Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 1 for:    pilboutox
Previous Study | Return to List | Next Study

PilBouTox® Project: Button Battery Poisoning From Data Collected by French Poison Control Centres (PILBOUTOX)

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: NCT03708250
Recruitment Status : Completed
First Posted : October 17, 2018
Last Update Posted : October 18, 2018
Sponsor:
Information provided by (Responsible Party):
University Hospital, Bordeaux

Brief Summary:
Button batteries are found in all householders and can be responsible for poisoning, in particular in children. Unexpected complications and death in children who have ingested button battery have been published for over twenty years in medical literature. There are many questions related to the treatment that remain unanswered, because some data are missing in previously published studies. The main objective of this study is to precisely describe poisoning cases by button battery in order to propose a better management

Condition or disease
Button Battery Poisoning

Detailed Description:
Button batteries are found in all householders and can be responsible for poisoning, in particular in children. Unexpected complications and death in children who have ingested button battery have been published for over twenty years in medical literature. The most serious cases are those related to the ingestion of button cells, especially in children, when the battery gets stuck in the esophagus. Poison control centres, as well as addictovigilance centres, are regularly called upon for serious poisoning resulting in hospitalization, for which precisely description is most often missing or difficult to obtain and limits the efficiency of the management of these poisonings. So there are many questions related to the treatment that remain unanswered, because some data are missing in previously published studies. For example, in many cases, there is a lack of detail of initial symptoms, delays between symptoms and completion of further tests, follow-ups… A prospective and descriptive study about button battery poisoning performed on data collected by French PCC will be conducted between the 1st June of 2016 and the 31 May of 2018: any call in a PCC that occurred during the period studied and concerning an exposure to a button cell regardless of the route of exposure, the age of the patient, and its symptomatology will be included. The following data will be taken : severe complication, need for surgery, length of hospital stay, death, risk factors concerning the battery (size, voltage), abnormalities at the first fibroscopy.

Layout table for study information
Study Type : Observational
Actual Enrollment : 510 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: PilBouTox® Project: Prospective and Descriptive Study About Button Battery Poisoning Performed on Data Collected by French Poison Control Centres (PCC)
Actual Study Start Date : June 1, 2016
Actual Primary Completion Date : May 31, 2018
Actual Study Completion Date : May 31, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Poisoning




Primary Outcome Measures :
  1. occurrence of a serious complication [ Time Frame: Baseline ]
    occurrence of a serious complication


Secondary Outcome Measures :
  1. Need for surgery [ Time Frame: baseline ]
    Need for surgery

  2. Length of hospital stay [ Time Frame: baseline ]
    Length of hospital stay

  3. Death [ Time Frame: baseline ]
    Death

  4. Battery Size [ Time Frame: baseline ]
    Battery Size

  5. Battery Voltage [ Time Frame: baseline ]
    Battery Voltage

  6. Presence of Lying [ Time Frame: baseline ]
    Presence of Lying

  7. Length of Insertion [ Time Frame: baseline ]
    Length of Insertion

  8. Abnormalities at First Fibroscopy [ Time Frame: baseline ]
    Abnormalities at First Fibroscopy



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Anyone who calls for exposure to a button cell regardless of the route of exposure, the age of the patient, and its symptomatology.
Criteria

Inclusion Criteria:

Any call that occurred during the period studied in a Poison Control Centre and concerning an exposure to a button cell regardless of the route of exposure, the age of the patient, and its symptomatology.

Exclusion Criteria:

Animal cases


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): NCT03708250


Locations
Layout table for location information
France
Centre Anti Poison
Angers, France
Centre Anti Poison
Lille, France
Centre Anti Poison
Lyon, France
Centre Anti Poison
Marseille, France
Centre Anti Poison
Nancy, France
Centre Anti Poison
Paris, France
Centre Anti Poison
Strasbourg, France
Centre Anti Poison
Toulouse, France
Sponsors and Collaborators
University Hospital, Bordeaux

Layout table for additonal information
Responsible Party: University Hospital, Bordeaux
ClinicalTrials.gov Identifier: NCT03708250     History of Changes
Other Study ID Numbers: CHUBX 2018/54
First Posted: October 17, 2018    Key Record Dates
Last Update Posted: October 18, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University Hospital, Bordeaux:
button battery
intoxication
oesophageal necrosis
Poison Control Centre
Poisoning

Additional relevant MeSH terms:
Layout table for MeSH terms
Poisoning
Chemically-Induced Disorders