Measuring Cardiovascular Stress in Patients on Hemodialysis Study II

NCT02182089 | Unknown

• 1 other identifier: IntelomedTufts11231
• Study Type: observational
• Target: 48
• Locations: 1 country
• Sites: 1

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..

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• The comparative, predictive accuracy of CVInsight® and CRIT-LINE III with regard to intradialytic hypotensive events.

  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.

  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..

  24 hours before first session of monitored dialysis to at least 24 hours after the second session on monitored dialysis sessions.

Study Arms (2)

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).

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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).

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Intelomed, Inc.: lead
• Tufts Medical Center: collaborator
• Dialysis Clinic, Inc.: collaborator

Study Sites (1)

Tufts Medical Center

Boston, Massachusetts, 02111, United States

Location

MeSH Terms

Conditions

Hypotension; Arrhythmias, Cardiac

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Heart Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 9, 2014
• First Posted: July 8, 2014
• Study Start: April 1, 2014
• Primary Completion: March 1, 2023
• Study Completion: March 1, 2023
• Last Updated: March 3, 2023

Record last verified: 2023-03

Locations

US (1)