Mannitol Versus Supportive Care in Ciguatera Fish Poisoning

Mannitol Versus Supportive Care in Ciguatera Fish Poisoning: A Randomized Control Trial

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.

Study Overview

• Status: Unknown
• Conditions: Ciguatoxin
• Intervention / Treatment: Drug: Mannitol

• Study Type: Interventional
• Enrollment (Anticipated): 200
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Michael Butterfield, MD MS MPH; Email: mbutterfield@health.usf.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Symptom score	Covers a variety of neurological and gastrointestinal symptoms on a 0-4 score	24 hours

Collaborators and Investigators

• Sponsor: University of South Florida
• Collaborators: Florida Poison Control Center

Study record dates

Study Major Dates

• Study Start: October 1, 2015
• Primary Completion (Anticipated): June 1, 2018
• Study Completion: December 6, 2022

Study Registration Dates

• First Submitted: October 6, 2015
• First Submitted That Met QC Criteria: October 6, 2015
• First Posted (Estimate): October 7, 2015

Study Record Updates

• Last Update Posted (Estimate): October 7, 2015
• Last Update Submitted That Met QC Criteria: October 6, 2015
• Last Verified: October 1, 2015

More Information

Terms related to this study

• Keywords: mannitol; treatment
• Additional Relevant MeSH Terms: Chemically-Induced Disorders; Foodborne Diseases; Poisoning; Ciguatera Poisoning; Physiological Effects of Drugs; Natriuretic Agents; Diuretics, Osmotic; Diuretics; Mannitol
• Other Study ID Numbers: CITX-2015

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No