To Assess Ear Blood Flow During Dialysis | NCT02545920

Studies
To Assess Ear Blood Flow During Dialysis

NCT02545920

Sponsor

University College, London

Status

Unknown status

Last Update Posted

Nov 4, 2020Actual

Enrollment

10Estimated

Phase

Not provided

Conditions

Kidney Failure

Interventions

no intervention

Countries

United Kingdom

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

Nov 2020

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2015Actual

Primary Completion Date

Oct 30, 2020Actual

Completion Date

Aug 30, 2021Estimated

First Submitted Date

Jul 7, 2015

First Submission Date that Met QC Criteria

Sep 7, 2015

First Posted Date

Sep 10, 2015Estimated

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

Nov 3, 2020

Last Update Posted Date

Nov 4, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

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

This is a prospective observational pilot study of patients under the care of the Royal Free Hospital with chronic kidney disease who have been established on regular thrice weekly haemodialysis treatments in a dialysis centre,to measure the changes in blood flow in the ear during haemodialysis.

Detailed Description

10 patients, attending for thrice weekly outpatient haemodiafiltration shall be studied during a dialysis session using a CE marked commercially available digital otoscope capable of recording digital videos of the tympanic membrane and ear canal.

Patients will receive standard clinical care and monitoring of their dialysis session, which includes recording of blood pressure and changes in haematocrit and volume status during dialysis and noting patient symptoms.

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

10Estimated

Name	Type	Description	Arm Group Labels	Other Names
no intervention	Other	observational study

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
change in ear blood flow	percentage change in ear blood flow compared to initial ear blood flow	day 1 dialysis session

Secondary Outcomes

Measure	Description	Time Frame
change in blood pressure	change in blood pressure in mmHg compared to starting blood pressure	day 1 dialysis session
change in haematocrit volume status	percentage change in haematocrit

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients age 18 years and older up to 80 years
Under the care of the Royal Free Hospital with chronic kidney disease and established on regular thrice weekly haemodiafiltration.
Able to provide written informed consent obtained

Exclusion Criteria:

Patients unable to provide written informed consent
Patients using hearing aids
Patients who have had previous middle ear surgery
Patients not fulfilling inclusion criteria

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

patients with chronic kidney failure attending for regular dialysis treatment

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
vashist deelchand	Contact	02077940500		vashist.deelchand@nhs.net

Overall Officials

Name	Affiliation	Role
andrew davenport	UCL Centre for Nephrology, Royal Free Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Royal Free Hospital	Recruiting	London		NW32QG	United Kingdom

Condition Browse Module

MeSH Terms

ID	Term
D051437	Renal Insufficiency
D007022	Hypotension

Ancestor Terms

ID	Term
D007674	Kidney Diseases
D014570	Urologic Diseases
D052776	Female Urogenital Diseases
D005261	Female Urogenital Diseases and Pregnancy Complications

Browse Leaves

Not provided

Browse Branches

Not provided