Plain English Summary
Background and study aims
Haemodialysis (also known as dialysis) is a therapy option for those whose kidneys do not work. This involves removing water and excess electrolytes (chemicals that maintain muscles) in a three to four hour session attached to the dialysis machine three times a week. It has been suggested that sudden cardiac death (SCD) contributes around 50% of cardiovascular mortality and up to 27% of all causes of death in haemodialysis patients. Identifying deaths that are truly sudden and cardiac can be challenging particularly in kidney failure and the true burden of arrhythmias and arrhythmic deaths in this population has been poorly studied. The aim of this study is to use a implantable loop recorder (ILR) device inserted into dialysis patients to continuously record their ECG (heart rhythm) and monitor cardiac events until death, battery life depletion of the ILR, explant of the device (for whatever reason in order to offer the longest follow up period of continuous ECG monitoring in this population to date.
Who can participate?
Adults aged 18 and older with end stage renal failure who are receiving regular dialysis
What does the study involve?
Participants who receive dialysis three times are week receive the ILR device. It is implanted in the left chest area. This device provides continuous ECG monitoring and data can be reviewed remotely by staff. Participants are trained on how to download their own data at each of their dialysis sessions. Device downloads are reviewed by researchers for any significant cardiac events. Participants are followed up until the end of the battery life, death or they require the ILR to be removed.
What are the possible benefits and risks of participating?
There are no notable benefits with participating, however it does help develop a better understanding of heat rhythm abnormalities for dialysis patients. There are potential risks of infection as well as pain/bruising associated with the implanting of the device.
Where is the study run from?
1. Southampton General Hospital (UK)
2. Queen Alexandra Hospital (UK)
When is the study starting and how long is it expected to run for?
July 2009 to December 2017
Who is funding the study?
Medtronic PLD (UK)
Who is the main contact?
Miss Elizabeth Greenwood
elizabeth.greenwood@uhs.nhs.uk
Trial website
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
8356
Study information
Scientific title
Cardio-Renal Arrhythmia Study in Haemodialysis patients using Implantable Loop Recorders (CRASH-ILR)
Acronym
Study hypothesis
An implantable loop recorder may identify whether certain patients who have end stage renal disease on dialysis are at an increased risk of cardiac arrhythmias.
Ethics approval
NRES Committee South Central – Hampshire A, 04/12/2009, ref: 09/H0502/121
Study design
; Interventional; Design type: Device
Primary study design
Interventional
Secondary study design
Non randomised study
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
See additional files
Condition
Specialty: Cardiovascular disease, Primary sub-specialty: Arrhythmia
Intervention
Participants are recruited from a single tertiary nephrology centre in the UK and all were receiving haemodialysis three times a week.
Participants receive the intervention of the having an implantable loop recorder (ILR) device (Reveal XT®) implanted in the left parasternal region. ILRs are routinely used in clinical practice for the diagnosis of arrhythmias, have around a 3 year battery life and the data they capture can be transmitted using a secure website from a telephone landline or mobile to a computer. ILRs are cardiac devices which provide continuous ECG monitoring & this data can be transmitted regularly for review remotely. Device programming is standardised to include automatic detection of brady/tachy arrhythmias and patient activated recordings. Participants are trained on how to transmit data from their device at each dialysis session via the remote monitoring CareLink system (Medtronic). Every device download (following successful transmission) is manually scrutinised independently by two members of the research team.
Participants are followed up was from their day of implantation to death, explant or end of battery life of ILR depending on whichever came first.
Any cardiac event considered to be of clinical significance was relayed to the nephrologist involved in the patient’s care.
Intervention type
Other
Phase
Drug names
Primary outcome measures
1. Sudden cardiac death (SCD) is measured using continuous ECG data downloaded from the ILR device. In addition to clinical information and post mortem examination where performed.
2. Implantation of pacing device is measured by reporting the number of pacemakers or defibrillators that were implanted during the course of the study.
Secondary outcome measures
Development of significant arrhythmia necessitating medical intervention is measured using continuous ECG data from the ILR device.
Overall trial start date
13/07/2009
Overall trial end date
31/12/2017
Reason abandoned
Eligibility
Participant inclusion criteria
1. End Stage Renal Failure (ESRF)
2. Received regular haemodialysis for a minimum of 90 days prior to study entry and is expected to continue with haemodialysis indefinitely or until renal transplant
3. At least 18 years of age
4. Willing and able to comply with investigational plan and willing to remain available for follow-up through to study closure
5. Willing and able to sign/date the study informed consent
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
Planned Sample Size: 30; UK Sample Size: 30
Participant exclusion criteria
1. Myocardial infarction in preceding 40 days prior to enrolment
2. Already implanted with a cardiac device, such as pacemaker, defibrillator or implantable loop recorder (ILR)
3. Life expectancy less than one year in the opinion of an Investigator
4. Enrolled in another research study
5. Expected to have poor compliance with the study protocol
6. Pregnancy or breastfeeding
7. Haemodialysis via leftsided tunnelled central venous catheter
8. Expected to require a thoracic magnetic resonance image (MRI)
Recruitment start date
30/08/2011
Recruitment end date
23/10/2014
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Southampton General Hospital (Lead Site)
CRM Research Office
Mailpoint 46
Tremona Road
Southampton
SO16 6YD
United Kingdom
Trial participating centre
Queen Alexandra Hospital
Cardiology Research
Southwick Hill Road
Cosham
Portsmouth
PO6 3LY
United Kingdom
Funders
Funder type
Government
Funder name
Medtronic Ltd
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Planned publication in a peer reviewed journal. An abstract summarising interim results was presented at AHA Conference, Texas, Dallas 2013 summarising the findings after 188,880 hours of continuous monitoring.
IPD sharing statement:
The datasets generated and/or analysed during the current study during this study will be included in the subsequent results publication.
Intention to publish date
01/09/2017
Participant level data
Other
Results - basic reporting
Publication summary
2017 results in: https://www.ncbi.nlm.nih.gov/pubmed/29240772
Publication citations
Additional files
- ISRCTN35846572_PIS_17Feb12_V1.47.pdf Uploaded 28/06/2017
- ISRCTN35846572_PIS_17Feb12_V1.47.pdf Uploaded 12/07/2017