Clinical trial NCT03658902: Retrospective Epidemiological Study on Botulism in Intensive Care Units in France
Official title: Retrospective Epidemiological Study on Patients Admitted for Botulism Poisoning in Intensive Care Units in France
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Botulism; Poisoning
Keywords: Botulism
Intensive Care
Lead sponsor: Centre Hospitalier le Mans
Sponsor class: OTHER
First posted: 2018-09-06
Enrollment: 52
Sex: ALL
Minimum age (years): 15
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients 15 years of age or older with a clinical diagnosis of botulism.

Brief summary: Botulism poisoning is a rare but serious illness. Because of it's low incidence, it is not well known by physicians. Most studies describing botulism date back to the last century and do not take into account recent advances in intensive care.

The objective of this study is to describe the clinical course, interventions and outcomes of patients with severe botulism poisoning requiring a hospitalisation in an intensive care or high dependancy unit.


Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of botulism
* Admission in an intensive care or high dependancy unit

Exclusion Criteria:

* None

Primary outcomes:
measure: Survival
timeFrame: 2000 to 2017
Secondary outcomes:
measure: Age
timeFrame: 2000 to 2017
measure: Weight
timeFrame: 2000 to 2017
measure: Height
timeFrame: 2000 to 2017
measure: History of motor impairment measured by the modified Rankin scale
timeFrame: 2000 to 2017
measure: History of heart failure measured by the NYHA (New York Health Association) score
timeFrame: 2000 to 2017
measure: History of chronic respiratory failure: use of daily oxygen therapy AND/OR non invasive ventilation
timeFrame: 2000 to 2017
measure: History of chronic kidney disease measured by the glomerular filtration rate.
timeFrame: 2000 to 2017
measure: History of cirrhosis as measured by the CHILD-PUGH score.
timeFrame: 2000 to 2017
measure: Source of the contamination
timeFrame: 2000 to 2017
measure: Isolated or multiple cases
timeFrame: 2000 to 2017
measure: Botulinum Toxin type if identified
timeFrame: 2000 to 2017
measure: Severity at ICU admission
timeFrame: 2000 to 2017
measure: Mechanical ventilation requirement
timeFrame: 2000 to 2017
measure: Invasive mechanical ventilation requirement
timeFrame: 2000 to 2017
measure: Non invasive mechanical ventilation requirement
timeFrame: 2000 to 2017
measure: Whether or not the patient required a tracheotomy during his ICU stay.
timeFrame: 2000 to 2017
measure: Enteral or parenteral nutritional support
timeFrame: 2000 to 2017
measure: Number of days of vasopressor support
timeFrame: 2000 to 2017
measure: Acute kidney injury measured by maximum serum creatinine during ICU stay.
timeFrame: 2000 to 2017
measure: Severe liver failure
timeFrame: 2000 to 2017
measure: Whether or not antitoxin was administered to the patient.
timeFrame: 2000 to 2017
measure: Whether or not guanidine was administered during ICU stay
timeFrame: 2000 to 2017
measure: Length of stay.
timeFrame: 2000 to 2017
measure: Healthcare acquired infection
timeFrame: 2000 to 2017
measure: Mechanical ventilation related complications.
timeFrame: 2000 to 2017
measure: Bedrest complications: bedsores
timeFrame: 2000 to 2017
measure: Bedrest complications: thrombo-embolic complications
timeFrame: 2000 to 2017
measure: Disability at ICU discharge
timeFrame: 2000 to 2017
measure: Disability at hospital discharge
timeFrame: 2000 to 2017
measure: Last known disability
timeFrame: 2000 to 2017
measure: Survival at hospital discharge
timeFrame: 2000 to 2017
Other outcomes:
Locations:
Study officials:
affiliation: Centre Hospitalier le Mans
name: Christophe Guitton, MD
role: PRINCIPAL_INVESTIGATOR
References: