Tight Caloric Balance in Geriatric Patients (TICACOSiGP)
The aim of this study to assess the impact of nutritional support guided by repeated measurements of REE in geriatric patients following surgery for hip fractures.
Our hypothesis is that tight caloric control will reduce the risk of significant postoperative complications in geriatric patients following surgery for hip fractures.
Study Design :Prospective, Single center, Randomized, Unblinded study. Study Population:geriatric patients following surgery for hip fractures.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
|Official Title:||Tight Caloric Balance in Geriatric Patients After Hip Fracture.|
- Rate of postoperative complications [ Time Frame: up to day 14 ] [ Designated as safety issue: No ]incidence of postoperative complications following admission up to day 14/or hospital discharge and length of hospital stay will be evaluated
- Energy balance [ Time Frame: prior to surgery and up to 14 day ] [ Designated as safety issue: No ]energy intake and calculated energy balance.
|Study Start Date:||May 2010|
|Study Completion Date:||March 2012|
|Primary Completion Date:||March 2012 (Final data collection date for primary outcome measure)|
No Intervention: Group 2 (Control group)
Group 2(Control group)-patients in this group received nutrition according to the standard hospital dietary regimen.
Experimental: Group 1 (Indirect Calorimetry)
Group 1(Indirect Calorimetry)-The tight calorie group received calories with an energy goal determined by repeated REE measurements using indirect calorimetry.
Other: Indirect Calorimetry
The tight calorie group received calories with an energy goal determined by repeated REE measurements using indirect calorimetry.
IC measurements:after a fasting period of at least 6 hours at three time periods : on admission to the study,between 24-48 hours following surgery and on the 7th day of the study.Measurements were performed by an experienced nurse or dietician,the device was automatically calibrated before each measurement and the REE was recorded after 15 minutes.
Other Name: Energy intake according to REE measurements(nutrition according to the individual energy requirements)
The primary outcome:
presence of postoperative complications,hospital length of stay.
energy intake and calculated energy balance
eligible patients will be randomly assigned to 2 groups: the tight calorie (intervention)group and the control group.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01735435
|Petah Tikva, Israel|
|Principal Investigator:||Pierre Singer, Professor,MD||RabinMC,Beilinson Hospital|