- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning 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.
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Faktisk)
Fas
- Inte tillämpbar
Kontakter och platser
Studieorter
-
-
Sindh
-
Karachi, Sindh, Pakistan
- JPMC Karachi
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-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Beskrivning
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
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Fyrdubbla
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: Dexamethasone
Participants received a single preoperative intravenous dose of dexamethasone 4 mg before operative management of hip fracture.
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A single 4 mg intravenous dose administered preoperatively.
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Placebo-jämförare: placebo
Participants received an equivalent volume of normal saline placebo preoperatively.
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Participants received an equivalent volume of normal saline placebo preoperatively.
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Incidence of postoperative delirium
Tidsram: 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.
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Time Frame: Postoperative Day 1 through Postoperative Day 5, or until hospital discharge, whichever occurs first
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Delirium severity
Tidsram: 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.
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Postoperative Day 1 through Postoperative Day 5, or until hospital discharge, whichever occurs first
|
|
Length of hospital stay
Tidsram: 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.
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From date of surgery until date of hospital discharge, assessed up to 30 days
|
|
post operative hyperglycaemia
Tidsram: 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
|
Samarbetspartners och utredare
Publikationer och användbara länkar
Allmänna publikationer
- 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.
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
- Neurologiska manifestationer
- Sjukdomar i nervsystemet
- Mentala störningar
- Postoperativa komplikationer
- Patologiska processer
- Förvirring
- Neurobehavioral manifestationer
- Neurokognitiva störningar
- Delirium
- Patologiska tillstånd, tecken och symtom
- Tecken och symtom
- Emergence Delirium
- Polycykliska föreningar
- Graviditet
- Graviditet
- Steroider
- Fusion-ringföreningar
- Steroider, fluorerade
- Graviditet
- Dexametason
Andra studie-ID-nummer
- No.F.2-81/2026-GENL/13/JPMC
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