Mannitol Versus Supportive Care in Ciguatera Fish Poisoning

NCT ID: NCT02570971

Last Updated: 2015-10-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-10-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Ciguatoxin

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Control

Patients will receive supportive care measures.

Group Type NO_INTERVENTION

No interventions assigned to this group

Investigational

Patients will receive 500mL of 20% mannitol

Group Type EXPERIMENTAL

Mannitol

Intervention Type DRUG

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Mannitol

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* History consistent with ciguatera poisoning

Exclusion Criteria

* Minors
* pregnant patients
* those unable to give consent
* severe congestive heart failure or renal failure
Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Florida Poison Control Center

OTHER

Sponsor Role collaborator

University of South Florida

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Michael Butterfield, MD MS MPH

Role: CONTACT

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

CITX-2015

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Exogenous Ketone Esters for Drug Resistant Epilepsy
NCT05670847 RECRUITING PHASE2/PHASE3
Ketogenic Diet Program for Epilepsy
NCT02497105 COMPLETED NA
Effectiveness of Ketogenic Diet in MELAS Syndrome
NCT06013397 NOT_YET_RECRUITING NA
Quetiapine Treatment for Pediatric Delirium
NCT03572257 WITHDRAWN PHASE2/PHASE3
Ketogenic Diet Drink Study
NCT03196271 COMPLETED NA