Measuring Cardiovascular Stress in Patients on Hemodialysis Study II

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..

Study Overview

• Status: Active, not recruiting
• Conditions: Myocardial Injury; Arrhythmia; Hypotension; Hypotension of Hemodialysis; Estimated Dry Weight

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.

• Study Type: Observational
• Enrollment (Anticipated): 48

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02111
      • Tufts Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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).

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
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 the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	3-4 hours, for two hemodialysis session, or 6-8 hours total

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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	24 hours before first session of monitored dialysis to at least 24 hours after the second session on monitored dialysis sessions.

Collaborators and Investigators

• Sponsor: Intelomed, Inc.
• Collaborators: Tufts Medical Center; Dialysis Clinic, Inc.

Study record dates

Study Major Dates

• Study Start: April 1, 2014
• Primary Completion (Anticipated): March 1, 2023
• Study Completion (Anticipated): March 1, 2023

Study Registration Dates

• First Submitted: May 9, 2014
• First Submitted That Met QC Criteria: July 4, 2014
• First Posted (Estimate): July 8, 2014

Study Record Updates

• Last Update Posted (Actual): March 3, 2023
• Last Update Submitted That Met QC Criteria: March 1, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypotension
• Other Study ID Numbers: IntelomedTufts11231