Measuring Cardiovascular Stress in Patients on Hemodialysis Study II

Intelomed

Status: Active, not recruiting

Conditions: Hypotension; Arrhythmia; Estimated Dry Weight; Hypotension of Hemodialysis; Myocardial Injury

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT02182089

IntelomedTufts11231

Details and patient eligibility

About

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..

Full 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.

Enrollment: 48 estimated patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

48 participants in 2 patient groups

Dialysis patients with greater than 20% IDH

Description:

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

Description:

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).