Tight Caloric Balance in Geriatric Patients

Nutrition Assessment Clinical Trial

— TICACOSiGP  

Official title:

Tight Caloric Balance in Geriatric Patients After Hip Fracture.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01735435
• Other study ID #: 5744
• Status: Completed
• Phase: N/A
• First received: November 24, 2012
• Last updated: November 27, 2012
• Start date: May 2010
• Est. completion date: March 2012

Study information

• Verified date: November 2012
• Source: Rabin Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Ethics Commission
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: March 2012
• Est. primary completion date: March 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 65 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Nutrition Assessment

Intervention

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.

Locations

Country	Name	City	State
Israel	RabinMC	Petah Tikva

Sponsors (1)

Lead Sponsor	Collaborator
Rabin Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Energy balance	energy intake and calculated energy balance.	prior to surgery and up to 14 day	No