Tight Caloric Balance in Geriatric Patients

Study Overview
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Brief Summary
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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.

Detailed Description
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The primary outcome: presence of postoperative complications,hospital length of stay. Secondary outcomes: energy intake and calculated energy balance Study Procedure: eligible patients will be randomly assigned to 2 groups: the tight calorie (intervention)group and the control group.

Official Title
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Tight Caloric Balance in Geriatric Patients After Hip Fracture.

Conditions
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Nutrition Assessment

Intervention / Treatment
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* Other: Indirect Calorimetry


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patients older than 65 years who were admitted to the unit following hip fracture within 48 hours of the injury and in whom orthopedic surgery was considered the treatment of choice. Exclusion Criteria: Patients were excluded if they presented to hospital > 48 hours after the injury, were receiving steroids and/or immunosuppression therapy; in the presence of active oncologic disease, multiple fractures, diagnosed dementia or in the event that patients required supplemental nasal oxygen which precludes the measurement of resting energy expenditure.

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Group 2 (Control group)<br>Group 2(Control group)-patients in this group received nutrition according to the standard hospital dietary regimen. | |
| Experimental: Group 1 (Indirect Calorimetry)<br>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<br>* 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.<br>* Other names: Energy intake according to REE measurements(nutrition according to the individual energy requirements);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of postoperative complications | incidence of postoperative complications following admission up to day 14/or hospital discharge and length of hospital stay will be evaluated | up to day 14 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Energy balance | energy intake and calculated energy balance. | prior to surgery and up to 14 day | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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geriatric patients, nutritional support