Comparative Efficacy and Safety of 3percent Hypertonic Saline Plus Mannitol versus 3percent Hypertonic Saline Alone in Lowering Intracranial Pressure based on Optic Nerve Sheath Diameter in Stroke Patients
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 142
- 试验地点
- 1
- 主要终点
- To compare the reduction in ONSD in stroke patients receiving 3% hypertonic saline alone vs. those receiving 3% hypertonic saline with mannitol.
研究概览
简要总结
Mannitol reduces cerebral Edema by acting as an osmotic diuretic, which pulls water from the brain parenchyma into the vascular compartment and lowers ICP. Nevertheless, electrolyte imbalances and hypovolemia may result from its diuretic action. By raising serum osmolality and encouraging water to migrate from the intracellular to the extracellular region, hypertonic saline (3percent NaCl) lessens cerebral Edema. Additionally, it increases cerebral perfusion pressure and plasma volume without causing appreciable diuresis. Because of the continuity of the subarachnoid space, the optic nerve sheath diameter (ONSD) reflects intracranial pressure.
• Null Hypothesis There is no difference in efficacy or safety between the combination of 3percent hypertonic saline plus mannitol and 3% hypertonic saline alone in reducing intracranial pressure in stroke patients. • Alternative Hypothesis The combination of 3percent hypertonic saline and mannitol is more effective and equally safe compared to 3% hypertonic saline alone in reducing intracranial pressure in stroke patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 75.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Adult patients who are 18 years of age or older.
- •Acute stroke diagnosis (ischemic or haemorrhagic) confirmed by brain imaging with CT or MRI.
- •Clinical or radiological indications of high intracranial pressure (ICP): These include symptoms including cerebral Edema, papilledema, midline shift, diminished consciousness, obliteration of the basal cisterns, and ONSD greater than 5.0 mm.
- •Hemodynamically stable upon enrolment: Systolic blood pressure of 90 mmHg or above without inotropic assistance.
- •Based on clinical assessment, hyperosmolar treatment is anticipated to be necessary as part of routine ICP management.
- •Consent from the patient or their duly appointed representative
- •GCS score between 6-13.
排除标准
- 未提供
结局指标
主要结局
To compare the reduction in ONSD in stroke patients receiving 3% hypertonic saline alone vs. those receiving 3% hypertonic saline with mannitol.
时间窗: baseline , 1 hour, 6 hour , 12 hour and 24 hour
次要结局
- • To evaluate clinical improvement using tools like the NIH Stroke Scale & Glasgow Coma Scale.(• To compare the incidence of adverse effects (renal dysfunction, electrolyte imbalance, rebound, ICP etc.) between the group.)
研究者
Dr Keshav Rajput
AIIMS JODHPUR