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OpenTrials
Completed

NCT Number: NCT01735435

Tight Caloric Balance in Geriatric Patients

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.

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Key information

Conditions

Nutrition Assessment

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

RabinMC

Petah Tikva, Israel

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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

Primary outcomes

  1. Rate of postoperative complications

    Time frame: 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 outcomes

  1. Energy balance

    Time frame: prior to surgery and up to 14 day

    energy intake and calculated energy balance.

Sponsors and collaborators

Lead sponsor

Rabin Medical Center

Other

Registry information

Official study title

Tight Caloric Balance in Geriatric Patients After Hip Fracture.

Acronym: TICACOSiGP

Important dates

Study start
2010
Primary completion
2012
Study completion
2012
First posted
Nov 28, 2012
Registry last updated
Nov 28, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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