotensive events.
Time frame: 3-4 hours, for two hemodialysis session, or 6-8 hours total
Amount of post-dialytic vascular refill as separately indicated by both CVInsight® and CRIT-LINE III.
Time frame: At the end of each dialysis session after the ultrafiltration rate (UFR) has turned off.
The occurrence and frequency of arrhythmias as indicated on the Zio ECG Patch and the levels of cardiac Troponin T, taken prior to each HD treatment. which are indicative HD-induced myocardial injury..
Time frame: 24 hours before first session of monitored dialysis to at least 24 hours after the second session on monitored dialysis sessions.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2023.
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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.
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?
An observational study of Hypotension of Hemodialysis and Hypotension, 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 5 inclusion and 9 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: status not confirmed, as of the sponsor's last update on 3 Mar 2023. 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?
Results are not available in the source record.
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?
Number of intradialytic hypotensive (IDH) episodes that can be detected by the new rule set for CVInsight. (time frame: 3-4 hours, for two hemodialysis session, or 6-8 hours total). 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 3 Mar 2023.