Nutrition AssessmentTICACOSiGPNCT01735435
Tight Caloric Balance in Geriatric Patients
A study testing Indirect Calorimetry in people with Nutrition Assessment, run by Rabin Medical Center at 1 site in Israel.
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… Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Nutrition Assessment
- What is being tested?
- Indirect Calorimetry
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteIsrael
- Study dates
- May 2010to Mar 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Tight Caloric Balance in Geriatric Patients After Hip Fracture.
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.
Read the 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.
- Conditions
- Nutrition Assessment
- Being tested
- Indirect Calorimetry
- Keywords
- geriatric patients, nutritional support
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Indirect CalorimetryOther
Also called Energy intake according to REE measurements(nutrition according to the individual energy requirements)
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Indirect Calorimetry |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: up to day 14
Secondary outcomes (1)
Energy balance
energy intake and calculated energy balance.
Measured: prior to surgery and up to 14 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Nov 2012 (estimated)
- Study startMay 2010
- Primary completionMar 2012
- Study completionMar 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nutrition AssessmentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rabin Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pierre singer, Rabin Medical Center
- Investigators
- Pierre Singer, Professor,MD, Principal investigator, RabinMC,Beilinson Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01735435
- Sponsor's protocol ID
- 5744
- Acronym
- TICACOSiGP
- Status last verified
- Nov 2012
- First submitted
- 24 Nov 2012
- Last updated
- 28 Nov 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tight Caloric Balance in Geriatric Patients After Hip Fracture.
- ClinicalTrials.gov ID
- NCT01735435
- Acronym / sponsor ID
- TICACOSiGP / 5744
- Conditions
- Nutrition Assessment
- Keywords
- geriatric patients, nutritional support
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Rabin Medical CenterUniversity, hospital or other
- Study start
- May 2010
- Primary completion
- Mar 2012 (actual)
- Study completion
- Mar 2012 (actual)
- First posted
- 28 Nov 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 | Other: Indirect CalorimetryGroup 1(Indirect Calorimetry)-The tight calorie group received calories with an energy goal determined by repeated REE measurements using indirect calorimetry. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Indirect CalorimetryAlso: Energy intake according to REE measurements(nutrition according to the individual energy requirements)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 | Group 1 (Indirect Calorimetry) |
Primary outcome
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
1 secondary outcome
Energy balance
Time frame: prior to surgery and up to 14 day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Nov 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pierre Singer, Professor,MD principal investigator
RabinMC,Beilinson Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Indirect Calorimetry in people with Nutrition Assessment, run by Rabin Medical Center at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Nov 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of postoperative complications (time frame: up to day 14). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Nov 2012.