Measuring Cardiovascular Stress in Patients on Hemodialysis Study II

Hypotension Clinical Trial

Official title:

Measuring Cardiovascular Stress in Patients on Hemodialysis Study II

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02182089
• Other study ID #: IntelomedTufts11231
• Status: Active, not recruiting
• Start date: April 2014
• Est. completion date: March 1, 2023

Study information

• Verified date: March 2023
• Source: Intelomed, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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..

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 48
• Est. completion date: March 1, 2023
• Est. primary completion date: March 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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.

Related Conditions & MeSH terms

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

Locations

Country	Name	City	State
United States	Tufts Medical Center	Boston	Massachusetts

Sponsors (3)

Lead Sponsor	Collaborator
Intelomed, Inc.	Dialysis Clinic, Inc., Tufts Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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.
Secondary	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.