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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: SLCTR
Last refreshed on: 27 April 2013
Main ID:  SLCTR/2008/013
Date of registration: 20/06/2008
Primary sponsor: Faculty of Medicine, University of Peradeniya
Public title: Preoperative intravenous fluid administration versus non administration in hip/knee prosthesis surgery in old age and outcome
Scientific title: Liberal versus restrictive preoperative fluid administration and outcome following hip/knee prosthesis surgery in old age
Date of first enrolment: 1/6/2008
Target sample size: 60
Recruitment status: Completed
URL:  http://www.slctr.lk/trial_details.asp?reg_id={714CF94C-6F2E-42FD-818C-C210DCADC8C1}
Study type:  Interventional
Study design:  This is a randomized control clinical trial. The standard envelop method will be used to allocate patients to wet or dry regimes. The study period will be two years duration  
Countries of recruitment
Sri Lanka
Contacts
Name: Prof. C.D.A. Goonasekera 
Address:  Department of Anaesthesiology, Faculty of Medicine, University of Peradeniya.
Telephone: 0712771507
Email: cgoonase@slt.lk
Affiliation:  Head/Dept. of Anaesthesiology
Name: Prof. C.D.A. Goonasekera 
Address:  Head/Department of Anaesthesiology , Faculty of Medicine, University of Peradeniya
Telephone: 00940712771507
Email: cgoonase@slt.lk
Affiliation:  Head/Departmet of Medicine
Key inclusion & exclusion criteria
Inclusion criteria: 1. Consenting patients admitted to orthopedic ward, Teaching Hospital Peradeniya for hip/knee prosthesis surgery.

2. Age above 60

Exclusion criteria: Ongoing infection(elevated c reactive protein)

Venous canula in situ(central or peripheral)

No consent


Age minimum:
Age maximum:
Gender:
Health Condition(s) or Problem(s) studied
Hip or knee prosthesis surgery
Intervention(s)
The trearment arm of patients will receive iv fluidsless thanBR>(2 liters of dextrose saline) for 24 hours prior to surgery in addition to normal oral intake until 6 hours before surgery. Other aspects of preoperative management will be standard
Primary Outcome(s)
1.Recovery parameters

•Duration of ICU stay

•Duration of hospital stay postoperatively

•Morbidity during first 3 months

•Mortality within 3 months


2.Health attributes

-Functional status

-Well being

-Overall health
Secondary Outcome(s)
1. Postoperative complications

- Infection

- Reoperation

- comorbidity
Secondary ID(s)
None
Source(s) of Monetary Support
University of Peradeniya
Secondary Sponsor(s)
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