Myocardial stunning during paediatric dialysis and the effects of cooling the dialystate during haemodialysis

ISRCTN	ISRCTN78749497
DOI	https://doi.org/10.1186/ISRCTN78749497
Protocol serial number	5119
Sponsor	Great Ormond Street Hospital for Children (UK)
Funder	Kids Kidney Research (UK)

Submission date: 29/04/2010
Registration date: 29/04/2010
Last edited: 12/04/2017

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Urological and Genital Diseases

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Daljit Hothi
Scientific

30 Guilford Street
London
WC1N 1EH
United Kingdom

Study information

Primary study design	Interventional
Study design	Randomised interventional treatment trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title	Myocardial stunning during paediatric dialysis and the effects of cooling the dialystate during haemodialysis: a randomised interventional treatment trial
Study objectives	Original hypotheses: In comparison to standard 37ºC dialysate, dialysate temperature 0.5ºC below core body temperature reduces: 1. HD-induced regional LV dysfunction (myocardial stunning) 2. The incidence of IDH and therefore improves the potential for fluid removal during HD (UF) 3. The side effects of IDH and therefore improves the dialysis experience for the child 4. Circulating surrogate markers of myocardial injury Aim of this pilot: Primary aim was to determine whether using dialysate 0.5°C cooler than body temperature is associated with a decrease in acute left ventricular (LV) dysfunction as measured by 2D speckle tracking within limits of patient tolerability of feeling cold.
Ethics approval(s)	National Research Ethics Service, Central London REC 2, 31/07/2007, ref: 07/Q0508/64
Health condition(s) or problem(s) studied	Topic: Renal and Urogenital; Subtopic: Renal and Urogenital (all Subtopics); Disease: Renal
Intervention	The patient will be randomised to cooled dialysate or dialysate temperature of 37ºC. Follow-up length: 24 months Study entry: single randomisation only
Intervention type	Other
Primary outcome measure(s)	Regional LV dysfunction; patients will undergo echocardiogram assessments at 0, 15 and 240 minutes post-dialysis
Key secondary outcome measure(s)	To determine the differences between cooled and standard dialysate in the: 1. Incidence of hypotensive episodes (IDH) defined as a blood pressure (BP) below the 5th percentile adjusted for age and sex 2. Incidence of self-reported intradialytic and postdialytic symptoms 3. Quality of the dialysis procedure based on a specific questionnaire designed to assess their treatment experience and symptoms related to feeling cold during dialysis 4. UF achieved, calculated as the ratio of actual UF volume and desired UF volume
Completion date	01/07/2011

Eligibility

Participant type(s)	Patient
Age group	Child
Lower age limit	1 Month
Sex	All
Target sample size at registration	40
Key inclusion criteria	1. Children on conventional 4 hours three times/week dialysis 2. Stable on dialysis for 2 months 3. Male and female, lower age limit of 1 month
Key exclusion criteria	Difficult echocardiogram assessments
Date of first enrolment	01/12/2007
Date of final enrolment	01/07/2011

Locations

Countries of recruitment

United Kingdom
England

Study participating centre

30 Guilford Street

London
WC1N 1EH
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes

Editorial Notes

12/04/2017: No publications found in PubMed, verifying study status with principal investigator.