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Retrospective Epidemiological Study on Botulism in Intensive Care Units in France

Retrospective Epidemiological Study on Patients Admitted for Botulism Poisoning in Intensive Care Units in France

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03658902
Acronym
BotuREA
Enrollment
52
Registered
2018-09-06
Start date
2000-01-01
Completion date
2018-08-15
Last updated
2026-07-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Botulism; Poisoning

Keywords

Botulism, Intensive Care

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.

Interventions

None listed

Sponsors

Centre Hospitalier le Mans
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
15 Years to No maximum

Inclusion criteria

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

Exclusion criteria

* None

Design outcomes

Primary

MeasureTime frameDescription
Survival2000 to 2017Proportion of patients alive at ICU discharge

Secondary

MeasureTime frameDescription
Age2000 to 2017Mean age of recruited patients
Weight2000 to 2017Mean weight of recruited patients
Height2000 to 2017Mean Height of recruited patients
History of motor impairment measured by the modified Rankin scale2000 to 2017History of neurological disorder with motor impairment before the poisoning, measured by the Modified Rankin Scale (0 to 6, 0 being no symptoms and 6 being deceased).
History of heart failure measured by the NYHA (New York Health Association) score2000 to 2017History of heart failure before the poisoning, measured by the NYHA (New York health Association) dyspnoea score (1 to 4, 1 being no symptoms and no limitation in daily physical activity, 4 being severe symptoms even at rest).
History of chronic respiratory failure: use of daily oxygen therapy AND/OR non invasive ventilation2000 to 2017Chronic respiratory failure defined by the use of chronic oxygen therapy AND/OR daily non invasive ventilation.
History of chronic kidney disease measured by the glomerular filtration rate.2000 to 2017History of chronic kidney disease before the poisoning, defined as a glomerular filtration rate \< 60 mL/min/1.73m for more than 3 months OR chronic dialysis.
History of cirrhosis as measured by the CHILD-PUGH score.2000 to 2017Presence or absence of Cirrhosis, as measured by the CHILD-PUGH score (class A, B or C, A predicting a one year survival probability of 100%, C predicting a one year survival probability of 45%).
Source of the contamination2000 to 2017Suspected origin of the toxin: food poisoning, dermal wound, intravenous drug use, intestinal colonisation by Clostridium sp. or unknown.
Isolated or multiple cases2000 to 2017Whether the poisoning is isolated or one of multiple cases originating from the same source.
Botulinum Toxin type if identified2000 to 2017Botulinum toxin type if identified (A,B,C,D,E,F,G or H type toxin).
Severity at ICU admission2000 to 2017Simplified acute physiology score 2 (SAPS 2) at admission in the ICU: from 0 to 163, with 0 predicting a mortality risk of 0% and 163 of 100%.
Mechanical ventilation requirement2000 to 2017Whether the patient required or not mechanical ventilation during his ICU stay
Invasive mechanical ventilation requirement2000 to 2017Whether the patient required or not invasive mechanical ventilation during his ICU stay
Non invasive mechanical ventilation requirement2000 to 2017Whether the patient required or not non invasive mechanical ventilation during his ICU stay
Whether or not the patient required a tracheotomy during his ICU stay.2000 to 2017Whether the patient required a tracheotomy during his ICU stay
Enteral or parenteral nutritional support2000 to 2017Whether the patient required or not enteral or parenteral nutritional support during his ICU stay
Number of days of vasopressor support2000 to 2017Number of days the patient required vasopressor support during his ICU stay
Acute kidney injury measured by maximum serum creatinine during ICU stay.2000 to 2017Whether the patient developped an acute kidney injury during his ICU stay: measured by maximum serum creatinine during ICU stay in µmol/L.
Severe liver failure2000 to 2017Whether the patient developped an acute severe liver failure during his ICU stay, defined as a prothrombin time less than 50% due to liver failure.
Whether or not antitoxin was administered to the patient.2000 to 2017Whether botulinum antitoxin was administered.
Whether or not guanidine was administered during ICU stay2000 to 2017Whether guanidine was administered as a treatment for the botulinum poisoning.
Length of stay.2000 to 2017Number of hospitalisation days in the ICU.
Healthcare acquired infection2000 to 2017Whether the patient acquired a healthcare related infection during his stay in the ICU.
Mechanical ventilation related complications.2000 to 2017Whether the patient had any mechanical ventilation related complications during his stay in the ICU.
Bedrest complications: bedsores2000 to 2017Whether the patient acquired bedsores during his ICU stay.
Bedrest complications: thrombo-embolic complications2000 to 2017Whether the patient acquired thrombo-embolic complications (deep vein thrombosis or pulmonary embolism) during his ICU stay.
Disability at ICU discharge2000 to 2017Modified Rankin scale at ICU discharge, from 0 to 6, with 0 being asymptomatic and 6 being death.
Disability at hospital discharge2000 to 2017Modified Rankin scale at hospital discharge, from 0 to 6, with 0 being asymptomatic and 6 being death.
Last known disability2000 to 2017Last known modified Rankin scale, from 0 to 6, with 0 being asymptomatic and 6 being death.
Survival at hospital discharge2000 to 2017Proportion of patients alive at hospital discharge

Countries

France

Contacts

PRINCIPAL_INVESTIGATORChristophe Guitton, MD

Centre Hospitalier le Mans

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 2, 2026