低维持速率给予低张及等张生理盐水用于预防术后儿科患者血浆钠离子显著变化的疗效：一项前瞻性随机非盲研究方案。
The efficacy of hypotonic and near-isotonic saline for parenteral fluid therapy given at low maintenance rate in preventing significant change in plasma sodium in post-operative pediatric patients: protocol for a prospective randomized non-blinded study.
机构信息
Karolinska Institutet, Department for Clinical Science, Intervention and Technology, Division of Pediatrics, Karolinska University Hospital, Huddinge, Stockholm, Sweden.
出版信息
BMC Pediatr. 2011 Jul 5;11:61. doi: 10.1186/1471-2431-11-61.
BACKGROUND
Hyponatremia is the most frequent electrolyte abnormality observed in post-operative pediatric patients receiving intravenous maintenance fluid therapy. If plasma sodium concentration (p-Na+) declines to levels below 125 mmol/L in < 48 h, transient or permanent brain damage may occur. There is an intense debate as to whether the administered volume (full rate vs. restricted rate of infusion) and the composition of solutions used for parenteral maintenance fluid therapy (hypotonic vs. isotonic solutions) contribute to the development of hyponatremia. So far, there is no definitive pediatric data to support a particular choice of parenteral fluid for maintenance therapy in post-surgical patients.
METHODS/DESIGN: Our prospective randomized non-blinded study will be conducted in healthy children and adolescents aged 1 to 14 years who have been operated for acute appendicitis. Patients will be randomized either to intravenous hypotonic (0.23% or 0.40% sodium chloride in glucose, respectively) or near-isotonic (0.81% sodium chloride in glucose) solution given at approximately three-fourths of the average maintenance rate. The main outcome of interest from this study is to evaluate 24 h post-operatively whether differences in p-Na+ between treatment groups are large enough to be of clinical relevance. In addition, water and electrolyte balance as well as regulatory hormones will be measured.
DISCUSSION
This study will provide valuable information on the efficacy of hypotonic and near-isotonic fluid therapy in preventing a significant decrease in p-Na+. Finally, by means of careful electrolyte and water balance and by measuring regulatory hormones our results will also contribute to a better understanding of the physiopathology of post-operative changes in p-Na+ in a population at risk for hyponatremia.
TRIAL REGISTRATION
The protocol for this study is registered with the current controlled trials registry; registry number: ISRCTN43896775.
背景
低钠血症是术后接受静脉维持液治疗的儿科患者最常见的电解质异常。如果在 48 小时内血浆钠浓度（p-Na+）降至 125mmol/L 以下，可能会发生短暂或永久性脑损伤。对于静脉维持液治疗中给予的液体量（全速输注与限制输注）和用于静脉维持液治疗的溶液的组成（低渗溶液与等渗溶液）是否会导致低钠血症的发生，存在激烈的争论。到目前为止，尚无明确的儿科数据支持手术患儿术后维持治疗中选择特定的静脉输液。
方法/设计：我们将进行一项前瞻性随机非盲研究，纳入年龄在 1 至 14 岁、因急性阑尾炎接受手术的健康儿童和青少年。患者将随机分为静脉输注低渗液（分别为 0.23%或 0.40%氯化钠葡萄糖溶液）或接近等渗液（0.81%氯化钠葡萄糖溶液），速度约为平均维持速度的四分之三。本研究的主要观察终点是评估术后 24 小时两组间 p-Na+的差异是否大到具有临床意义。此外，还将测量水和电解质平衡以及调节激素。
讨论
本研究将提供有关低渗和接近等渗液治疗在预防 p-Na+显著下降方面的疗效的有价值的信息。最后，通过仔细的电解质和水平衡以及测量调节激素，我们的结果也将有助于更好地理解术后 p-Na+变化的病理生理学，特别是在易发生低钠血症的人群中。
试验注册
本研究方案在当前对照试验注册库中注册；注册号：ISRCTN43896775。
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