Mannitol Versus Supportive Care in Ciguatera Fish Poisoning: A Randomized Control Trial
试验速览
- 阶段
- 3 期
- 入组人数
- 200
- 主要终点
- Symptom score
研究概览
简要总结
Ciguatera poisoning, caused by the ingestion of ciguatoxin-containing fish, is a global public health concern. In the US, the vast majority of ciguatera poisonings occur in Florida, followed by Hawaii and California. Equipoise exists in the medical literature regarding the effectiveness of mannitol therapy in treatment of ciguatera poisoning. While there are many case reports attesting to its utility, the only randomized control trial (RCT) comparing mannitol therapy with supportive care failed to show any significant benefit from mannitol treatment for a variety of clinical outcomes. Investigators therefore propose a second, larger RCT to test this question.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •History consistent with ciguatera poisoning
排除标准
- •pregnant patients
- •those unable to give consent
- •severe congestive heart failure or renal failure
研究组 & 干预措施
Investigational
Patients will receive 500mL of 20% mannitol
干预措施: Mannitol (Drug)
结局指标
主要结局
Symptom score
时间窗: 24 hours
Covers a variety of neurological and gastrointestinal symptoms on a 0-4 score
次要结局
未报告次要终点