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开发和验证了一个多变量预测模型,用于预测五个随机试验队列中心静脉导管尖端定植。

Development and validation of a multivariable prediction model of central venous catheter-tip colonization in a cohort of five randomized trials.

机构信息

Department of Clinical Research and Biostatistics, Caen University Hospital and Caen Normandy University, Caen, France.

INSERM U1311 DynaMicURe, Caen Normandy University, Caen, France.

出版信息

Crit Care. 2022 Jul 7;26(1):205. doi: 10.1186/s13054-022-04078-x.

Abstract

BACKGROUND

The majority of central venous catheters (CVC) removed in the ICU are not colonized, including when a catheter-related infection (CRI) is suspected. We developed and validated a predictive score to reduce unnecessary CVC removal.

METHODS

We conducted a retrospective cohort study from five multicenter randomized controlled trials with systematic catheter-tip culture of consecutive CVCs. Colonization was defined as growth of ≥10 colony-forming units per mL. Risk factors for colonization were identified in the training cohort (CATHEDIA and 3SITES trials; 3899 CVCs of which 575 (15%) were colonized) through multivariable analyses. After internal validation in 500 bootstrapped samples, the CVC-OUT score was computed by attaching points to the robust (> 50% of the bootstraps) risk factors. External validation was performed in the testing cohort (CLEAN, DRESSING2 and ELVIS trials; 6848 CVCs, of which 588 (9%) were colonized).

RESULTS

In the training cohort, obesity (1 point), diabetes (1 point), type of CVC (dialysis catheter, 1 point), anatomical insertion site (jugular, 4 points; femoral 5 points), rank of the catheter (second or subsequent, 1 point) and catheterization duration (≥ 5 days, 2 points) were significantly and independently associated with colonization . Area under the ROC curve (AUC) for the CVC-OUT score was 0.69, 95% confidence interval (CI) [0.67-0.72]. In the testing cohort, AUC for the CVC-OUT score was 0.60, 95% CI [0.58-0.62]. Among 1,469 CVCs removed for suspected CRI in the overall population, 1200 (82%) were not colonized. The negative predictive value (NPV) of a CVC-OUT score < 6 points was 94%, 95% CI [93%-95%].

CONCLUSION

The CVC-OUT score had a moderate ability to discriminate catheter-tip colonization, but the high NPV may contribute to reduce unnecessary CVCs removal. Preference of the subclavian site is the strongest and only modifiable risk factor that reduces the likelihood of catheter-tip colonization and consequently the risk of CRI.

CLINICAL TRIALS REGISTRATION

NCT00277888, NCT01479153, NCT01629550, NCT01189682, NCT00875069.

摘要

背景

在 ICU 中,大多数被移除的中心静脉导管(CVC)并未被定植,即使怀疑发生导管相关性感染(CRI)也是如此。我们开发并验证了一种预测评分系统,以减少不必要的 CVC 移除。

方法

我们进行了一项回顾性队列研究,纳入了五项多中心随机对照试验中连续进行的系统导管尖端培养的 CVC。定植定义为每毫升生长≥10 个菌落形成单位。通过多变量分析在训练队列(CATHEDIA 和 3SITES 试验;3899 个 CVC 中有 575 个[15%]被定植)中确定了定植的危险因素。在 500 个 bootstrap 样本的内部验证后,通过为稳健(>50%的 bootstrap)危险因素赋值,计算 CVC-OUT 评分。在外部验证队列(CLEAN、DRESSING2 和 ELVIS 试验;6848 个 CVC 中有 588 个[9%]被定植)中进行了外部验证。

结果

在训练队列中,肥胖(1 分)、糖尿病(1 分)、CVC 类型(透析导管,1 分)、解剖插入部位(颈内静脉,4 分;股静脉,5 分)、导管等级(第 2 级或更高级别,1 分)和导管留置时间(≥5 天,2 分)与定植显著且独立相关。CVC-OUT 评分的受试者工作特征曲线下面积(AUC)为 0.69,95%置信区间(CI)[0.67-0.72]。在验证队列中,CVC-OUT 评分的 AUC 为 0.60,95%CI[0.58-0.62]。在整个人群中,因疑似 CRI 而移除的 1469 个 CVC 中,有 1200 个(82%)未被定植。CVC-OUT 评分<6 分的阴性预测值(NPV)为 94%,95%CI[93%-95%]。

结论

CVC-OUT 评分能够较好地区分导管尖端定植,但高 NPV 可能有助于减少不必要的 CVC 移除。首选锁骨下部位是唯一可改变的最强危险因素,可降低导管尖端定植的可能性,从而降低 CRI 的风险。

临床试验注册

NCT00277888、NCT01479153、NCT01629550、NCT01189682、NCT00875069。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/41e7/9261073/7ba2de01c46d/13054_2022_4078_Fig1_HTML.jpg

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