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一项针对住院儿童等张与低张维持静脉输液的随机对照试验。

A randomized controlled trial of isotonic versus hypotonic maintenance intravenous fluids in hospitalized children.

机构信息

Dept, of Pediatrics, Montreal Children's Hospital, McGill University, Montreal, QC, Canada.

出版信息

BMC Pediatr. 2011 Sep 23;11:82. doi: 10.1186/1471-2431-11-82.

DOI:10.1186/1471-2431-11-82
PMID:21943218
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC3187723/
Abstract

BACKGROUND

Isotonic saline has been proposed as a safer alternative to traditional hypotonic solutions for intravenous (IV) maintenance fluids to prevent hyponatremia. However, the optimal tonicity of maintenance intravenous fluids in hospitalized children has not been determined. The objective of this study was to estimate and compare the rates of change in serum sodium ([Na]) for patients administered either hypotonic or isotonic IV fluids for maintenance needs.

METHODS

This was a masked controlled trial. Randomization was stratified by admission type: medical patients and post-operative surgical patients, aged 3 months to 18 years, who required IV fluids for at least 8 hours. Patients were randomized to receive either 0.45% or 0.9% saline in 5.0% dextrose. Treating physicians used the study fluid for maintenance; infusion rate and the use of additional fluids were left to their discretion.

RESULTS

Sixteen children were randomized to 0.9% saline and 21 to 0.45% saline. Baseline characteristics, duration (average of 12 hours) and rate of study fluid infusion, and the volume of additional isotonic fluids given were similar for the two groups. [Na] increased significantly in the 0.9% group (+0.20 mmol/L/h [IQR +0.03, +0.4]; P = 0.02) and increased, but not significantly, in the 0.45% group (+0.08 mmol/L/h [IQR -0.15, +0.16]; P = 0.07). The rate of change and absolute change in serum [Na] did not differ significantly between groups.

CONCLUSIONS

When administered at the appropriate maintenance rate and accompanied by adequate volume expansion with isotonic fluids, 0.45% saline did not result in a drop in serum sodium during the first 12 hours of fluid therapy in children without severe baseline hyponatremia. Confirmation in a larger study is strongly recommended.

CLINICAL TRIAL REGISTRATION NUMBER

NCT00457873 (http://www.clinicaltrials.gov/).

摘要

背景

人们提出,与传统的低渗溶液相比,等渗生理盐水作为静脉(IV)维持液更为安全,可以预防低钠血症。然而,住院儿童维持静脉输液的最佳渗透压尚未确定。本研究的目的是评估和比较接受低渗或等渗 IV 液维持治疗的患者血清钠([Na])变化率。

方法

这是一项设盲对照试验。根据入院类型(内科患者和术后外科患者)进行分层随机分组,年龄 3 个月至 18 岁,需要至少 8 小时 IV 补液。患者被随机分配接受 0.45%或 0.9%生理盐水加 5.0%葡萄糖。治疗医生使用研究液体进行维持治疗;输液速度和额外液体的使用由他们自行决定。

结果

16 名儿童被随机分配至 0.9%生理盐水组,21 名儿童被随机分配至 0.45%生理盐水组。两组患者的基线特征、研究液体的输注时间(平均 12 小时)和输注速度、以及给予的额外等渗液体量相似。0.9%组的[Na]显著升高(+0.20mmol/L/h [IQR +0.03,+0.4];P=0.02),0.45%组也有所升高,但无统计学意义(+0.08mmol/L/h [IQR -0.15,+0.16];P=0.07)。两组之间[Na]的变化率和绝对变化无显著差异。

结论

在适当的维持速度下,并用等渗液体进行充分的容量扩张,对于没有严重基线低钠血症的儿童,在开始接受液体治疗的最初 12 小时内,0.45%生理盐水不会导致血清钠下降。强烈建议在更大的研究中进一步证实。

临床试验注册

NCT00457873(http://www.clinicaltrials.gov/)。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/c950/3187723/dfd6e91bb5be/1471-2431-11-82-2.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/c950/3187723/b9e1319fa7e8/1471-2431-11-82-1.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/c950/3187723/dfd6e91bb5be/1471-2431-11-82-2.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/c950/3187723/b9e1319fa7e8/1471-2431-11-82-1.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/c950/3187723/dfd6e91bb5be/1471-2431-11-82-2.jpg

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