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Mannitol Versus Supportive Care in Ciguatera Fish Poisoning

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02570971
Recruitment Status : Unknown
Verified October 2015 by University of South Florida.
Recruitment status was:  Not yet recruiting
First Posted : October 7, 2015
Last Update Posted : October 7, 2015
Sponsor:
Collaborator:
Florida Poison Control Center
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Ciguatoxin Drug: Mannitol Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Mannitol Versus Supportive Care in Ciguatera Fish Poisoning: A Randomized Control Trial
Study Start Date : October 2015
Estimated Primary Completion Date : June 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Poisoning
Drug Information available for: Mannitol

Arm Intervention/treatment
No Intervention: Control
Patients will receive supportive care measures.
Experimental: Investigational
Patients will receive 500mL of 20% mannitol
Drug: Mannitol



Primary Outcome Measures :
  1. Symptom score [ Time Frame: 24 hours ]
    Covers a variety of neurological and gastrointestinal symptoms on a 0-4 score



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02570971


Contacts
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Contact: Michael Butterfield, MD MS MPH mbutterfield@health.usf.edu

Sponsors and Collaborators
University of South Florida
Florida Poison Control Center
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Responsible Party: University of South Florida
ClinicalTrials.gov Identifier: NCT02570971    
Other Study ID Numbers: CITX-2015
First Posted: October 7, 2015    Key Record Dates
Last Update Posted: October 7, 2015
Last Verified: October 2015
Keywords provided by University of South Florida:
mannitol
treatment
Additional relevant MeSH terms:
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Poisoning
Ciguatera Poisoning
Chemically-Induced Disorders
Foodborne Diseases
Mannitol
Diuretics, Osmotic
Diuretics
Natriuretic Agents
Physiological Effects of Drugs