Condition category
Surgery
Date applied
29/09/2006
Date assigned
29/09/2006
Last edited
07/09/2015
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 S Bhatia

ORCID ID

Contact details

Anaesthetic Department
The Royal London Hospital
Whitechapel
London
E1 1BB
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0205175497

Study information

Scientific title

A comparison of different regimes for post-operative maintenance fluid therapy in children undergoing general surgical procedures. What is the incidence of blood sodium and glucose abnormalities?

Acronym

Study hypothesis

Does the use of Ringer-Lactate/1% dextrose as post-operative IV fluid result in a lower frequency of post-operative hyponatraemia compared with the use of dextrose saline (current standard)?

Ethics approval

Not provided at time of registration

Study design

Randomised controlled 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

Surgery: Postoperative care

Intervention

Randomised controlled trial

Intervention type

Drug

Phase

Not Applicable

Drug names

Ringer-Lactate/1% dextrose, dextrose saline

Primary outcome measures

Frequency of hyponatraemia

Secondary outcome measures

Not provided at time of registration

Overall trial start date

06/04/2005

Overall trial end date

06/07/2006

Reason abandoned

Eligibility

Participant inclusion criteria

Children aged 1 month - 12 years undergoing inpatient general surgery

Participant type

Patient

Age group

Child

Gender

Both

Target number of participants

Not provided at time of registration

Participant exclusion criteria

Not provided at time of registration

Recruitment start date

06/04/2005

Recruitment end date

06/07/2006

Locations

Countries of recruitment

United Kingdom

Trial participating centre

The Royal London Hospital
London
E1 1BB
United Kingdom

Sponsor information

Organisation

Record Provided by the NHSTCT Register - 2006 Update - Department of Health

Sponsor details

The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 (0)20 7307 2622
dhmail@doh.gsi.org.uk

Sponsor type

Government

Website

http://www.dh.gov.uk/Home/fs/en

Funders

Funder type

Government

Funder name

Barts and The London NHS Trust (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

NHS R&D Support Funding

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

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