肾移植后,许多儿童经历了急性电解质和酸碱失衡。严重时,这可能会导致并发症,包括癫痫发作,脑水肿和死亡。围手术期给予儿童相对大量的静脉输液,以建立供体肾脏的灌注,其中大部分来自在世和已故的成人捐赠者。由于临床医生对钠的担忧,低渗静脉输液通常在移植后使用,大剂量给药时等渗替代品的氯化物和钾含量。血浆-Lyte148是等渗的,含钠的平衡静脉输液,氯化物,钾和镁的浓度相当于血浆的浓度。与目前的实践相比,有一个生理基础可以预期,血浆-Lyte148将减少肾移植后儿童临床上显着的电解质和酸碱异常的发生率。血浆-Lyte的使用和儿童肾移植结果的评估(PLUTO)试验的目的是确定使用血浆-Lyte148与目前使用的静脉输液相比,儿科肾移植受者临床上明显异常的血浆电解质水平的发生率是否会有所不同。
PLUTO是一个务实的,开放标签,在小儿肾移植受者中比较血浆-Lyte148与当前护理的随机对照试验,在9个英国儿科肾脏移植中心进行。总共144名接受肾脏移植的儿童将被随机分配到术中和术后接受血浆-Lyte148(干预),或当前流体。除了静脉输液成分,所有参与者将接受标准的临床移植治疗.主要结果指标是移植后最初72小时的急性低钠血症,定义为实验室血浆钠浓度<135mmol/L次要结果包括急性低钠血症的症状,其他电解质和酸碱失衡和移植肾功能。将使用逻辑回归模型对主要结果进行分析,以调整供体类型(活体与已故供体),患者体重(<20kgvs移植前≥20kg)和移植中心作为随机效应。
该试验于2020年1月20日获得卫生研究机构的批准。研究结果将通过国家和国际会议和同行评审期刊提交给学术团体。患者和公众参与小组将在向公共领域传播研究结果方面发挥重要作用。
2019-003025-22和16586164。
Acute electrolyte and acid-base imbalance is experienced by many children following kidney transplantation. When severe, this can lead to complications including seizures, cerebral oedema and death. Relatively large volumes of intravenous fluid are administered to children perioperatively in order to establish perfusion to the donor kidney, the majority of which are from living and deceased adult donors. Hypotonic intravenous fluid is commonly used in the post-transplant period due to clinicians\' concerns about the sodium, chloride and potassium content of isotonic alternatives when administered in large volumes.Plasma-Lyte 148 is an isotonic, balanced intravenous fluid that contains sodium, chloride, potassium and magnesium with concentrations equivalent to those of plasma. There is a physiological basis to expect that Plasma-Lyte 148 will reduce the incidence of clinically significant electrolyte and acid-base abnormalities in children following kidney transplantation compared with current practice.The aim of the Plasma-Lyte Usage and Assessment of Kidney Transplant Outcomes in Children (PLUTO)
trial was to determine whether the incidence of clinically significantly abnormal plasma electrolyte levels in paediatric kidney transplant recipients will be different with the use of Plasma-Lyte 148 compared with intravenous fluid currently administered.
PLUTO is a pragmatic, open-label, randomised controlled
trial comparing Plasma-Lyte 148 to current care in paediatric kidney transplant recipients, conducted in nine UK paediatric kidney transplant centres.A total of 144 children receiving kidney transplants will be randomised to receive either Plasma-Lyte 148 (the intervention) intraoperatively and postoperatively, or current fluid. Apart from intravenous fluid composition, all participants will receive standard clinical transplant care.The primary outcome measure is acute hyponatraemia in the first 72 hours post-transplant, defined as laboratory plasma sodium concentration of <135 mmol/L. Secondary outcomes include symptoms of acute hyponatraemia, other electrolyte and acid-base imbalances and transplant kidney function.The primary outcome will be analysed using a logistic regression model adjusting for donor type (living vs deceased donor), patient weight (<20 kg vs ≥20 kg pretransplant) and transplant centre as a random effect.
The
trial received Health Research Authority approval on 20 January 2020. Findings will be presented to academic groups via national and international conferences and peer-reviewed journals. The patient and public involvement group will play an important part in disseminating the
study findings to the public domain.
2019-003025-22 and 16586164.