Home » Trials » SLCTR/2008/013
Liberal versus restrictive preoperative fluid administration and outcome following hip/knee prosthesis surgery in old age
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SLCTR Registration Number
SLCTR/2008/013
Date of Registration
The date of last modification
Mar 03, 2019
Trial Status
Scientific Title of Trial
Liberal versus restrictive preoperative fluid administration and outcome following hip/knee prosthesis surgery in old age
Public Title of Trial
Preoperative intravenous fluid administration versus non administration in hip/knee prosthesis surgery in old age and outcome
Disease or Health Condition(s) Studied
Hip or knee prosthesis surgery
Scientific Acronym
None
Public Acronym
None
Brief title
"Which fluid regime is best in old age orthopedic surgery? Be Wet or Dry?"
Universal Trial Number
None
Any other number(s) assigned to the trial and issuing authority
None
What is the research question being addressed?
Whether liberal vs restrictive administration of preoperative fluids affects the outcome of patients undergoing hip/knee prosthesis surgery in old age ?
Type of study
Interventional
Study design
Allocation
Randomized controlled trial
Masking
Masking not used
Control
Standard therapy/practice
Assignment
Parallel
Purpose
Supportive care
Study Phase
Not Available
Intervention(s) planned
The treatment arm of patients will receive iv fluids (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
Inclusion criteria
Exclusion criteria
Ongoing infection(elevated c reactive protein) Venous canula in situ(central or peripheral) No consent
Primary outcome(s)
|
1.
Recovery parameters: •Duration of ICU stay •Duration of hospital stay postoperatively •Morbidity during first 3 months •Mortality within 3 months |
[ Hospital discharge |
|
2.
Health attributes -Functional status -Well being -Overall health |
[ Hospital discharge |
Secondary outcome(s)
|
1.
|
[ Hospital discharge At 3 months ] |
Target number/sample size
60
Countries of recruitment
Sri Lanka
Anticipated start date
2008-06-01
Anticipated end date
2009-06-01
Date of first enrollment
Date of study completion
Recruitment status
Complete: follow up complete
Funding source
University of Peradeniya
Regulatory approvals
Status
Approved
Date of Approval
2006-07-19
Approval number
Not Available
Details of Ethics Review Committee
| Name: | Ethics Review Committee, Faculty of Medicine, University of Peradeniya |
| Institutional Address: | Galaha Road, Kandy, Sri Lanka |
| Telephone: | +94-812396361 |
| Email: | chairpersonierc@gmail.com |
Contact person for Scientific Queries/Principal Investigator
Prof. C.D.A. Goonasekera
Head, Dept. of Anaesthesiology
Faculty of Medicine, University of Peradeniya, Sri Lanka
00940712771507
00940812389106
cgoonase@slt.lk
Contact Person for Public Queries
Prof. C.D.A. Goonasekera
Head, Dept. of Anaesthesiology
Faculty of Medicine, University of Peradeniya.
00940712771507
00940812389106
cgoonase@slt.lk
Primary study sponsor/organization
Faculty of Medicine
University of Peradeniya, Sri Lanka
0812396460
0812389106
cgoonase@slt.lk
Do the investigators plan to share identified individual clinical trial participant-level data (IPD)?
IPD sharing plan description
Not Available
Study protocol available
Protocol version and date
Not Available
Protocol URL
Not Available
Results summary available
No
Date of posting results
Date of study completion
Final sample size
Date of first publication
Link to results
Brief summary of results
