降钙素原指导下的危重症癌症合并脓毒症患者的抗生素管理和疗程（Pro-Can 研究）：一项随机对照试验。

Procalcitonin-Guided Management and Duration of Antibiotic Therapy in Critically Ill Cancer Patients With Sepsis (Pro-Can Study): A Randomized Controlled Trial.

机构信息

King Hussein Cancer Center, Amman, Jordan.

School of Clinical Sciences, Monash University, Melbourne, VIC, Australia.

出版信息

Crit Care Explor. 2024 Oct 21;6(10):e1173. doi: 10.1097/CCE.0000000000001173. eCollection 2024 Oct 1.

DOI:10.1097/CCE.0000000000001173

PMID:39431961

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC11495690/

Abstract

OBJECTIVES

To evaluate the effect of procalcitonin-guided management on the duration of antibiotic therapy in critically ill cancer patients with sepsis.

DESIGN

Randomized, controlled, single-blinded trial.

SETTING

A comprehensive multidisciplinary cancer hospital in Jordan.

PATIENTS

Adults with cancer treated in the ICU who were started on antibiotics for suspected infection, met the SEPSIS-3 criteria, and were expected to stay in the ICU greater than or equal to 48 hours.

INTERVENTIONS

Patients were randomized to the procalcitonin-guided or standard care (SC) arms. All patients had procalcitonin measured daily, up to 5 days or until ICU discharge or death. For the procalcitonin arm, a procalcitonin-guided algorithm was provided to guide antibiotic management, but clinicians were allowed to override the algorithm, if clinically indicated. In the SC arm, ICU clinicians were blinded to the procalcitonin levels.

MEASUREMENTS AND MAIN RESULTS

Primary outcome was time to antibiotic cessation. We also evaluated the number of antibiotic-free days at 28 days, hospital discharge, or death, whichever came first, and antibiotic defined daily doses (DDDs). We enrolled 77 patients in the procalcitonin arm and 76 in the SC arm. Mean age was 58 ± 14 (sd) years, 67% were males, 74% had solid tumors, and 13% were neutropenic. Median (interquartile range [IQR]) Sequential Organ Failure Assessment scores were 7 (6-10) and 7 (5-9) and procalcitonin concentrations (ng/mL) at baseline were 3.4 (0.8-16) and 3.4 (0.5-26), in the procalcitonin and SC arms, respectively. There was no difference in the median (IQR) time to antibiotic cessation in the procalcitonin and SC arms, 8 (4-11) and 8 (5-13), respectively (p = 0.463). Median (IQR) number of antibiotic-free days were 20 (17-24) and 20 (16-23), (p = 0.484) and total DDDs were 1541.4 and 2050.4 in the procalcitonin and SC arms, respectively.

CONCLUSIONS

In critically ill cancer patients with sepsis, procalcitonin-guided management did not reduce the duration of antibiotic treatment.

摘要

目的

评估降钙素原指导管理对脓毒症危重症癌症患者抗生素治疗时间的影响。

设计

随机、对照、单盲试验。

地点

约旦一家综合性多学科癌症医院。

患者

入住 ICU 接受抗生素治疗的成年癌症患者，疑似感染，符合 SEPSIS-3 标准，预计 ICU 入住时间大于等于 48 小时。

干预

患者随机分配至降钙素原指导组或标准治疗（SC）组。所有患者均每日检测降钙素原，最多 5 天或直至 ICU 出院或死亡。降钙素原组提供降钙素原指导算法以指导抗生素管理，但如果临床需要，临床医生可以Override 算法。在 SC 组中，ICU 临床医生对降钙素原水平进行盲法处理。

测量和主要结果

主要结局为抗生素停药时间。我们还评估了 28 天、出院或死亡时（以先发生者为准）的无抗生素天数，以及抗生素定义日剂量（DDD）。降钙素原组纳入 77 例患者，SC 组纳入 76 例患者。平均年龄为 58±14（标准差）岁，67%为男性，74%为实体瘤，13%为中性粒细胞减少症。降钙素原组和 SC 组的中位（四分位距[IQR]）序贯器官衰竭评估评分分别为 7（6-10）和 7（5-9），基线时降钙素原浓度（ng/mL）分别为 3.4（0.8-16）和 3.4（0.5-26）。降钙素原组和 SC 组的抗生素停药时间中位数（IQR）分别为 8（4-11）和 8（5-13），无统计学差异（p=0.463）。降钙素原组和 SC 组无抗生素天数的中位数（IQR）分别为 20（17-24）和 20（16-23），无统计学差异（p=0.484），降钙素原组和 SC 组的总 DDD 分别为 1541.4 和 2050.4。