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

20 Jun 2008

The date of last modification

Jan 30, 2019


Trial Status



Application Summary


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


Trial Details


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

  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



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
    At 3 months

    ]
  2. Health attributes -Functional status -Well being -Overall health

    [

    Hospital discharge
    At 3 months

    ]

Secondary outcome(s)

    1. Postoperative complications: • Infection • Reoperation • Comorbidity
    [

    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



State of Ethics Review Approval


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 & Sponsor Information


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

Secondary study sponsor (If any)

None





Trial Completion details


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