Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Measuring Cardiovascular Stress in Patients on Hemodialysis Study II

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02182089
Recruitment Status : Unknown
Verified July 2015 by Intelomed, Inc..
Recruitment status was:  Active, not recruiting
First Posted : July 8, 2014
Last Update Posted : July 21, 2015
Sponsor:
Collaborators:
Tufts Medical Center
Dialysis Clinic, Inc.
Information provided by (Responsible Party):
Intelomed, Inc.

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..

Condition or disease
Hypotension of Hemodialysis Hypotension Estimated Dry Weight Myocardial Injury Arrhythmia

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.

Layout table for study information
Study Type : Observational
Estimated Enrollment : 48 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Measuring Cardiovascular Stress in Patients on Hemodialysis Study II
Study Start Date : April 2014
Estimated Primary Completion Date : August 2015
Estimated Study Completion Date : August 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dialysis

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).




Primary Outcome Measures :
  1. Number of intradialytic hypotensive (IDH) episodes that can be detected by the new rule set for CVInsight. [ Time Frame: 3-4 hours, for two hemodialysis session, or 6-8 hours total ]

    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.


Secondary Outcome Measures :
  1. The comparative, predictive accuracy of CVInsight® and CRIT-LINE III with regard to intradialytic hypotensive events. [ Time Frame: 3-4 hours, for two hemodialysis session, or 6-8 hours total ]

    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.


  2. Amount of post-dialytic vascular refill as separately indicated by both CVInsight® and CRIT-LINE III. [ Time Frame: At the end of each dialysis session after the ultrafiltration rate (UFR) has turned off. ]

    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.


  3. 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.. [ Time Frame: 24 hours before first session of monitored dialysis to at least 24 hours after the second session on monitored dialysis sessions. ]
    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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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).

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02182089


Locations
Layout table for location information
United States, Massachusetts
Tufts Medical Center
Boston, Massachusetts, United States, 02111
Sponsors and Collaborators
Intelomed, Inc.
Tufts Medical Center
Dialysis Clinic, Inc.
Layout table for additonal information
Responsible Party: Intelomed, Inc.
ClinicalTrials.gov Identifier: NCT02182089    
Other Study ID Numbers: IntelomedTufts11231
First Posted: July 8, 2014    Key Record Dates
Last Update Posted: July 21, 2015
Last Verified: July 2015
Additional relevant MeSH terms:
Layout table for MeSH terms
Hypotension
Cardiovascular Diseases
Vascular Diseases