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 |
- 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
Scientific
Anaesthetic Department
The Royal London Hospital
Whitechapel
London
E1 1BB
United Kingdom
Study information
| 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 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Lower age limit | 1 Month |
| Upper age limit | 12 Years |
| Sex | All |
| 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 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
The Royal London Hospital
London
E1 1BB
United Kingdom
E1 1BB
United Kingdom
Sponsor information
Record Provided by the NHSTCT Register - 2006 Update - Department of Health
Government
Government
The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
| Phone | +44 (0)20 7307 2622 |
|---|---|
| dhmail@doh.gsi.org.uk | |
| Website | http://www.dh.gov.uk/Home/fs/en |
Funders
Funder type
Government
Barts and The London NHS Trust (UK)
No information available
NHS R&D Support Funding
No information available
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 |
