Tight Caloric Balance in Geriatric Patients (TICACOSiGP)
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.
연구 개요
상세 설명
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.
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Petah Tikva, 이스라엘
- RabinMC
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
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.
공부 계획
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디자인 세부사항
- 주 목적: 지지 요법
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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간섭 없음: Group 2 (Control group)
Group 2(Control group)-patients in this group received nutrition according to the standard hospital dietary regimen.
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실험적: 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.
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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.
다른 이름들:
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Rate of postoperative complications
기간: up to day 14
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incidence of postoperative complications following admission up to day 14/or hospital discharge and length of hospital stay will be evaluated
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up to day 14
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Energy balance
기간: prior to surgery and up to 14 day
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energy intake and calculated energy balance.
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prior to surgery and up to 14 day
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공동 작업자 및 조사자
수사관
- 수석 연구원: Pierre Singer, Professor,MD, RabinMC,Beilinson Hospital
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
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