Clinical trial NCT02182089: Measuring Cardiovascular Stress in Patients on Hemodialysis Study II
Official title: Measuring Cardiovascular Stress in Patients on Hemodialysis Study II
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Hypotension of Hemodialysis
Hypotension
Estimated Dry Weight
Myocardial Injury
Arrhythmia
Lead sponsor: Intelomed, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Tufts Medical Center
name: Dialysis Clinic, Inc.
First posted: 2014-07-08
Enrollment: 48
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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).

Brief 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..

Detailed description: Specific Aims are as follows:

1. Assess the accuracy of a new rule set for CVInsight® in predicting intradialytic hypotensive episodes.
2. Assess the comparative predictive accuracy of CVInsight® to other measures with regard to intradialytic hypotensive events.
3. Assess estimated dry weight goals by monitoring post-dialytic vascular refill using CVInsight® and other measures.
4. Assess hemodialysis(HD)-induced myocardial injury by monitoring the occurrence and frequency of arrhythmias and the levels of cardiac Troponin T.

Eligibility criteria: Inclusion Criteria:

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.

Exclusion criteria for both groups:

* 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.
* 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.

Primary outcomes:
measure: Number of intradialytic hypotensive (IDH) episodes that can be detected by the new rule set for CVInsight.
timeFrame: 3-4 hours, for two hemodialysis session, or 6-8 hours total
Secondary outcomes:
measure: The comparative, predictive accuracy of CVInsight® and CRIT-LINE III with regard to intradialytic hypotensive events.
timeFrame: 3-4 hours, for two hemodialysis session, or 6-8 hours total
measure: Amount of post-dialytic vascular refill as separately indicated by both CVInsight® and CRIT-LINE III.
timeFrame: At the end of each dialysis session after the ultrafiltration rate (UFR) has turned off.
measure: 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..
timeFrame: 24 hours before first session of monitored dialysis to at least 24 hours after the second session on monitored dialysis sessions.
Other outcomes:
Locations:
city: Boston
country: United States
facility: Tufts Medical Center
state: Massachusetts
Study officials:
References: