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
Protocol serial number N0205175497
Sponsor Record Provided by the NHSTCT Register - 2006 Update - Department of Health
Funders Barts and The London NHS Trust (UK), NHS R&D Support Funding
Submission date
29/09/2006
Registration date
29/09/2006
Last edited
07/09/2015
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Surgery
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 S Bhatia
Scientific

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

Study information

Primary study designInterventional
Study designRandomised controlled trial
Secondary study designRandomised controlled trial
Study type Participant information sheet
Scientific titleA 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 objectivesDoes 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) studiedSurgery: Postoperative care
InterventionRandomised controlled trial
Intervention typeDrug
PhaseNot Applicable
Drug / device / biological / vaccine name(s)Ringer-Lactate/1% dextrose, dextrose saline
Primary outcome measure(s)

Frequency of hyponatraemia

Key secondary outcome measure(s)

Not provided at time of registration

Completion date06/07/2006

Eligibility

Participant type(s)Patient
Age groupChild
Lower age limit1 Month
Upper age limit12 Years
SexAll
Key inclusion criteriaChildren aged 1 month - 12 years undergoing inpatient general surgery
Key exclusion criteriaNot provided at time of registration
Date of first enrolment06/04/2005
Date of final enrolment06/07/2006

Locations

Countries of recruitment

  • United Kingdom
  • England

Study participating centre

The Royal London Hospital
London
E1 1BB
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot 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