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Tight Caloric Balance in Geriatric Patients

NCT ID: NCT01735435

Last Updated: 2012-11-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-05-31

Study Completion Date

2012-03-31

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.

Conditions

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Nutrition Assessment

Keywords

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geriatric patients nutritional support

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Group 2 (Control group)

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

Group Type NO_INTERVENTION

No interventions assigned to this group

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.

Group Type EXPERIMENTAL

Indirect Calorimetry

Intervention Type 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.

Interventions

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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.

Intervention Type OTHER

Other Intervention Names

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Energy intake according to REE measurements(nutrition according to the individual energy requirements)

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.
Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Rabin Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Pierre singer

Professor Pierre Singer, MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Pierre Singer, Professor,MD

Role: PRINCIPAL_INVESTIGATOR

RabinMC,Beilinson Hospital

Locations

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RabinMC

Petah Tikva, , Israel

Site Status

Countries

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Israel

Other Identifiers

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5744

Identifier Type: -

Identifier Source: org_study_id