Tight Caloric Balance in Geriatric Patients

NCT01735435 | Completed DMC

• 1 other identifier: 5744
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Nutrition Assessment

Keywords

geriatric patients; nutritional support

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Energy balance

  prior to surgery and up to 14 day

Study Arms (2)

Group 2 (Control group)

NO INTERVENTION

Group 2(Control group)-patients in this group received nutrition according to the standard hospital dietary regimen.

Group 1 (Indirect Calorimetry)

EXPERIMENTAL

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

Interventions

Indirect Calorimetry OTHER

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.

Also known as: Energy intake according to REE measurements(nutrition according to the individual energy requirements)

Group 1 (Indirect Calorimetry)

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Rabin Medical Center: lead

Study Sites (1)

RabinMC

Petah Tikva, Israel

Location

MeSH Terms

Interventions

Calorimetry, Indirect

Intervention Hierarchy (Ancestors)

Calorimetry; Chemistry Techniques, Analytical; Investigative Techniques

Study Officials

• Pierre Singer, Professor,MD

  RabinMC,Beilinson Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor Pierre Singer, MD

Study Record Dates

• First Submitted: November 24, 2012
• First Posted: November 28, 2012
• Study Start: May 1, 2010
• Primary Completion: March 1, 2012
• Study Completion: March 1, 2012
• Last Updated: November 28, 2012

Record last verified: 2012-11

Locations

IL (1)