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临床试验/CTRI/2018/12/016728
CTRI/2018/12/016728已完成不适用

Comparison of normal saline and balanced salt solution as maintenance fluid on acid-base and electrolyte status in traumatic brain injury patients - a prospective randomized double blind study

Institute of Medical Sciences1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2018年12月25日最近更新:

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
100
试验地点
1
主要终点
Acid base and electrolyte status

研究概览

简要总结

The study will be conducted in ICU of trauma centre, department of anaesthesiology, IMS, BHU Varanasi after written informed consent and institutional ethical approval. After CTRI registration, 100 patients of isolated nonoperative head injury, age 18 to 60 years admitted to trauma ICU within 24hr of injury will be included. Patient will be excluded from study if baseline electrolyte are outside normal range, on ionotropic support, having systemic illness like diabetes, hypertention, patient with end organ damage, polytrauma patients and patient refusal. Patient will be divided randomly using computer generated number and concealed using sequentially numbered, sealed opaque enevelop technique into two equal groups-

Group N: will receive normal saline as maintenance fluid

Group B: will receive balanced crystalloids as maintenance fluid

All patients will follow the ICU protocol for head injury management. A drug which affects the fluid and electrolyte status like mannitol, Diuretics etc will be recorded in both groups. Acid base status & electrolyle will be recorded on day1 , 3, 5, 7, 14 and on every 5 days there after till icu stay.

Result

Acid base status and electrolyte levels are better maintained in balanced crystalloid groups than normal saline and his was  statically significant on day 14. No significant difference in 28 days mortality between two groups.

Conclusion

Balanced craystalloids  can be used in traumatic brain injury patients. Further large multicentric study required to evaluate their effects on intracranial pressure.

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
盲法
Participant, Investigator and Outcome Assessor Blinded

入排标准

年龄范围
18.00 Year(s) 至 60.00 Year(s)(—)
性别
All

入选标准

  • Patient with nonoperative head injury admitted to intensive care unit within 24hr of injury.

排除标准

  • 1.Patient/relative refusal.
  • 2.Patient baseline electrolytes are outside normal range.
  • 3.Patient on inotropic support.
  • 4.Patient with any systemic illness like Diabetes, Hypertension etc.
  • 5.Patient with end stage organ damage e.g. hepatic, renal or cardiovascular disorder.
  • 6.Patients with polytrauma.

结局指标

主要结局

Acid base and electrolyte status

时间窗: day 1, 3, 5, 7, 14

次要结局

  • Duration of icu stay(28 days mortality)

研究者

发起方
Institute of Medical Sciences
申办方类型
Government medical college

研究点 (1)

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