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临床试验/CTRI/2025/02/080638
CTRI/2025/02/080638尚未招募不适用

3% Hypertonic saline induced changes in Optic Nerve Sheath Diameter (ONSD) and its correlation with Transcranial colour coded Duplex (TCCD) parameters in patients with moderate to severe Traumatic Brain Injury (TBI): A prospective observational study.

All India institute of medical sciences Jodhpur1 个研究点 分布在 1 个国家目标入组 85 人开始时间: 2025年2月17日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
85
试验地点
1
主要终点
To assess the correlation between change in ONSD and change in TCCD parameters following 3% hypertonic saline therapy in patients with moderate to severe traumatic brain injury TBI.

研究概览

简要总结

After CTRI approval, our study will enroll patients with moderate to severe traumatic brain injury to observe the 3% hypertonic saline-induced changes in optic nerve sheath diameter (ONSD) and transcranial color-coded Doppler (TCCD) parameters and assess the correlation between them.

The primary objective is to establish a correlation between changes in ONSD and TCCD parameters following hypertonic saline therapy. Secondary objective is to assess the correlation between clinical improvement (change in GCS) with changes in TCCD parameters and ONSD in patients with moderate to severe TBI following hypertonic saline. To assess the effects of 3% hypertonic saline administration on electrolyte disturbances and hemodynamic parameters in patients with TBI. To evaluate clinical outcomes including length of ICU stay, length of ventilatory stay, incidence of AKI, total hospital length of stay, and mortality rates.

Data will be collected at baseline (before therapy) at the time of ICU admission, 10 minutes post-therapy, 1 hour post-therapy, and daily for 5 days or until the administration of hypertonic saline therapy, whichever is earlier. Clinical outcomes will be noted until hospital discharge or the date of death in the hospital.

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 80.00 Year(s)(—)
性别
All

入选标准

  • 1.Adult patient aged 18yrs and above 2.admitted in ICU 3.Diagnosed with Moderate/severe TBI requiring hypertonic saline therapy.

排除标准

  • 1.patient refusal 2.preexisting optic nerve disorders 3.spontaneous intracranial haemorrhage,stroke 4.skull fractures 5.hemodynamic instability 6.brain stem death.

结局指标

主要结局

To assess the correlation between change in ONSD and change in TCCD parameters following 3% hypertonic saline therapy in patients with moderate to severe traumatic brain injury TBI.

时间窗: Baseline,10mins and 1hr after hypertonic saline administration from ICU admission till day 5 of ICU or continuation of hypertonic saline therapy whichever is earlier

次要结局

  • 1.To assess the correlation between changes in TCCD parameters and clinical improvement [change in Glasgow Coma Scale (GCS)] in patients with moderate to severe TBI following 3% hypertonic saline therapy.(2.To assess the correlation between changes in ONSD and clinical improvement (change in GCS) in patients with moderate to severe TBI following 3% hypertonic saline therapy.)

研究者

发起方
All India institute of medical sciences Jodhpur
申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Pharanitharan

All India institute of medical sciences Jodhpur

研究点 (1)

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