To Assess Ear Blood Flow During Dialysis

Kidney Failure Clinical Trial

Official title:

Pilot Study to Assess the Effects of Haemodialysis Treatments on Blood Flow to the Ear

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02545920
• Other study ID #: 15/0310
• Status: Recruiting
• Start date: September 2015
• Est. completion date: August 30, 2021

Study information

• Verified date: November 2020
• Source: University College, London
• Contact: vashist deelchand
• Phone: 02077940500
• Email: vashist.deelchand[@]nhs.net
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10
• Est. completion date: August 30, 2021
• Est. primary completion date: October 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Kidney Failure
• Renal Insufficiency

Intervention

Other:
• no intervention
observational study

Locations

Country	Name	City	State
United Kingdom	Royal Free Hospital	London

Sponsors (1)

Lead Sponsor	Collaborator
University College, London

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	change in ear blood flow	percentage change in ear blood flow compared to initial ear blood flow	day 1 dialysis session
Secondary	change in blood pressure	change in blood pressure in mmHg compared to starting blood pressure	day 1 dialysis session
Secondary	change in haematocrit volume status	percentage change in haematocrit	day 1 dialysis session
Secondary	record of hypotensive episodes during dialysis	record of nursing interventions including reduction in ultrafiltration volume, administration of intravenous fluids. Use of distress thermometer visual analogue scale to record patient symptoms	day 1 dialysis session