成人心脏手术围术期右美托咪定与30天预后
2026年9月9日 更新者:China Medical University Hospital
围术期右美托咪定与成人心脏手术后30天结局:基于TriNetX网络的真实世界回顾性队列研究
这项观察性研究使用来自TriNetX全球协作网络(2010年1月1日至2025年7月1日)的去标识化电子健康记录数据,旨在检验围术期右美托咪定(DEX)是否与成人心脏手术后30天预后相关。
纳入年龄18-100岁、接受首次冠状动脉旁路移植术或心脏瓣膜手术的成人患者。
暴露定义为从索引手术前24小时至术后48小时内的任何DEX给药;对照组在此时间窗口内未接受DEX。
主要结局是30天内谵妄发生率。
次要结局包括30天全因死亡率、急性肾损伤、肺炎、败血症、红细胞输注/大出血、心肌梗死、缺血性卒中/短暂性脑缺血发作、心房颤动、机械通气>96小时(第4-30天)及30天再入院率(第1-30天)。
研究者未分配任何治疗方案,且未使用可识别信息。
研究结果旨在为常规心脏手术护理中的围术期镇静策略提供参考。
研究概览
地位
完全的
详细说明
这是一项使用TriNetX全球协作网络(2010-01-01至2025-07-01)去标识化数据的回顾性队列研究。
将识别年龄在18-100岁之间接受首次冠状动脉旁路移植术或心脏瓣膜手术的成年人。
围手术期暴露定义为从索引手术前24小时至术后48小时内的任何右美托咪定给药;比较队列由在此时间窗口内未使用右美托咪定的患者组成。
术后30天内的临床结局包括以谵妄为主要结局,以及一系列重大术后并发症和死亡率。
将使用基于人口统计学、合并症、基线药物和实验室检查的倾向评分在暴露组之间进行匹配或调整,并使用标准化均差评估平衡性。
时间-事件分析将使用Cox比例风险模型和Kaplan-Meier曲线,并使用Benjamini-Hochberg错误发现率控制多重性。
所有分析仅使用TriNetX平台内的去标识化数据,不与患者直接接触或访问标识符。
研究类型
观察性的
注册 (实际的)
343112
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
-
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Taichung City
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Taichung、Taichung City、台湾、40447
- China Medical University Hospital
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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
取样方法
非概率样本
研究人群
来自TriNetX全球协作网络(2010-01-01至2025-07-01)中接受首次冠状动脉旁路移植术或瓣膜手术的18-100岁成人;去标识化的电子健康记录数据;暴露定义为围术期使用右美托咪定(-24至+48小时);比较组在该时间窗内未使用右美托咪定。
描述
纳入标准:
- 年龄18-100岁。
- 在TriNetX数据库中2010-01-01至2025-07-01期间首次接受冠状动脉旁路移植术或心脏瓣膜手术。
- 具备≥90天术前可观察数据和30天术后观察窗口(术后≤30天内死亡计为完整数据)。
- 可通过标准化平台代码/字段识别索引手术、暴露窗口(-24至+48小时)及结局指标。
排除标准:
- 索引手术前90天内存在终末期肾病或接受透析治疗(ICD-10-CM编码:N18.6、Z49、Z99.2)。
- 非同一住院期间首次接受冠状动脉旁路移植术/瓣膜手术。
- 缺失必要字段或存在冲突记录导致无法明确定义唯一病例。
- 无法在平台内确认暴露窗口或结局指标。
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
队列和干预
团体/队列 |
干预/治疗 |
|---|---|
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Dexmedetomidine medication record present
Eligible patients with a qualifying CABG-coded procedure and any RxNorm 48937 dexmedetomidine medication record on the preceding calendar day or the procedure day (days -1 through 0).
The same medication-record definition is used in the separately constructed exploratory valve-coded population relative to its own qualifying procedure.
Exposure is observed in routine records and is not assigned by investigators.
Administration, dose and intraday timing are not confirmed.
The CABG-coded and valve-coded populations may overlap and are reported separately.
|
An observed dexmedetomidine medication record (RxNorm 48937) on the calendar day before or the day of the index procedure.
No drug, dose, route or regimen is assigned by the study.
This entry describes the record used for exposure classification, not a study intervention.
其他名称:
|
|
Dexmedetomidine medication record absent
The corresponding eligible CABG-coded or separately constructed valve-coded population with no RxNorm 48937 dexmedetomidine medication record during days -1 through 0 relative to its qualifying index procedure.
Dexmedetomidine records outside this window, including later postoperative use, are permitted.
Absence of a record does not establish non-administration or identify an alternative sedative regimen.
The two procedure populations have separate eligibility and matching and may contain overlapping patients.
|
Absence of a dexmedetomidine medication record during days -1 through 0 relative to the index procedure.
Other care is not assigned or standardised by the investigators.
Dexmedetomidine records outside the specified window are allowed.
|
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 |
|---|---|---|
|
First recorded code-defined delirium or disorientation during days 1-30 after the index procedure
大体时间:Day 1 through Day 30 after the index procedure
|
Time to the first qualifying ICD-10-CM R41.0 or F05 record within the window.
R41.0 includes disorientation; this is a code-defined outcome without bedside delirium assessment or individual adjudication.
The CABG-coded population is primary and the valve-coded population exploratory.
Patients with either code on or before day 0 in all available history are excluded before matching.
The outcome-level prior-window exclusion is OFF.
Analysis uses the two-sided log-rank test, Kaplan-Meier window-end failure estimates and complementary hazard ratios, subject to the documented censoring and proportionality limitations.
The day-1 start is not a verified survival landmark.
|
Day 1 through Day 30 after the index procedure
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
All-cause mortality during days 0-30 after the index procedure
大体时间:Day 0 through Day 30 after the index procedure
|
Time to a dated death record using the TriNetX Deceased outcome.
Death is the event for this endpoint.
The data are not assumed to constitute a complete national death registry.
Outcome-level prior-window exclusion is OFF.
This is one of the eight inferential secondary endpoints in the CABG population.
|
Day 0 through Day 30 after the index procedure
|
|
Code-defined acute kidney injury during days 0-30
大体时间:Day 0 through Day 30 after the index procedure
|
Time to the first qualifying ICD-10-CM N17 record, including applicable descendant codes, within the window.
No endpoint-specific exclusion of prior N17 records is applied; this describes a recorded outcome, not necessarily newly occurring disease.
Dialysis codes are not treated as acute kidney injury.
This replaces the earlier acute-kidney-injury/dialysis composite and is one of the eight inferential secondary endpoints.
|
Day 0 through Day 30 after the index procedure
|
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Code-defined pneumonia during days 0-30
大体时间:Day 0 through Day 30 after the index procedure
|
Time to the first qualifying record of ICD-10-CM J13, J14, J15, J16, J17 or J18, or ICD-9-CM 483, within the window.
No endpoint-specific exclusion of prior pneumonia records is applied.
The outcome does not establish microbiological confirmation or newly occurring disease.
This is one of the eight inferential secondary endpoints.
|
Day 0 through Day 30 after the index procedure
|
|
Code-defined sepsis during days 0-30
大体时间:Day 0 through Day 30 after the index procedure
|
Time to the first qualifying ICD-10-CM A40 or A41 record within the window.
No endpoint-specific exclusion of prior sepsis records is applied.
This is a recorded-code outcome, not necessarily newly occurring sepsis, and is one of the eight inferential secondary endpoints.
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Day 0 through Day 30 after the index procedure
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Blood transfusion, haemorrhage-related diagnosis or thoracic exploration code during days 0-30
大体时间:Day 0 through Day 30 after the index procedure
|
Any qualifying ICD-10-CM I97.410, I97.411, I97.610, I97.611 or D62 record, or SNOMED CT 116863004, 288170000, 301842006, 175190002, 26337002 or 77202008 record, during the analysis window, without endpoint-specific exclusion of prior qualifying records.
The retained components include blood transfusion, haemorrhage-related diagnoses and thoracic, pericardial or mediastinal exploration.
Exploration codes do not establish bleeding, a postoperative indication or re-operation.
This heterogeneous code-defined composite is not major bleeding and does not establish an adjudicated bleeding severity grade.
CPT 35820 is not included.
This is one of the eight inferential secondary endpoints in the primary CABG comparison.
|
Day 0 through Day 30 after the index procedure
|
|
Code-defined myocardial infarction during days 0-30
大体时间:Day 0 through Day 30 after the index procedure
|
Time to the first qualifying ICD-10-CM I21 or I22 record within the window.
No endpoint-specific exclusion of prior myocardial infarction records is applied.
This is a recorded-code outcome, not necessarily a new myocardial infarction, and is one of the eight inferential secondary endpoints.
|
Day 0 through Day 30 after the index procedure
|
|
Code-defined ischaemic stroke or transient ischaemic attack during days 0-30
大体时间:Day 0 through Day 30 after the index procedure
|
Time to the first qualifying ICD-10-CM I63 or G45 record within the window.
No endpoint-specific exclusion of prior stroke or transient ischaemic attack records is applied.
This is a recorded-code outcome, not necessarily newly occurring disease, and is one of the eight inferential secondary endpoints.
|
Day 0 through Day 30 after the index procedure
|
|
Code-defined atrial fibrillation during days 0-30
大体时间:Day 0 through Day 30 after the index procedure
|
Time to the first qualifying ICD-10-CM I48.0, I48.1 or I48.91 record within the window.
No endpoint-specific exclusion of prior atrial fibrillation records is applied.
The definition is limited to this specified code set and does not establish new-onset atrial fibrillation.
This is one of the eight inferential secondary endpoints.
|
Day 0 through Day 30 after the index procedure
|
|
Proportion of patients with respiratory ventilation coded as greater than 96 consecutive hours
大体时间:Day 0 through Day 30 after the index procedure
|
Number and proportion of patients with at least one ICD-10-PCS 5A1955Z record during days 0-30.
The code denotes respiratory ventilation greater than 96 consecutive hours, but its recorded date does not establish intubation onset or when 96 hours was reached.
This explicitly replaces the previously registered days 4-30 window.
Use this outcome batch's analysed denominator; prior-window exclusion is OFF.
This is a descriptive recorded-code proportion, not a censoring-adjusted risk.
No ventilation Kaplan-Meier or Cox analysis is performed.
Comparative statistics generated automatically with the native patient-count output are preserved but are not interpreted as inferential study results or included in multiplicity adjustment.
|
Day 0 through Day 30 after the index procedure
|
其他结果措施
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Proportion of patients with a recorded inpatient or observation encounter during days 1-30
大体时间:Day 1 through Day 30 after the index procedure
|
Number and proportion of patients with at least one inpatient encounter flag (HL7 v3 Visit Type IMP) or a record under CPT grouping 1013659, Hospital Inpatient and Observation Care Services, within the window.
Discharge followed by a new admission is not required, so this replaces the earlier readmission label.
Use this measure's own batch denominator; prior-encounter exclusion is OFF.
Count patients, not encounter instances.
Automatically generated comparative statistics are preserved as technical outputs but are not interpreted as inferential results or included in multiplicity adjustment.
|
Day 1 through Day 30 after the index procedure
|
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F05-only recorded delirium during days 1-30: sensitivity analysis
大体时间:Day 1 through Day 30 after the index procedure
|
Time to the first qualifying ICD-10-CM F05 record within the window, as an exploratory sensitivity analysis of the primary R41.0-or-F05 definition.
Retain the broader exclusion of any R41.0 or F05 record on or before day 0 in all available history, applied before matching.
Outcome-level prior-window exclusion is OFF.
The CABG sensitivity endpoint was specified and run alongside the revised primary endpoint on 5 September 2026.
It is outside the eight-test secondary multiplicity family; its addition to this registry amendment does not imply prospective registration of that run.
|
Day 1 through Day 30 after the index procedure
|
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。
调查人员
- 首席研究员:En-Bo Wu, MD、Department of Anesthesiology, China Medical University Hospital, Taichung City, Taiwan
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
- Poon WH, Ling RR, Yang IX, Luo H, Kofidis T, MacLaren G, Tham C, Teoh KLK, Ramanathan K. Dexmedetomidine for adult cardiac surgery: a systematic review, meta-analysis and trial sequential analysis. Anaesthesia. 2023 Mar;78(3):371-380. doi: 10.1111/anae.15947. Epub 2022 Dec 19.
- Caetano da Silva L, Tapioca V, Viana P, Pereira EM, Gibicoski T, Amaral S. Dexmedetomidine for delirium prevention after cardiac surgery: An updated systematic review and meta-analysis with trial sequential analysis. Anaesth Crit Care Pain Med. 2025 Sep;44(5):101578. doi: 10.1016/j.accpm.2025.101578. Epub 2025 Jun 24.
- Wang HB, Jia Y, Zhang CB, Zhang L, Li YN, Ding J, Wu X, Zhang Z, Wang JH, Wang Y, Yan FX, Yuan S, Sessler DI. A randomised controlled trial of dexmedetomidine for delirium in adults undergoing heart valve surgery. Anaesthesia. 2023 May;78(5):571-576. doi: 10.1111/anae.15983. Epub 2023 Feb 16.
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)
2010年1月1日
初级完成 (实际的)
2025年7月31日
研究完成 (实际的)
2025年7月31日
研究注册日期
首次提交
2025年11月17日
首先提交符合 QC 标准的
2025年11月24日
首次发布 (实际的)
2025年11月25日
研究记录更新
最后更新发布 (实际的)
2026年9月11日
上次提交的符合 QC 标准的更新
2026年9月9日
最后验证
2026年9月1日
更多信息
与本研究相关的术语
其他相关的 MeSH 术语
其他研究编号
- CMUH114-REC3-181
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)?
不
IPD 计划说明
这项回顾性观察研究使用来自TriNetX全球协作网络的去标识化数据。
研究者不会收到可识别信息或重新识别密钥。
与TriNetX及参与医疗组织签订的数据使用协议禁止在平台外共享或重新分发行级个体参与者数据。
仅共享汇总结果和模型估计(例如表格、图表);研究文件和统计分析代码可根据合理请求提供。
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.