Measuring Cardiovascular Stress in Patients on Hemodialysis Study II

NCT ID: NCT02182089

Last Updated: 2023-03-03

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 48 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2014-04-30
• Study Completion Date: 2023-03-01

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.

Conditions

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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).

No interventions assigned to this group

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).

No interventions assigned to this group

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

• 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.

• Minimum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Tufts Medical Center

OTHER

Sponsor Role: collaborator

Dialysis Clinic, Inc.

INDUSTRY

Sponsor Role: collaborator

Intelomed, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Tufts Medical Center

Boston, Massachusetts, United States

Countries

United States

Other Identifiers

IntelomedTufts11231

Identifier Type: -

Identifier Source: org_study_id