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DEX-HIP Trial: Preoperative IV Dexamethasone 4 mg vs Placebo to Reduce Postoperative Delirium Burden in Adults ≥70 Undergoing Hip Fracture Surgery

10. juni 2026 opdateret af: Jinnah Postgraduate Medical Centre

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.

This single-center, prospective, randomized, double-blind, placebo-controlled trial was conducted at the Department of Orthopaedic Surgery, JPMC, Karachi. Patients aged ≥60 years with hip fractures were randomized 1:1 to receive either intravenous dexamethasone or a placebo preoperatively. The primary outcome was the incidence of POD within the first five postoperative days or until discharge, assessed via the Confusion Assessment Method. Delirium severity was quantified using the validated Memorial Delirium Assessment Scale.

Studieoversigt

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

120

Fase

  • Ikke anvendelig

Kontakter og lokationer

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Studiesteder

    • Sindh
      • Karachi, Sindh, Pakistan
        • JPMC Karachi

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

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

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Firedobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: 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.
Placebo komparator: placebo
Participants received an equivalent volume of normal saline placebo preoperatively.
Participants received an equivalent volume of normal saline placebo preoperatively.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Incidence of postoperative delirium
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Delirium severity
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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

Samarbejdspartnere og efterforskere

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Publikationer og nyttige links

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Generelle publikationer

Datoer for undersøgelser

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Studer store datoer

Studiestart (Faktiske)

1. januar 2026

Primær færdiggørelse (Faktiske)

30. marts 2026

Studieafslutning (Faktiske)

15. april 2026

Datoer for studieregistrering

Først indsendt

4. juni 2026

Først indsendt, der opfyldte QC-kriterier

10. juni 2026

Først opslået (Faktiske)

16. juni 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

16. juni 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

10. juni 2026

Sidst verificeret

1. juni 2026

Mere information

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