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一项比较去甲肾上腺素和肾上腺素作为新生儿液体难治性感染性休克一线血管升压药的前瞻性随机对照试验。

A pilot randomized controlled trial comparing noradrenaline and adrenaline as a first-line vasopressor for fluid-refractory septic shock in neonates.

作者信息

Garegrat Reema, Patnaik Suprabha, Suryawanshi Sonali, Chetan Chinmay, Banait Nishant, Singh Pari, Kallimath Aditya, Soni Naharmal B, Singh Yogen, Suryawanshi Pradeep

机构信息

Department of Neonatology, Bharati Vidyapeeth Hospital and Research Institute, Pune, India.

Department of Pharmacology, Bharati Vidyapeeth Hospital and Research Institute, Pune, India.

出版信息

Front Pediatr. 2024 Oct 3;12:1443990. doi: 10.3389/fped.2024.1443990. eCollection 2024.

DOI:10.3389/fped.2024.1443990
PMID:39421034
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC11484266/
Abstract

BACKGROUND AND STUDY DESIGN

Limited data exists on noradrenaline therapy in neonatal septic shock. We compared the efficacy of noradrenaline with adrenaline in neonatal septic shock. This single center, open label, pilot randomized controlled trial included neonates with clinical evidence of sepsis and shock.

STUDY OUTCOMES

Primary outcomes were: 1) resolution of shock one hour after treatment, and 2) mortality during hospital stay. Secondary outcomes included: need for additional vasopressors; hemodynamic stability without further administration of vasopressors for ≥2 h; changes in blood pressure and heart rate after 1 h of vasopressor treatment; and morbidities during the hospital stay.

RESULTS

Of 65 eligible neonates, 42 were randomized (21 each in adrenaline and noradrenaline treatment arms) between August 2020 and January 2022, at level III neonatal intensive care unit (NICU) of Bharati Vidyapeeth Deemed University Medical College and Hospital (BVDUMCH). The mean (SD) gestational age and mean (SD) birth weight were 36.1(4.2) weeks and 1.8 (0.2) kilograms birth weight for noradrenaline and 36.9 (4.1) weeks and 1.7 (0.7) kilograms for adrenaline. Shock resolved within 1 h of vasopressor therapy in 76.2% neonates in the noradrenaline arm and 61.9% in adrenaline arm ( value-0.53). Mortality during hospital stay was 28.6% (6/21) in noradrenaline group and 33.3% (7/21) in adrenaline group ( value- 0.58). Additional vasopressors were required in 23.8% neonates of the noradrenaline group compared to 38.1% neonates in adrenaline arm ( value-0.53). Median (SD) duration of intensive care stay was 6 (SD) days in the noradrenaline group and 10 (SD) days in the adrenaline group ( value-0.045).

CONCLUSION

Among neonates with septic shock, the efficacy of noradrenaline was comparable to adrenaline in resolving septic shock after one hour of infusion and on the mortality during hospital stay.

CLINICAL TRIAL REGISTRATION

https://ctri.nic.in/Clinicaltrials/pmaindet2.php?EncHid=NDI2NTc=&Enc=&userName=noradrenaline, Clinical Trials Registry - India with identifier CTRI/2020/08/027185 (17/08/2020).

摘要

背景与研究设计

关于去甲肾上腺素治疗新生儿感染性休克的数据有限。我们比较了去甲肾上腺素与肾上腺素治疗新生儿感染性休克的疗效。这项单中心、开放标签、试点随机对照试验纳入了有败血症和休克临床证据的新生儿。

研究结果

主要结果为:1)治疗1小时后休克缓解,以及2)住院期间的死亡率。次要结果包括:是否需要额外的血管升压药;无需进一步使用血管升压药≥2小时的血流动力学稳定性;血管升压药治疗1小时后血压和心率的变化;以及住院期间的发病率。

结果

在巴拉蒂维迪佩特被视为大学医学院和医院(BVDUMCH)的三级新生儿重症监护病房(NICU),于2020年8月至2022年1月期间,65名符合条件的新生儿中,42名被随机分组(去甲肾上腺素治疗组和肾上腺素治疗组各21名)。去甲肾上腺素组的平均(标准差)胎龄和平均(标准差)出生体重分别为36.1(4.2)周和1.8(0.2)千克,肾上腺素组为36.9(4.1)周和1.7(0.7)千克。去甲肾上腺素组76.2%的新生儿在血管升压药治疗1小时内休克缓解,肾上腺素组为61.9%( 值 -0.53)。去甲肾上腺素组住院期间死亡率为28.6%(6/21),肾上腺素组为33.3%(7/21)( 值 -0.58)。去甲肾上腺素组23.8%的新生儿需要额外的血管升压药,而肾上腺素组为38.1%( 值 -0.53)。去甲肾上腺素组重症监护住院时间的中位数(标准差)为6(标准差)天,肾上腺素组为10(标准差)天( 值 -0.045)。

结论

在感染性休克新生儿中,去甲肾上腺素在输注1小时后缓解感染性休克及住院期间死亡率方面的疗效与肾上腺素相当。

临床试验注册

https://ctri.nic.in/Clinicaltrials/pmaindet2.php?EncHid=NDI2NTc=&Enc=&userName=noradrenaline,印度临床试验注册中心,标识符CTRI/2020/08/027185(2020年8月17日)。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/8cc5/11484266/99b8e21ca1e3/fped-12-1443990-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/8cc5/11484266/99b8e21ca1e3/fped-12-1443990-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/8cc5/11484266/99b8e21ca1e3/fped-12-1443990-g001.jpg

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