Condition category
Urological and Genital Diseases
Date applied
29/04/2010
Date assigned
29/04/2010
Last edited
11/08/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Daljit Hothi

ORCID ID

Contact details

30 Guilford Street
London
WC1N 1EH
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

5119

Study information

Scientific title

Myocardial stunning during paediatric dialysis and the effects of cooling the dialystate during haemodialysis: a randomised interventional treatment trial

Acronym

Study hypothesis

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

National Research Ethics Service, Central London REC 2, 31/07/2007, ref: 07/Q0508/64

Study design

Randomised interventional treatment trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

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

Phase

Not Applicable

Drug names

Primary outcome measures

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 trial start date

01/12/2007

Overall trial end date

01/07/2011

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Child

Gender

Both

Target number of participants

Planned Sample Size: 40

Participant exclusion criteria

Difficult echocardiogram assessments

Recruitment start date

01/12/2007

Recruitment end date

01/07/2011

Locations

Countries of recruitment

United Kingdom

Trial participating centre

30 Guilford Street
London
WC1N 1EH
United Kingdom

Sponsor information

Organisation

Great Ormond Street Hospital for Children (UK)

Sponsor details

Department of Paediatric Oncology
Great Ormond Street
London
WC1N 3JH
United Kingdom

Sponsor type

Hospital/treatment centre

Website

http://www.ich.ucl.ac.uk/

Funders

Funder type

Charity

Funder name

Kids Kidney Research (UK)

Alternative name(s)

KKR

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

Location

United Kingdom

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes