Early Warning of Intradialytic Hypotension in Hemodialysi... | NCT04680039

Studies
Early Warning of Intradialytic Hypotension in Hemodialysis Patients

NCT04680039

Sponsor

Biobeat Technologies Ltd.

Status

Completed

Last Update Posted

Jul 20, 2022Actual

Enrollment

150Actual

Phase

Not provided

Conditions

Hypotension of Hemodialysis

Interventions

Continuous monitoring

Countries

Israel

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2022

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 15, 2021Actual

Primary Completion Date

Feb 15, 2022Actual

Completion Date

Mar 15, 2022Actual

First Submitted Date

Dec 14, 2020

First Submission Date that Met QC Criteria

Dec 20, 2020

First Posted Date

Dec 22, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 19, 2022

Last Update Posted Date

Jul 20, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Yes

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

Brief Summary

In this study, the investigators will monitor patients undergoing hemodialysis treatment with a non-invasive wearable PPG-based device. Measurements will include blood pressure, heart rate, oxygen saturation, stroke volume, cardiac output, cardiac index and systemic vascular resistance, among others. The aim is to diagnose intradialytic hypotension more rapidly than with current noninvasive methods and prevent related poor outcomes.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

150Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Continuous monitoring	Device	Identifying intradialytic hypotension using a PPG-based wearable monitor

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of participants with intradialytic hypotension	Using a PPG-based non-invasive wearable monitor to allow early detection of intradialytic hypotension	Through study completion, an average of 1 year.

Secondary Outcomes

Measure	Description	Time Frame
Determining the pathogenesis of intradialytic hypotension	Continuous monitoring of numerous hemodynamic parameters will allow to determine the pathogenesis	Through study completion, an average of 1 year.

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients with EKSD undergoing chronic hemodialysis treatments for > 3 months.
Patients must be able to adhere to the visit schedule and protocol requirements and be available to complete the study.
Patients must satisfy a medical examiner about their fitness to participate in the study.
Patients must provide written informed consent to participate in the study.

Exclusion Criteria:

Patients with an inability to communicate well with the Principal investigator (PI) and staff (i.e., language problem, poor mental development, or impaired cerebral function).
Withholding the dialysis session for any reason prior to initiation.
Minors under the age of 18.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

120 Years

Standard Ages

AdultOlder Adult

Study Population

150 adult subjects (≥18 years) with end stage kidney disease (ESKD) undergoing chronic hemodialysis (HD) treatments in Hadassah Ein-Kerem medical center. A patient can participate more than once.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Dean Nachman, MD	The Hadassah Ein Kerem Medical Center, Jerusalem, Israel	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
The Hadassah Ein Kerem Medical Center		Jerusalem		91120	Israel

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000095583	Continuous Glucose Monitoring

Ancestor Terms

ID	Term
D001774	Blood Chemical Analysis
D019963	Clinical Chemistry Tests
D019411	Clinical Laboratory Techniques
D019937	Diagnostic Techniques and Procedures

Browse Leaves

Not provided

Browse Branches

Not provided