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

Q4 Medicine Critical care explorations Pub Date : 2024-10-21 eCollection Date: 2024-10-01 DOI:10.1097/CCE.0000000000001173

Lama H Nazer, Wedad Awad, Hadeel Thawabieh, Aseel Abusara, Deema Abdelrahman, Awad Addassi, Osama Abuatta, Maher Sughayer, Yahya Shehabi

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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.

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Procalcitonin-Guided Management and Duration of Antibiotic Therapy in Critically Illous Cancer Patients with Sepsis (Pro-Can Study)：随机对照试验

目的评估降钙素原指导疗法对脓毒症重症癌症患者抗生素治疗时间的影响：随机对照单盲试验：约旦一家综合性多学科癌症医院：患者：在重症监护室接受治疗的成人癌症患者，因疑似感染而开始使用抗生素，符合 SEPSIS-3 标准，预计在重症监护室的住院时间超过或等于 48 小时：患者被随机分配到降钙素原指导组或标准护理组（SC）。所有患者每天都要测量降钙素原，最长测量时间为 5 天或直到 ICU 出院或死亡。在丙种球蛋白治疗组中，提供了一种丙种球蛋白指导算法来指导抗生素治疗，但临床医生可根据临床需要更改算法。在SC组中，ICU临床医生对降钙素原水平保持盲法：主要结果是停止使用抗生素的时间。我们还评估了28天、出院或死亡（以先到者为准）时的无抗生素天数以及抗生素定义日剂量（DDDs）。我们在降钙素治疗组招募了 77 名患者，在 SC 治疗组招募了 76 名患者。平均年龄为 58 ± 14（sd）岁，67% 为男性，74% 患有实体瘤，13% 患有中性粒细胞减少症。序贯器官衰竭评估评分的中位数（四分位间距 [IQR] ）分别为 7（6-10）和 7（5-9），基线时的降钙素原浓度（纳克/毫升）分别为 3.4（0.8-16）和 3.4（0.5-26）。在停用抗生素的中位（IQR）时间上，丙种球蛋白组和SC组没有差异，分别为8（4-11）和8（5-13）（p = 0.463）。无抗生素治疗天数的中位数（IQR）分别为20（17-24）天和20（16-23）天（p = 0.484），而降钙素治疗组和SC治疗组的总DDD分别为1541.4和2050.4：对于患有败血症的重症癌症患者，降钙素原指导下的治疗并不会缩短抗生素治疗时间。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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