Mannitol Versus Supportive Care in Ciguatera Fish Poisoning

University of South Florida

Status and phase: Unknown; Phase 3

Conditions: Ciguatoxin

Treatments: Drug: Mannitol

Study type: Interventional

Funder types: Other

Identifiers

NCT02570971

CITX-2015

Details and patient eligibility

About

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.

Enrollment: 200 estimated patients

Sex: All

Ages: 18 to 100 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• History consistent with ciguatera poisoning

Exclusion criteria

• Minors
• pregnant patients
• those unable to give consent
• severe congestive heart failure or renal failure

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Triple Blind

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200 participants in 2 patient groups

Control

No Intervention group

Description:

Patients will receive supportive care measures.

Investigational

Experimental group

Description:

Patients will receive 500mL of 20% mannitol

Treatment:

Drug: Mannitol