qSOFA combined with suPAR for early risk detection and guidance of antibiotic treatment in emergency department: a bit sweet and a bit sour randomized controlled trial,Critical Care

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qSOFA combined with suPAR for early risk detection and guidance of antibiotic treatment in emergency department: a bit sweet and a bit sour randomized controlled trial
Critical Care ( IF 15.1 ) Pub Date : 2024-05-13 , DOI: 10.1186/s13054-024-04944-w
Bharat Paliwal , Nikhil Kothari , Trishita Saha , Pradeep Bhatia

With great interest, we read the article by Adami et al. [1] on qSOFA (quick sepsis related organ failure assessment score) combined with suPAR (soluble urokinase plasminogen activator receptor) for early risk detection and guidance of antibiotic treatment in emergency department. Early identification and initiation of antibiotics in sepsis is crucial but at times we fail to identify it leading to poor outcome of the patients. Earlier when qSOFA was used, sepsis was identified as qSOFA greater than 2 but in the article the authors have tried to identify sepsis when qSOFA is 1 combined with suPAR values. The approach is novel and we want to congratulate the authors for the same. The results shared for the antibiotic receiving group in the study also favors the approach over placebo. With these sweet parts there are some unclear sour aspects of the study too.

First, the surviving sepsis guidelines mentions that early initiation of antibiotic is necessary and that culture need to be taken prior to initiation of antibiotic. This is because a single dose of antibiotic can lead to negative culture reports despite infection. We could not find information on time of culture and pre-emptive administration of antibiotics in the study.

Second, the focus of study was qSOFA but in first part of the study recruitment of subjects was based on two signs of SIRS (Systemic inflammatory response syndrome). The criteria of qSOFA and SIRS is not interchangeable. No two parameters overlap between SIRS criteria (temperature, heart rate, respiratory rate and white blood cell count) and qSOFA parameters (respiratory rate, altered mental status and hypotension). Thus the recruitment likely included patient with only one common factor i.e. the respiratory rate, restricting recruitment to particular subset of patient and hence must have missed suitable patients which could fulfilled inclusion criteria based on blood pressure or neurological parameters. This affects generalizability of results. Hence also, the suPAR cut off values may be reflection of patients with respiratory pathology and likely also be the reason the meropenem group in the SUPERIOR (SUPar-guided doublE-blind randomized controlled trial of Initiation Of antibiotics foR presumed infection at the emergency department) study showed significant advantage compared to placebo, since respiratory cases constituting the majority of recruited patients.

Third and most importantly, the number needed to do an adequately powered study was supposed to be 110 in each group but only 91 patients in total were enrolled due to the covid pandemic which is less than 50% of the required sample size. The sample size is calculated based on statistical significance of primary objective. Though results were in favour of the Meropenem group but the numbers enrolled in study is statistically insufficient. Hence the inference from the study may be due to chance rather than fact. As such also the p value does not carry any significance in this study.

Fourthly, there might be ethical issue with the design. The placebo group receiving saline was devoid of beneficial effect of early initiation of antibiotic as all the patients recruited were treated as per sepsis protocol. This hold more significance especially when earlier studies have shown suPAR > 12 ng/mL independent predictor of unfavorable outcome or death in the first 28 days for patients with infection [2]. Is it ethical to deprive 1st dose in view of available literature?

Despite these, however the results of current study are motivating for a prospective study in future after taking into consideration the shortcomings observed in the current study.

No datasets were generated or analysed during the current study.

Adami ME, Kotsaki A, Antonakos N, et al. qSOFA combined with suPAR for early risk detection and guidance of antibiotic treatment in the emergency department: a randomized controlled trial. Crit Care. 2024;28:42.
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Giamarellos-Bourboulis EJ, Norrby-Teglund A, Mylona V, et al. Risk assessment in sepsis: a new prognostication rule by APACHE II score and serum soluble urokinase plasminogen activator receptor. Crit Care. 2012;16(4):R149.
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Authors and Affiliations

Department of Anaesthesiology and Critical Care, All India Institute of Medical Sciences, Jodhpur, Rajasthan, India
Bharat Paliwal, Nikhil Kothari, Trishita Saha & Pradeep Bhatia

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Bharat PaliwalView author publications
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Nikhil KothariView author publications
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Trishita SahaView author publications
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Pradeep BhatiaView author publications
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BP, TS and NK prepared the manuscript and all authors reviewed it. TS is the corresponding author.

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Correspondence to Trishita Saha.

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The authors declare no competing interests.

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Paliwal, B., Kothari, N., Saha, T. et al. qSOFA combined with suPAR for early risk detection and guidance of antibiotic treatment in emergency department: a bit sweet and a bit sour randomized controlled trial. Crit Care 28, 161 (2024). https://doi.org/10.1186/s13054-024-04944-w

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Received: 28 April 2024
Accepted: 06 May 2024
Published: 13 May 2024
DOI: https://doi.org/10.1186/s13054-024-04944-w

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中文翻译：

qSOFA联合suPAR早期风险检测并指导急诊抗生素治疗：有点甜有点酸的随机对照试验

我们怀着极大的兴趣阅读了 Adami 等人的文章。 [1] qSOFA（脓毒症相关器官衰竭快速评估评分）联合suPAR（可溶性尿激酶纤溶酶原激活剂受体）用于早期风险检测并指导急诊科抗生素治疗。脓毒症的早期识别和开始使用抗生素至关重要，但有时我们无法识别它，导致患者预后不佳。早些时候，当使用 qSOFA 时，脓毒症被识别为 qSOFA 大于 2，但在本文中，作者尝试在 qSOFA 为 1 与 suPAR 值相结合时识别脓毒症。这种方法很新颖，我们要祝贺作者。研究中抗生素接受组的结果也优于安慰剂。除了这些甜蜜的部分之外，这项研究也存在一些不清楚的酸味方面。

首先，现存的败血症指南提到，早期开始使用抗生素是必要的，并且需要在开始使用抗生素之前进行培养。这是因为尽管存在感染，单剂量抗生素仍可能导致培养结果呈阴性。我们在研究中找不到有关培养时间和预先施用抗生素的信息。

其次，研究的重点是 qSOFA，但在研究的第一部分中，受试者的招募是基于 SIRS（全身炎症反应综合征）的两种体征。 qSOFA 和 SIRS 的标准不可互换。 SIRS 标准（体温、心率、呼吸频率和白细胞计数）和 qSOFA 参数（呼吸频率、精神状态改变和低血压）之间没有两个参数重叠。因此，招募可能包括仅具有一个共同因素（即呼吸频率）的患者，将招募限制于患者的特定子集，因此必定错过了能够满足基于血压或神经学参数的纳入标准的合适患者。这会影响结果的普遍性。因此，suPAR 截止值可能反映了患有呼吸道疾病的患者，也可能是美罗培南组处于 SUPERIOR 组的原因（SUPar 指导下的双盲随机对照试验，针对急诊室假定感染开始使用抗生素）与安慰剂相比，该研究显示出显着的优势，因为呼吸道病例占招募患者的大多数。

第三，也是最重要的一点，进行一项充分有力的研究所需的人数本应为每组 110 名患者，但由于新冠疫情，总共只招募了 91 名患者，不足所需样本量的 50%。样本量是根据主要目标的统计显着性计算的。尽管结果有利于美罗培南组，但参加研究的人数在统计上还不够。因此，这项研究的推论可能是出于偶然而不是事实。因此，p 值在本研究中也没有任何意义。

第四，设计可能存在伦理问题。接受盐水的安慰剂组缺乏早期开始使用抗生素的有益效果，因为所有招募的患者均按照脓毒症方案进行治疗。这具有更重要的意义，尤其是当早期研究表明 suPAR > 12 ng/mL 是感染患者前 28 天内不良结果或死亡的独立预测因子时 [2]。根据现有文献，剥夺第一剂剂量是否符合道德？

尽管如此，考虑到当前研究中观察到的缺点，当前研究的结果对未来的前瞻性研究具有启发性。

当前研究期间没有生成或分析数据集。

Adami ME、Kotsaki A、Antonakos N 等人。 qSOFA 联合 suPAR 用于早期风险检测并指导急诊科抗生素治疗：一项随机对照试验。危重护理。 2024 年；28:42。
文章 PubMed PubMed Central Google Scholar
Giamarellos-Bourboulis EJ、Norrby-Teglund A、Mylona V 等。脓毒症风险评估：APACHE II 评分和血清可溶性尿激酶纤溶酶原激活剂受体的新预测规则。危重护理。 2012；16(4)：R149。
文章 PubMed PubMed Central Google Scholar

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全印度医学科学研究所麻醉科和重症监护科，印度拉贾斯坦邦焦特布尔
巴拉特·帕利瓦尔、尼基尔·科塔里、特里希塔·萨哈和普拉迪普·巴蒂亚

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BP、TS 和 NK 准备了手稿，所有作者都进行了审阅。 TS为通讯作者。

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