Overview

This trial is active, not recruiting.

Conditions hypotension of hemodialysis, hypotension, estimated dry weight, myocardial injury, arrhythmia
Sponsor Intelomed, Inc.
Collaborator Tufts Medical Center
Start date April 2014
End date August 2015
Trial size 48 participants
Trial identifier NCT02182089, IntelomedTufts11231

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..

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective
Arm
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).
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).

Primary Outcomes

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

Secondary Outcomes

Measure
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.

Eligibility Criteria

Male or female participants at least 20 years old.

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.

Additional Information

Official title Measuring Cardiovascular Stress in Patients on Hemodialysis Study II
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.
Trial information was received from ClinicalTrials.gov and was last updated in July 2015.
Information provided to ClinicalTrials.gov by Intelomed, Inc..