PRagMatic Pediatric Trial of Balanced vs nOrmaL Saline FlUid in Sepsis: study protocol for the PRoMPT BOLUS randomized interventional trial.
PRagMatic Pediatric Trial of Balanced vs nOrmaL Saline FlUid in Sepsis: study protocol for the PRoMPT BOLUS randomized interventional trial.
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DOI：
10.1186/s13063-021-05717-4
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发表时间：
2021-11-06
期刊：
影响因子：
2.5
通讯作者：
Pragmatic Pediatric Trial of Balanced Versus Normal Saline Fluid in Sepsis (PRoMPT BOLUS) Investigators of the PECARN, PERC, and PREDICT Networks
中科院分区：
文献类型：
--
作者：
Weiss SL;Balamuth F;Long E;Thompson GC;Hayes KL;Katcoff H;Cook M;Tsemberis E;Hickey CP;Williams A;Williamson-Urquhart S;Borland ML;Dalziel SR;Gelbart B;Freedman SB;Babl FE;Huang J;Kuppermann N;Pragmatic Pediatric Trial of Balanced Versus Normal Saline Fluid in Sepsis (PRoMPT BOLUS) Investigators of the PECARN, PERC, and PREDICT Networks
尽管有证据表明，与富含氯化物的0.9%生理盐水相比，优先使用平衡/缓冲液可能会改善结局，但生理盐水仍然是感染性休克儿童最常用的液体。我们的目的是确定作为常规护理的一部分，使用平衡/缓冲液进行复苏是否会改善结局，部分原因是与0.9%生理盐水相比，减少了肾损伤，并且不会增加不良反应。脓毒症中平衡与正常生理盐水的实用儿科试验（PRoMPT BOLUS）研究是一项国际性、开放标签的实用干预性试验，从2020年8月25日开始在美国、加拿大和澳大利亚/新西兰的40多个研究中心进行，持续5年。在急诊科接受疑似感染性休克伴灌注异常治疗的> 6个月至< 18岁儿童将随机接受平衡/缓冲晶体（干预）或0.9%生理盐水（对照）进行初始复苏和维持液体，持续48小时。合格患者入组并使用连续编号的不透明信封随机分配，同时进行临床护理。鉴于感染性休克的生命威胁性质和开始液体复苏的治疗窗较窄，在美国，患者可根据“知情同意例外”或在加拿大和澳大利亚/新西兰“延迟同意”入组。除液体类型外，所有关于液体给药时间、体积和速率的决定仍由治疗临床医生自行决定。出于实用原因，临床医生不会对研究液体类型设盲。预计入组8800例患者。主要结局为30天内的主要肾脏不良事件（MAKE 30），包括死亡、肾脏替代治疗和持续性肾功能不全。还将分析其他有效性、安全性和生物学结局。PRoMPT BOLUS将提供高质量的证据，证明缓冲/平衡晶体液与0.9%生理盐水在紧急情况下疑似感染性休克儿童的初始液体管理中的比较有效性。PRoMPT推注于2019年9月25日首次在ClinicalTrials.gov（NCT 04102371）注册。入组于2020年8月25日开始。在线版本包含补充材料，可通过10.1186/s13063-021-05717-4获得。
Despite evidence that preferential use of balanced/buffered fluids may improve outcomes compared with chloride-rich 0.9% saline, saline remains the most commonly used fluid for children with septic shock. We aim to determine if resuscitation with balanced/buffered fluids as part of usual care will improve outcomes, in part through reduced kidney injury and without an increase in adverse effects, compared to 0.9% saline for children with septic shock. The Pragmatic Pediatric Trial of Balanced versus Normal Saline Fluid in Sepsis (PRoMPT BOLUS) study is an international, open-label pragmatic interventional trial being conducted at > 40 sites in the USA, Canada, and Australia/New Zealand starting on August 25, 2020, and continuing for 5 years. Children > 6 months to < 18 years treated for suspected septic shock with abnormal perfusion in an emergency department will be randomized to receive either balanced/buffered crystalloids (intervention) or 0.9% saline (control) for initial resuscitation and maintenance fluids for up to 48 h. Eligible patients are enrolled and randomized using serially numbered, opaque envelopes concurrent with clinical care. Given the life-threatening nature of septic shock and narrow therapeutic window to start fluid resuscitation, patients may be enrolled under “exception from informed consent” in the USA or “deferred consent” in Canada and Australia/New Zealand. Other than fluid type, all decisions about timing, volume, and rate of fluid administration remain at the discretion of the treating clinicians. For pragmatic reasons, clinicians will not be blinded to study fluid type. Anticipated enrollment is 8800 patients. The primary outcome will be major adverse kidney events within 30 days (MAKE30), a composite of death, renal replacement therapy, and persistent kidney dysfunction. Additional effectiveness, safety, and biologic outcomes will also be analyzed. PRoMPT BOLUS will provide high-quality evidence for the comparative effectiveness of buffered/balanced crystalloids versus 0.9% saline for the initial fluid management of children with suspected septic shock in emergency settings. PRoMPT BOLUS was first registered at ClinicalTrials.gov (NCT04102371) on September 25, 2019. Enrollment started on August 25, 2020. The online version contains supplementary material available at 10.1186/s13063-021-05717-4.
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DOI：
10.1159/000363725
发表时间：
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期刊：
Nephron. Clinical practice
影响因子：
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