此页面是自动翻译的,不保证翻译的准确性。请参阅 英文版 对于源文本。

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

2026年6月10日 更新者: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.

研究概览

详细说明

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.

研究类型

介入性

注册 (实际的)

120

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

    • Sindh
      • Karachi、Sindh、巴基斯坦
        • JPMC Karachi

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人
  • 年长者

接受健康志愿者

不

描述

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

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:治疗
  • 分配:随机化
  • 介入模型:并行分配
  • 屏蔽:四人间

武器和干预

参与者组/臂
干预/治疗
实验性的: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.
安慰剂比较:placebo
Participants received an equivalent volume of normal saline placebo preoperatively.
Participants received an equivalent volume of normal saline placebo preoperatively.

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Incidence of postoperative delirium
大体时间: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

次要结果测量

结果测量
措施说明
大体时间
Delirium severity
大体时间: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
大体时间: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
大体时间: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

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

一般刊物

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2026年1月1日

初级完成 (实际的)

2026年3月30日

研究完成 (实际的)

2026年4月15日

研究注册日期

首次提交

2026年6月4日

首先提交符合 QC 标准的

2026年6月10日

首次发布 (实际的)

2026年6月16日

研究记录更新

最后更新发布 (实际的)

2026年6月16日

上次提交的符合 QC 标准的更新

2026年6月10日

最后验证

2026年6月1日

更多信息

与本研究相关的术语

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

未定

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

订阅