- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT07651150
DEX-HIP Trial: Preoperative IV Dexamethasone 4 mg vs Placebo to Reduce Postoperative Delirium Burden in Adults ≥70 Undergoing Hip Fracture Surgery
DEX-HIP Trial: Preoperative IV Dexamethasone 4 mg vs Placebo to Reduce Postoperative Delirium Burden in Adults ≥70 Undergoing Hip Fracture Surgery : a Randomized Double-blind Trial.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
Postoperative delirium (POD) is one of the most frequent and clinically significant complications following hip fracture surgery in older adults. It is associated with prolonged hospitalization, increased postoperative complications, delayed functional recovery, institutionalization, increased healthcare costs, and higher short- and long-term mortality. Despite advances in orthogeriatric care, POD remains highly prevalent among geriatric hip-fracture patients due to the combined effects of advanced age, frailty, baseline cognitive vulnerability, surgical stress, pain, inflammation, metabolic disturbance, and perioperative physiological insults.
Emerging evidence suggests that neuroinflammation plays a central role in the pathophysiology of postoperative delirium. Hip fracture itself initiates a systemic inflammatory response that may be amplified by surgical intervention and postoperative stress. Corticosteroids such as dexamethasone possess potent anti-inflammatory properties and may attenuate inflammatory pathways implicated in delirium development. Previous studies, including the STRIDE feasibility trial and exploratory randomized trials in geriatric fracture populations, have suggested that preoperative dexamethasone may reduce delirium severity and possibly decrease delirium incidence following hip fracture surgery. However, evidence remains limited and inconsistent, and further randomized controlled trials are required to clarify the efficacy and safety of this intervention.
This study was designed as a single-center, prospective, randomized, double-blind, placebo-controlled parallel-group clinical trial conducted at the Department of Orthopaedic Surgery, Jinnah Postgraduate Medical Centre (JPMC), Karachi, Pakistan. The study evaluated whether administration of a single low-dose preoperative intravenous dexamethasone injection (4 mg) could reduce the incidence and severity of postoperative delirium in older adults undergoing surgery for hip fracture.
Eligible participants included adults aged 60 years or older with hip fractures less than three weeks old who were scheduled for operative management and were able to undergo postoperative delirium assessment. Participants were randomly assigned in a 1:1 ratio to receive either intravenous dexamethasone 4 mg or an equivalent volume of normal saline placebo before surgery. Randomization was computer-generated with concealed allocation. Study medications were prepared by personnel not involved in patient care or outcome assessment to maintain blinding of participants, treating clinicians, and outcome assessors.
The primary outcome was the incidence of postoperative delirium within the first five postoperative days or until discharge, assessed using the Confusion Assessment Method (CAM/CAM-ICU). Delirium severity was evaluated using the validated Memorial Delirium Assessment Scale (MDAS). Secondary outcomes included length of hospital stay, postoperative complications, postoperative hyperglycaemia, infection, and readmission.
Type d'étude
Inscription (Réel)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
-
-
Sindh
-
Karachi, Sindh, Pakistan
- JPMC Karachi
-
-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
La description
Inclusion Criteria:
Adults aged 60 years or older Hip fracture less than 3 weeks old Planned for operative management of hip fracture Able to undergo postoperative delirium assessment
Exclusion Criteria:
Systemic corticosteroid use within the previous 30 days Known hypersensitivity or contraindication to dexamethasone Active infection or sepsis Severe immunosuppression Uncontrolled diabetes mellitus Severe hepatic failure Inability to assess delirium reliably
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Quadruple
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: Dexamethasone
Participants received a single preoperative intravenous dose of dexamethasone 4 mg before operative management of hip fracture.
|
A single 4 mg intravenous dose administered preoperatively.
|
|
Comparateur placebo: placebo
Participants received an equivalent volume of normal saline placebo preoperatively.
|
Participants received an equivalent volume of normal saline placebo preoperatively.
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Incidence of postoperative delirium
Délai: Time Frame: Postoperative Day 1 through Postoperative Day 5, or until hospital discharge, whichever occurs first
|
Proportion of participants with postoperative delirium, defined as a positive Confusion Assessment Method or Confusion Assessment Method for the Intensive Care Unit assessment on any postoperative day.Memorial Delirium Assessment Scale, 0 to 30, and higher scores indicate worse delirium severity.
|
Time Frame: Postoperative Day 1 through Postoperative Day 5, or until hospital discharge, whichever occurs first
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Delirium severity
Délai: Postoperative Day 1 through Postoperative Day 5, or until hospital discharge, whichever occurs first
|
Delirium severity measured using the Memorial Delirium Assessment Scale.
The Memorial Delirium Assessment Scale is scored from 0 to 30, with higher scores indicating greater delirium severity/worse outcome.
|
Postoperative Day 1 through Postoperative Day 5, or until hospital discharge, whichever occurs first
|
|
Length of hospital stay
Délai: From date of surgery until date of hospital discharge, assessed up to 30 days
|
Duration of hospitalization after surgery, measured in days, from the date of surgery to the date of hospital discharge.
|
From date of surgery until date of hospital discharge, assessed up to 30 days
|
|
post operative hyperglycaemia
Délai: From study drug or placebo administration through hospital discharge, assessed up to 30 days
|
Proportion of participants with postoperative hyperglycemia after study drug or placebo administration during the index hospitalization.
Postoperative hyperglycemia is defined as at least one postoperative blood glucose value above the prespecified study threshold.
|
From study drug or placebo administration through hospital discharge, assessed up to 30 days
|
Collaborateurs et enquêteurs
Parrainer
Publications et liens utiles
Publications générales
- Smith TO, Cooper A, Peryer G, Griffiths R, Fox C, Cross J. Factors predicting incidence of post-operative delirium in older people following hip fracture surgery: a systematic review and meta-analysis. Int J Geriatr Psychiatry. 2017 Apr;32(4):386-396. doi: 10.1002/gps.4655. Epub 2017 Jan 17.
- Peng G, Guan Z, Hou Y, Gao J, Rao W, Yuan X, Guo J, Huang X, Zhong Z, Lin J. Depicting developing trend and core knowledge of hip fracture research: a bibliometric and visualised analysis. J Orthop Surg Res. 2021 Mar 4;16(1):174. doi: 10.1186/s13018-021-02292-x.
- Tarazona-Santabalbina FJ, Ojeda-Thies C, Figueroa Rodriguez J, Cassinello-Ogea C, Caeiro JR. Orthogeriatric Management: Improvements in Outcomes during Hospital Admission Due to Hip Fracture. Int J Environ Res Public Health. 2021 Mar 16;18(6):3049. doi: 10.3390/ijerph18063049.
- Kluger MT, Skarin M, Collier J, Rice DA, McNair PJ, Seow MY, Connolly MJ. Steroids to reduce the impact on delirium (STRIDE): a double-blind, randomised, placebo-controlled feasibility trial of pre-operative dexamethasone in people with hip fracture. Anaesthesia. 2021 Aug;76(8):1031-1041. doi: 10.1111/anae.15465. Epub 2021 Apr 25.
- Huang JW, Yang YF, Gao XS, Xu ZH. A single preoperative low-dose dexamethasone may reduce the incidence and severity of postoperative delirium in the geriatric intertrochanteric fracture patients with internal fixation surgery: an exploratory analysis of a randomized, placebo-controlled trial. J Orthop Surg Res. 2023 Jun 19;18(1):441. doi: 10.1186/s13018-023-03930-2.
- Yang P, Fan Y, Tang W. Correlation of intraoperative blood pressure variability and postoperative delirium in elderly hip fracture surgery. Sci Rep. 2025 Apr 29;15(1):15007. doi: 10.1038/s41598-025-00019-0.
- Wang F, Hao X, Zhu Y. Effects of perioperative intravenous glucocorticoids on perioperative neurocognitive disorders in adults after surgery: A PRISMA-compliant meta-analysis of randomized controlled trials. Medicine (Baltimore). 2023 Aug 25;102(34):e34708. doi: 10.1097/MD.0000000000034708.
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
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 (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
- Manifestations neurologiques
- Maladies du système nerveux
- Les troubles mentaux
- Complications postopératoires
- Processus pathologiques
- Confusion
- Manifestations neurocomportementales
- Troubles neurocognitifs
- Délire
- Conditions pathologiques, signes et symptômes
- Signes et symptômes
- Délire d'émergence
- Composés polycycliques
- Prégnades
- Grossesse
- Stéroïdes
- Composés à anneau fusionné
- Stéroïdes, fluorés
- Grossissement
- Dexaméthasone
Autres numéros d'identification d'étude
- No.F.2-81/2026-GENL/13/JPMC
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Étudie un produit d'appareil réglementé par la FDA américaine
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .