Myocardial stunning during paediatric dialysis and the effects of cooling the dialystate during haemodialysis
| ISRCTN | ISRCTN78749497 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN78749497 |
| Secondary identifying numbers | 5119 |
- 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
Scientific
30 Guilford Street
London
WC1N 1EH
United Kingdom
Study information
| Study design | Randomised interventional treatment trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient 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 | Regional LV dysfunction; patients will undergo echocardiogram assessments at 0, 15 and 240 minutes post-dialysis |
| Secondary outcome measures | 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 |
| Overall study start date | 01/12/2007 |
| Completion date | 01/07/2011 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Lower age limit | 1 Month |
| Sex | Both |
| Target number of participants | Planned Sample Size: 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
- England
- United Kingdom
Study participating centre
30 Guilford Street
London
WC1N 1EH
United Kingdom
WC1N 1EH
United Kingdom
Sponsor information
Great Ormond Street Hospital for Children (UK)
Hospital/treatment centre
Hospital/treatment centre
Department of Paediatric Oncology
Great Ormond Street
London
WC1N 3JH
England
United Kingdom
| Website | http://www.ich.ucl.ac.uk/ |
|---|---|
"ROR" |
https://ror.org/03zydm450 |
Funders
Funder type
Charity
Kids Kidney Research (UK)
Private sector organisation / Other non-profit organizations
Private sector organisation / Other non-profit organizations
- Alternative name(s)
- KKR
- Location
- United Kingdom
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Editorial Notes
12/04/2017: No publications found in PubMed, verifying study status with principal investigator.
