To Assess Ear Blood Flow During Dialysis

• Conditions: Kidney Failure

• Registration Number: NCT02545920
• Lead Sponsor: University College, London

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.

Study Timeline

• Study First Submitted: 2015-07-07
• Study Start: 2015-09
• Study First Submitted QC: 2015-09-07
• Study First Posted: 2015-09-10
• Primary Completion: 2020-10-30
• Status Verified: 2020-11
• Last Update Submitted: 2020-11-03
• Last Update Posted: 2020-11-04
• Study Completion: 2021-08-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 10

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
change in ear blood flow	day 1 dialysis session	percentage change in ear blood flow compared to initial ear blood flow

Secondary Outcome Measures

Name	Time	Method
change in blood pressure	day 1 dialysis session	change in blood pressure in mmHg compared to starting blood pressure
change in haematocrit volume status	day 1 dialysis session	percentage change in haematocrit
record of hypotensive episodes during dialysis	day 1 dialysis session	record of nursing interventions including reduction in ultrafiltration volume, administration of intravenous fluids. Use of distress thermometer visual analogue scale to record patient symptoms

Trial Locations

Locations (1)

Royal Free Hospital; 🇬🇧 London, United Kingdom