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?

ISRCTN	ISRCTN85001755
DOI	https://doi.org/10.1186/ISRCTN85001755
Secondary identifying numbers	N0205175497

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

Dr S Bhatia
Scientific

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

Study design	Randomised controlled 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	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?
Study objectives	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(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Surgery: Postoperative care
Intervention	Randomised controlled trial
Intervention type	Drug
Pharmaceutical study type(s)
Phase	Not Applicable
Drug / device / biological / vaccine name(s)	Ringer-Lactate/1% dextrose, dextrose saline
Primary outcome measure	Frequency of hyponatraemia
Secondary outcome measures	Not provided at time of registration
Overall study start date	06/04/2005
Completion date	06/07/2006

Participant type(s)	Patient
Age group	Child
Lower age limit	1 Month
Upper age limit	12 Years
Sex	Both
Target number of participants	Not provided at time of registration
Key inclusion criteria	Children aged 1 month - 12 years undergoing inpatient general surgery
Key exclusion criteria	Not provided at time of registration
Date of first enrolment	06/04/2005
Date of final enrolment	06/07/2006

The Royal London Hospital

London
E1 1BB
United Kingdom

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

The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Government

Barts and The London NHS Trust (UK)

No information available

NHS R&D Support Funding

No information available

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