A Randomized, Blinded, Placebo-Controlled Phase 2B Clinical Trial to Compare the Efficacy of Different Combinations of Sodium Chloride and Sodium Acetate IV Fluids Along With Standard of Care Treatment in Acute Stroke Patients.
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- hyperchloremia into one occurrence or two or more occurrences within first 72 hours hyperchloremia"
研究概览
简要总结
Hypothesis:
Hyper chloremia is associated with poor outcome in Intracerebral Hemorrhage (ICT). Hyperchloremia is defined as serum chloride level of 110mmol/L or greater. This clinical study is assuming that, by increasing the ratio of Sodium-acetate to Sodium-chloride solutions in IV treatment, the incidence of Hyperchloremia can be lowered significantly. This result can be demonstrated by measuring serum chloride levels at Baseline, 24Hr, 48Hr and 72 Hours' time intervals and compare them between the three treatment and one Control arm.
Intervention (drug/biologic/device/behavioral):
Phase 2-dose finding Patients will be enrolled in the study and randomized into one of the four study treatment arms(target fluid administration rate 1 ml/kg/hour) initiated within 12 hours. IVF will be prepared in the main hospital pharmacy.
- Sodium chloride (0.9%) referred as 0.9% NaCl for 72 hours post symptom onset (60-72 hourspost randomization);
- Sodium chloride (0.9%) and sodium acetate (0.9%) mixture 3:1 ratio for 72 hours post symptom onset (60-72 hours post randomization);
- Sodium chloride (0.9%) and sodium acetate (0.9%) mixture 2:1 ratio for 72 hours post symptom onset (60-72 hours post randomization);
- Sodium chloride (0.9%) and sodium acetate (0.9%) mixture 1:1 ratio for 72 hours post symptom onset (60-72 hours post randomization).
详细描述
Background and Rational:
Acute stroke and intracerebral hemorrhages are most common admissions in neurological intensive care units. Proper management of these diseases helps to achieve better outcomes and reduce the burden on family and society. Proper volumes and concentration of intravenous fluids maintains sufficient blood flow to the brain. Several studies have demonstrated a relationship between hyperchloremia and death or disability observed in neurological diseases particularly ischemic stroke and ICH. The association between hyperchloremia and death or disability in patients with ischemic stroke and ICH is independent from the effect of patients' age or stroke severity. Hyperchloremia is also associated with occurrence of Acute Kidney injury in patients with subarachnoid hemorrhage and AKI was associated with higher mortality.
Hyperchloremia may induce metabolic acidosis which can results in intra- and extra- cellular acidosis in the brain leading to cytotoxicity via activation of enzymes and alteration in ionic movements and dysfunction of aquaporin-4 receptor leading to edema formation (9) and neural excitotoxicity.
Hyperchloremia may also augment pro-inflammatory response and modification of neutrophil and myeloperoxidase activity. Therefore, avoidance of hyperchloremia may be a therapeutic target in reducing death or disability among patients with ischemic stroke or ICH. The most effective strategy for reducing hyperchloremia is to reduce the chloride load through IV fluids.
A pilot study is proposed to identify the best" dose (ratio) of sodium chloride (0.9%) and sodium acetate (0.9%) mixture for reduction of hyperchloremia by using chloride efficient fluids in patients with acute stroke initiated within 12 hours of symptom onset and continued for 72hours.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
A Randomized, Blinded, Placebo-Controlled phase 2B clinical Trial
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 years or older
- •Onset of new neurological deficits within 24 hours
- •NIHSS score of 4 or more
- •GCS score of 5 or more
- •CT scan demonstrates intraparenchymal hematoma with manual hematoma volume measurement <60 cm3 OR CT scan consistent with Ischemic Stroke
排除标准
- •received Intravenous fluids for greater than 8 hours
- •Baseline Serum Chloride is greater than 110 mmol/L
- •Acute Kidney Injury
- •History of Chronic Renal Failure
- •Requirement of Hemodialysis or Peritoneal Dialyses Prior to Randomization
研究组 & 干预措施
Normal saline arm
Sodium chloride (0.9%) referred as 0.9% NaCl for 72 hours post symptom onset (60-72 hourspost randomization);
干预措施: Sodium Chloride 0.9% infusion alone or in combination with Sodim acetate with normal saline in a ratio 1;1, 2;1 and 3;1 (Drug)
normal saline sodium acetate 3;1
Sodium chloride (0.9%) and sodium acetate (0.9%) mixture 3:1 ratio for 72 hours post symptom onset (60-72 hours post randomization
干预措施: Sodium Chloride 0.9% infusion alone or in combination with Sodim acetate with normal saline in a ratio 1;1, 2;1 and 3;1 (Drug)
normal saline sodium acetate 2;1
Sodium chloride (0.9%) and sodium acetate (0.9%) mixture 2:1 ratio for 72 hours post symptom onset (60-72 hours post randomization);
干预措施: Sodium Chloride 0.9% infusion alone or in combination with Sodim acetate with normal saline in a ratio 1;1, 2;1 and 3;1 (Drug)
normal saline sodium acetate 1;1
Sodium chloride (0.9%) and sodium acetate (0.9%) mixture 1:1 ratio for 72 hours post symptom onset (60-72 hours post randomization).
干预措施: Sodium Chloride 0.9% infusion alone or in combination with Sodim acetate with normal saline in a ratio 1;1, 2;1 and 3;1 (Drug)
结局指标
主要结局
hyperchloremia into one occurrence or two or more occurrences within first 72 hours hyperchloremia"
时间窗: 72 hours
hyperchloremia into one occurrence or two or more occurrences within first 72 hours hyperchloremia"
次要结局
未报告次要终点
研究者
MUHAMMAD WASAY
professor
Aga Khan University