NCT02545920

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
10

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Sep 2015

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 7, 2015

Completed
2 months until next milestone

Study Start

First participant enrolled

September 1, 2015

Completed
9 days until next milestone

First Posted

Study publicly available on registry

September 10, 2015

Completed
5.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2020

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2021

Completed
Last Updated

November 4, 2020

Status Verified

November 1, 2020

Enrollment Period

5.2 years

First QC Date

July 7, 2015

Last Update Submit

November 3, 2020

Conditions

Kidney Failure

Keywords

haemodialysishypotension

Outcome Measures

Primary Outcomes (1)

  • change in ear blood flow

    percentage change in ear blood flow compared to initial ear blood flow

    day 1 dialysis session

Secondary Outcomes (3)

  • change in blood pressure

    day 1 dialysis session

  • change in haematocrit volume status

    day 1 dialysis session

  • record of hypotensive episodes during dialysis

    day 1 dialysis session

Interventions

no interventionOTHER

observational study

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

patients with chronic kidney failure attending for regular dialysis treatment

You may qualify if:

  • 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

You may not qualify if:

  • Patients unable to provide written informed consent
  • Patients using hearing aids
  • Patients who have had previous middle ear surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Royal Free Hospital

London, NW32QG, United Kingdom

RECRUITING

MeSH Terms

Conditions

Renal InsufficiencyHypotension

Condition Hierarchy (Ancestors)

Kidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • andrew davenport

    UCL Centre for Nephrology, Royal Free Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

vashist deelchand

CONTACT

02077940500vashist.deelchand@nhs.net

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 7, 2015

First Posted

September 10, 2015

Study Start

September 1, 2015

Primary Completion

October 30, 2020

Study Completion

August 30, 2021

Last Updated

November 4, 2020

Record last verified: 2020-11

Locations

GB(1)