MedPath

Mannitol Versus Supportive Care in Ciguatera Fish Poisoning

Phase 3
Conditions
Ciguatoxin
Interventions
Registration Number
NCT02570971
Lead Sponsor
University of South Florida
Brief Summary

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.

Detailed Description

Not available

Recruitment & Eligibility

Status
UNKNOWN
Sex
All
Target Recruitment
200
Inclusion Criteria
  • History consistent with ciguatera poisoning
Exclusion Criteria
  • Minors
  • pregnant patients
  • those unable to give consent
  • severe congestive heart failure or renal failure

Study & Design

Study Type
INTERVENTIONAL
Study Design
SINGLE_GROUP
Arm && Interventions
GroupInterventionDescription
InvestigationalMannitolPatients will receive 500mL of 20% mannitol
Primary Outcome Measures
NameTimeMethod
Symptom score24 hours

Covers a variety of neurological and gastrointestinal symptoms on a 0-4 score

Secondary Outcome Measures
NameTimeMethod
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