Correlation of Ultrafiltered Volume (UFV) to Bioimpedance... | NCT04937478

Studies
Correlation of Ultrafiltered Volume (UFV) to Bioimpedance Changes

NCT04937478

Sponsor

Mode Sensors AS

Status

Completed

Last Update Posted

Apr 18, 2023Actual

Enrollment

31Actual

Phase

Not provided

Conditions

Hemodialysis, Ultrafiltration, Bioimpedance

Interventions

Observation

Countries

Norway

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

Apr 2023

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

Apr 20, 2021Actual

Primary Completion Date

Jun 14, 2021Actual

Completion Date

Dec 30, 2021Actual

First Submitted Date

Jun 16, 2021

First Submission Date that Met QC Criteria

Jun 16, 2021

First Posted Date

Jun 24, 2021Actual

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

Apr 14, 2023

Last Update Posted Date

Apr 18, 2023Actual

Name	Class
St. Olavs Hospital	OTHER
Helse Nord-Trøndelag HF	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Patient submitted to hemodialysis are followed through a dialysis - interim - dialysis cycle.

No intervention is done. Additional blood tests and clinical tests are used as pseudo-endpoints. Correlation is made to ultrafiltrated volume (UFV).

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

Retention

Enrollment

31Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Hemodialysis patients		Patients who undergo hemodialysis in hospital every two to three days.	Other: Observation

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Observation	Other	Only observational study, no intervention.	Hemodialysis patients

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Correlation between ultrafiltered volume (UFV) and measured bioimpedance change	A change in measured thoracic bioimpedance is expected to correlate to UFV	During hemodialysis

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

patients scheduled for hemodialysis
signed Informed Consent Form

Exclusion Criteria:

acute intercurrent disease,
subjects with known hypersensitivity to plasters (adhesive or gel).

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patients treated with hemodialysis for survival.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Levanger Hospital		Levanger			Norway
St Olavs university hospital

IPD Sharing Statement Module

Plan to Share IPD

Description

Individual participant data will not be shared

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D019370	Observation

Ancestor Terms

ID	Term
D008722	Methods
D008919	Investigative Techniques

Browse Leaves

Not provided

Browse Branches

Not provided