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Mannitol Versus Supportive Care in Ciguatera Fish Poisoning

Primary Purpose

Ciguatoxin

Status
Unknown status
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Mannitol
Sponsored by
University of South Florida
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ciguatoxin focused on measuring mannitol, treatment

Eligibility Criteria

18 Years - 100 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    No Intervention

    Experimental

    Arm Label

    Control

    Investigational

    Arm Description

    Patients will receive supportive care measures.

    Patients will receive 500mL of 20% mannitol

    Outcomes

    Primary Outcome Measures

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

    Secondary Outcome Measures

    Full Information

    First Posted
    October 6, 2015
    Last Updated
    October 6, 2015
    Sponsor
    University of South Florida
    Collaborators
    Florida Poison Control Center
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02570971
    Brief Title
    Mannitol Versus Supportive Care in Ciguatera Fish Poisoning
    Official Title
    Mannitol Versus Supportive Care in Ciguatera Fish Poisoning: A Randomized Control Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2015
    Overall Recruitment Status
    Unknown status
    Study Start Date
    October 2015 (undefined)
    Primary Completion Date
    June 2018 (Anticipated)
    Study Completion Date
    undefined (undefined)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    University of South Florida
    Collaborators
    Florida Poison Control Center

    4. Oversight

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Ciguatoxin
    Keywords
    mannitol, treatment

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Single Group Assignment
    Masking
    ParticipantCare ProviderInvestigator
    Allocation
    Randomized
    Enrollment
    200 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Control
    Arm Type
    No Intervention
    Arm Description
    Patients will receive supportive care measures.
    Arm Title
    Investigational
    Arm Type
    Experimental
    Arm Description
    Patients will receive 500mL of 20% mannitol
    Intervention Type
    Drug
    Intervention Name(s)
    Mannitol
    Primary Outcome Measure Information:
    Title
    Symptom score
    Description
    Covers a variety of neurological and gastrointestinal symptoms on a 0-4 score
    Time Frame
    24 hours

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    100 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: History consistent with ciguatera poisoning Exclusion Criteria: Minors pregnant patients those unable to give consent severe congestive heart failure or renal failure
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Michael Butterfield, MD MS MPH
    Email
    mbutterfield@health.usf.edu

    12. IPD Sharing Statement

    Learn more about this trial

    Mannitol Versus Supportive Care in Ciguatera Fish Poisoning

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