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.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Inscription (Réel)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
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Petah Tikva, Israël
- RabinMC
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
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.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Soins de soutien
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
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Aucune intervention: 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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Expérimental: 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.
Autres noms:
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Rate of postoperative complications
Délai: 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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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Energy balance
Délai: 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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Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Pierre Singer, Professor,MD, RabinMC,Beilinson Hospital
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Autres numéros d'identification d'étude
- 5744
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