Tight Caloric Balance in Geriatric Patients

Not Applicable

Completed

• Conditions: Nutrition Assessment
• Interventions: Other: Indirect Calorimetry

• Registration Number: NCT01735435
• Lead Sponsor: Rabin Medical Center

Brief Summary

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

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.

Study Timeline

• Study Start: 2010-05
• Primary Completion: 2012-03
• Study Completion: 2012-03
• Status Verified: 2012-11
• Study First Submitted: 2012-11-24
• Study First Submitted QC: 2012-11-27
• Last Update Submitted: 2012-11-27
• Study First Posted: 2012-11-28
• Last Update Posted: 2012-11-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 1 (Indirect Calorimetry)	Indirect Calorimetry	Group 1(Indirect Calorimetry)-The tight calorie group received calories with an energy goal determined by repeated REE measurements using indirect calorimetry.

Primary Outcome Measures

Name	Time	Method
Rate of postoperative complications	up to day 14	incidence of postoperative complications following admission up to day 14/or hospital discharge and length of hospital stay will be evaluated

Secondary Outcome Measures

Name	Time	Method
Energy balance	prior to surgery and up to 14 day	energy intake and calculated energy balance.

Trial Locations

Locations (1)

RabinMC; 🇮🇱 Petah Tikva, Israel