开颅术后患者输注甘露醇或高渗盐水期间实测与计算血清渗透压的相关性：一项随机对照试验的研究方案和统计分析计划
Correlation of measured and calculated serum osmolality during mannitol or hypertonic saline infusion in patients after craniotomy: a study protocol and statistical analysis plan for a randomised controlled trial.
作者信息
Li Qian, Xu Ming, Zhou Jian-Xin
机构信息
Department of Critical Care Medicine, Beijing Tiantan Hospital, Capital Medical University, Beijing, China.
出版信息
BMJ Open. 2014 Apr 23;4(4):e004921. doi: 10.1136/bmjopen-2014-004921.
INTRODUCTION
Brain oedema is a major complication after craniotomy. Hyperosmolar agents have been used as the medical treatment for this condition. Measurement and estimation of serum osmolality during hyperosmolar agent infusion is of clinical importance to evaluate clinical efficacy, adjust dosage and avoid side effects. However, several studies have shown that calculated serum osmolality may lead to a systematic bias compared with direct measurement. In the present study, mannitol or hypertonic saline (HS) will be used in patients after elective craniotomy. We aim to determine the accuracy of serum osmolality estimation during the application of hyperosmolar agent.
METHODS AND ANALYSIS
The study is a prospective, randomised, double-blinded, controlled, parallel-group design. Adult patients requiring the use of hyperosmolar agents for the prevention or treatment of postoperative brain oedema are enrolled and assigned randomly to one of the two treatment study groups, labelled as 'M group' and 'HS group'. Patients in the M and HS groups receive intravenous infusion of 125 mL of either 20% mannitol or 3.1% sodium chloride solution, respectively. Data will be collected immediately before the infusion of study agents, 15, 30, 60, 120, 240 and 360 min after the start of infusion of experimental agents, which includes serum osmolality, concentration of serum sodium, potassium, urea and glucose. Serum osmolality will be measured by means of freezing point depression. Estimated serum osmolality will also be calculated by using four formulas published previously. Osmole gap is calculated as the difference between the measured and the estimated values. The primary endpoint is the correlation of measured and estimated serum osmolality during hyperosmolar agent infusion.
ETHICS AND DISSEMINATION
The study was approved by the International Review Board (IRB) of Beijing Tiantan Hospital, Capital Medical University. Study findings will be disseminated through peer-reviewed publications and conference presentations.
TRIAL REGISTRATION NUMBER
ClinicalTrials.gov identifier: NCT02037815.
引言
脑水肿是开颅术后的主要并发症。高渗药物已被用于治疗这种病症。在输注高渗药物期间测量和估算血清渗透压对于评估临床疗效、调整剂量以及避免副作用具有临床重要性。然而，多项研究表明，与直接测量相比，计算得出的血清渗透压可能会导致系统偏差。在本研究中，将对择期开颅术后的患者使用甘露醇或高渗盐水（HS）。我们旨在确定在应用高渗药物期间血清渗透压估算的准确性。
方法与分析
本研究采用前瞻性、随机、双盲、对照、平行组设计。纳入需要使用高渗药物预防或治疗术后脑水肿的成年患者，并将其随机分配至两个治疗研究组之一，分别标记为“M组”和“HS组”。M组和HS组的患者分别接受静脉输注125 mL的20%甘露醇或3.1%氯化钠溶液。在输注研究药物前、输注实验药物开始后15、30、60、120、240和360分钟立即收集数据，包括血清渗透压、血清钠、钾、尿素和葡萄糖浓度。血清渗透压将通过冰点降低法测量。还将使用先前发表的四个公式计算估算的血清渗透压。渗透摩尔间隙计算为测量值与估算值之间的差值。主要终点是在输注高渗药物期间测量的和估算的血清渗透压之间的相关性。
伦理与传播
本研究已获得首都医科大学附属北京天坛医院国际审查委员会（IRB）的批准。研究结果将通过同行评审出版物和会议报告进行传播。
试验注册号
ClinicalTrials.gov标识符：NCT02037815。
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