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临床试验/NCT02037815
NCT02037815已完成4 期

Correlation of Measured and Calculated Serum Osmolality During Mannitol or Hypertonic Saline Infusion in Patients After Craniotomy

Capital Medical University1 个研究点 分布在 1 个国家目标入组 35 人开始时间: 2014年1月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
发起方
入组人数
35
试验地点
1
主要终点
Difference between the measured and calculated serum osmolality.

研究概览

简要总结

Osmotherapy has been used as the medical treatment for brain edema and intracranial hypertension in critically brain injured patients. Measurement of serum osmolality during osmotherapy is of clinical importance to determine clinical efficacy, adjust dosage and avoid side effect. Serum osmolality is often measured in laboratory by cryoscopic technique as the reference method. However, in clinical setting, routine measurement of serum osmolality is not feasible at bedside, either in intensive care unit (ICU) or neurosurgical ward. Therefore, clinicians usually estimate serum osmolality by using equations derived from serum osmoles that can be measured by bedside blood gas analysis or routine laboratory chemical analysis, such as sodium, potassium, urea, and glucose. In present study, mannitol or hypertonic saline will be used in patients after craniotomy, and serum osmolality will be measured before and during drug infusion. Investigators hypothesize that the correlation of measured and calculated serum osmolality is better during infusion of hypertonic saline than mannitol.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • adult patients after elective craniotomy, requiring hyperosmolar agents for prevention or treatment of brain edema

排除标准

  • age younger than 18 yr or older than 65 yr
  • history of diabetes
  • unstable hemodynamic condition
  • presence of renal failure

研究组 & 干预措施

Mannitol

Experimental

20% mannitol solution, 125 ml, IV infusion in 15 min

干预措施: 20% mannitol solution, 125 ml, IV infusion in 15 min (Drug)

Hypertonic saline

Experimental

3.1% sodium chloride solution, 125 ml, IV infusion in 15 min

干预措施: 3.1% sodium chloride solution, 125 ml, IV infusion in 15 min (Drug)

结局指标

主要结局

Difference between the measured and calculated serum osmolality.

时间窗: Immediately before the infusion of mannitol and hypertonic saline, and 15, 30, 60, 120, 240, and 360 minutes after the administration of the study drugs

次要结局

  • Concentration of serum sodium(Immediately before the infusion of mannitol and hypertonic saline, and 15, 30, 60, 120, 240, and 360 minutes after the administration of the study drugs)
  • Serum osmolality(Immediately before the infusion of mannitol and hypertonic saline, and 15, 30, 60, 120, 240, and 360 minutes after the administration of the study drugs)

研究者

发起方
Capital Medical University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Jian-Xin Zhou

Professor

Capital Medical University

研究点 (1)

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