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Tight Caloric Balance in Geriatric Patients (TICACOSiGP)

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ClinicalTrials.gov Identifier: NCT01735435
Recruitment Status : Completed
First Posted : November 28, 2012
Last Update Posted : November 28, 2012
Sponsor:
Information provided by (Responsible Party):

Study Description
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.


Condition or disease Intervention/treatment
Nutrition Assessment Other: Indirect Calorimetry

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 Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Tight Caloric Balance in Geriatric Patients After Hip Fracture.
Study Start Date : May 2010
Primary Completion Date : March 2012
Study Completion Date : March 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
No Intervention: Group 2 (Control group)
Group 2(Control group)-patients in this group received nutrition according to the standard hospital dietary regimen.
Experimental: 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.
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.

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


Outcome Measures

Primary Outcome Measures :
  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 Outcome Measures :
  1. Energy balance [ Time Frame: prior to surgery and up to 14 day ]
    energy intake and calculated energy balance.


Eligibility Criteria

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Ages Eligible for Study:   65 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Contacts and Locations

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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01735435


Locations
Israel
RabinMC
Petah Tikva, Israel
Sponsors and Collaborators
Rabin Medical Center
Investigators
Principal Investigator: Pierre Singer, Professor,MD RabinMC,Beilinson Hospital
More Information

Responsible Party: Pierre singer, Professor Pierre Singer, MD, Rabin Medical Center
ClinicalTrials.gov Identifier: NCT01735435     History of Changes
Other Study ID Numbers: 5744
First Posted: November 28, 2012    Key Record Dates
Last Update Posted: November 28, 2012
Last Verified: November 2012

Keywords provided by Pierre singer, Rabin Medical Center:
geriatric patients
nutritional support