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小儿感染性休克中第五百分位数与第50百分位数平均血压目标:一项随机对照试验

Fifth Centile Versus 50th Centile Mean Blood Pressure Targets in Pediatric Septic Shock: A Randomized Controlled Trial.

作者信息

Shah Sachin, Kaul Amita, Shiwarkar Ganesh, Nare Rajesh, Khandare Jayant

机构信息

All authors: Neonatal and Pediatric Intensive Care Services, Surya Mother and Child Superspecialty Hospital, Pune, Maharashtra, India.

出版信息

Crit Care Med. 2025 Aug 1;53(8):e1581-e1589. doi: 10.1097/CCM.0000000000006718. Epub 2025 Aug 5.

DOI:10.1097/CCM.0000000000006718
PMID:40511998
Abstract

OBJECTIVES

Hypotension is common in septic children, mean blood pressure (MBP) guides vasoactive agent titration. However, the Surviving Sepsis Guidelines for children were unable to recommend whether to target the 5th or 50th MBP percentile for septic shock. We aim to compare two MBP targets (5th vs. 50th percentile) for titrating vasoactive agents in septic shock patients.

DESIGN

Single-center, open-label, randomized noninferiority trial.

SETTING

It was conducted in a tertiary care PICU in India from April 2021 to March 2024.

PATIENTS

Patients 1 month to 16 years old with septic shock unresponsive to fluids and requiring vasopressors.

INTERVENTIONS

Children with septic shock were randomly assigned to either the 5th or 50th percentile MBP group, with vasopressor treatment adjusted to maintain the target blood pressure (BP) for each group.

MEASUREMENTS AND MAIN RESULTS

The primary outcome was 28-day all-cause mortality. Secondary outcomes included PICU/hospital stay, duration of vasoactive use, vasopressor-related adverse events, need for continuous renal replacement therapy (CRRT), invasive ventilation, and prevalence of acute respiratory distress syndrome (ARDS). A total of 144 children were enrolled. At 28 days, mortality did not differ significantly between groups: 16.9% (12/71) in the 5th centile group vs. 23.2% (17/73) in the 50th centile group ( p = 0.41; risk difference, 6.3; 95% CI, -6.9 to 19.2). Norepinephrine use was higher in the 50th centile group (85% vs. 67%; p = 0.04). Vasoactive duration was longer in the 50th centile group (30.4 ± 13.3 vs. 18.8 ± 10.8; p = 0.001). The Vasoactive-Inotropic Score was also higher (64.0 ± 35.7 vs. 45.2 ± 29.6; p = 0.001). ARDS prevalence was significantly higher in the 50th centile group (32.8% vs. 16.9%; p = 0.02). No significant differences were found in other secondary outcomes like length of stay, ventilation duration, need for CRRT, or adverse events.

CONCLUSIONS

Targeting a lower MBP (5th vs. 50th centile) in septic shock showed no significant difference in 28-day mortality. This suggests a lower BP target may be safe, reducing vasoactive drug use and related side effects.

摘要

目的

低血压在脓毒症患儿中很常见,平均血压(MBP)指导血管活性药物的滴定。然而,儿童脓毒症存活指南无法推荐针对脓毒症休克的MBP百分位数是第5还是第50来作为目标。我们旨在比较两个MBP目标(第5百分位数与第50百分位数)用于滴定脓毒症休克患者的血管活性药物。

设计

单中心、开放标签、随机非劣效性试验。

地点

于2021年4月至2024年3月在印度一家三级护理儿科重症监护病房(PICU)进行。

患者

年龄在1个月至16岁之间,对液体无反应且需要血管加压药的脓毒症休克患者。

干预措施

脓毒症休克患儿被随机分配到MBP第5百分位数组或第50百分位数组,调整血管加压药治疗以维持每组的目标血压(BP)。

测量指标和主要结果

主要结局是28天全因死亡率。次要结局包括PICU/住院时间、血管活性药物使用持续时间、血管加压药相关不良事件、持续肾脏替代治疗(CRRT)需求、有创通气以及急性呼吸窘迫综合征(ARDS)的患病率。共纳入144名儿童。在28天时,两组死亡率无显著差异:第5百分位数组为16.9%(12/71),第50百分位数组为23.2%(17/73)(p = 0.41;风险差异为6.3;95%CI为-6.9至19.2)。第50百分位数组去甲肾上腺素使用率更高(85%对67%;p = 0.04)。第50百分位数组血管活性药物使用持续时间更长(30.4±13.3对18.8±10.8;p = 0.001)。血管活性-正性肌力评分也更高(64.0±35.7对45.2±29.6;p = 0.001)。第50百分位数组ARDS患病率显著更高(32.8%对16.9%;p = 0.02)。在其他次要结局如住院时间、通气持续时间、CRRT需求或不良事件方面未发现显著差异。

结论

在脓毒症休克中,将较低的MBP(第5百分位数与第50百分位数相比)作为目标在28天死亡率方面无显著差异。这表明较低的血压目标可能是安全的,可减少血管活性药物的使用及相关副作用。

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