Systematic Ultrasound Screening for Lower Extremity Deep Vein Thrombosis in ICU Patients with Severe COVID-19: A Randomized Clinical Trial.

IF 3 3区医学 Q2 CRITICAL CARE MEDICINE

Journal of Intensive Care Medicine Pub Date : 2025-01-22 DOI:10.1177/08850666251313774

Carlos Ernesto Marrero Eligio De La Puente, David Flota Ruiz, Lluis Sánchez Besalduch, Xavier Faner Capó, Daniel Gil Sala, Clara Palmada Ibars, Ivan Bajaña Mindiolaza, Luis Silvestre Chiscano Camon, Adolfo Ruiz Sanmartin, Juan Carlos Ruiz-Rodríguez, Ricard Ferrer, Sergi Bellmunt Montoya

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引用次数: 0

Abstract

Background: Venous thromboembolism (VTE), whether pulmonary embolism (PE) or deep vein thrombosis (DVT), is common in patients with COVID-19. Recommendations on systematic screening in the intensive care unit (ICU) are lacking.

Research question: Is there any clinical benefit of systematic screening for DVT in critically ill patients with severe COVID-19?

Study design and methods: Single-center randomized clinical trial (RCT) of COVID-19 cases admitted to the ICU. Patients were randomized into two groups: a study group that underwent ultrasound (US) screening for DVT Mondays and Thursdays, and a control group that was treated according to the unit protocol. The primary outcome was the presence of DVT. Secondary outcomes were ICU total stay, death within 21-day follow-up and bleeding complications (minor or major). A composite outcome of poor prognosis variables was analyzed. We tested a superiority hypothesis with a confidence level of 95% and an equivalence limit of 20%.

Results: 163 patients (84 screening group, 79 control group) were enrolled between April and July 2021. There were 90 men (55.2%) with a mean ± SD age of 49.8 ± 13.58 years. In screening group 16.7% developed DVT versus 3.8% in control group (p = .007), and 3.6% versus 5.1% developed PE, respectively (p = 0.7). Poor outcome variables were male sex, age, COVID-19 vaccination status, Fibrinogen, Urea, Creatinine and Interleukin 6 (IL6) levels; Acute Physiology and Chronic Health Evaluation II (APACHE II) and Sequential Organ Failure Assessment (SOFA) scales. The superiority comparison, with a power of 95%, showed no statistically significant differences for a composite endpoint (p = .123). After adjusting by group, the OR for poor outcome is 1.966 (0.761-5.081) p = 0.163.

Interpretation: Among these patients, a strategy of systematic US screening for DVT was not associated with any significant improvements to clinical outcomes compared with usual care.

Clinical trial registration: Clinicaltrials.org registration number: NCT05028244.

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系统超声筛查重症COVID-19患者下肢深静脉血栓：一项随机临床试验

背景：静脉血栓栓塞（VTE），无论是肺栓塞（PE）还是深静脉血栓形成（DVT），在COVID-19患者中都很常见。目前缺乏关于重症监护病房（ICU）系统筛查的建议。研究问题：对重症COVID-19危重患者进行系统筛查DVT是否有临床益处？研究设计和方法：采用单中心随机临床试验（RCT）对ICU收治的COVID-19病例进行研究。患者被随机分为两组：研究组在周一和周四接受深静脉血栓超声筛查，对照组根据单位方案进行治疗。主要结果是是否存在深静脉血栓。次要结局为ICU总住院时间、随访21天内死亡和出血并发症（轻微或严重）。对不良预后变量的综合结果进行分析。我们以95%的置信水平和20%的等效限检验了优势假设。结果：2021年4月至7月共纳入163例患者，其中筛查组84例，对照组79例。男性90例（55.2%），平均±SD年龄49.8±13.58岁。在筛查组中，16.7%的患者发生DVT，对照组为3.8% (p = 0.007)， 3.6%的患者发生PE，对照组为5.1% （p = 0.7）。不良结局变量为男性、年龄、COVID-19疫苗接种情况、纤维蛋白原、尿素、肌酐和白细胞介素6 （IL6）水平；急性生理和慢性健康评估II （APACHE II）和顺序器官衰竭评估（SOFA）量表。优势比较为95%，显示复合终点无统计学显著差异（p = .123）。分组调整后，不良预后OR为1.966 (0.761-5.081)p = 0.163。解释：在这些患者中，与常规护理相比，系统的美国深静脉血栓筛查策略与临床结果的任何显著改善无关。临床试验注册：Clinicaltrials.org注册号：NCT05028244。

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来源期刊

Journal of Intensive Care Medicine CRITICAL CARE MEDICINE-

CiteScore

7.60

自引率

3.20%

发文量

107

期刊介绍： Journal of Intensive Care Medicine (JIC) is a peer-reviewed bi-monthly journal offering medical and surgical clinicians in adult and pediatric intensive care state-of-the-art, broad-based analytic reviews and updates, original articles, reports of large clinical series, techniques and procedures, topic-specific electronic resources, book reviews, and editorials on all aspects of intensive/critical/coronary care.