Retrospective Epidemiological Study on Botulism in Intensive Care Units in France
- Conditions
- Botulism; Poisoning
- Registration Number
- NCT03658902
- Lead Sponsor
- Centre Hospitalier le Mans
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 52
- Clinical diagnosis of botulism
- Admission in an intensive care or high dependancy unit
- None
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Survival 2000 to 2017 Proportion of patients alive at ICU discharge
- Secondary Outcome Measures
Name Time Method Height 2000 to 2017 Mean Height of recruited patients
History of motor impairment measured by the modified Rankin scale 2000 to 2017 History 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).
Age 2000 to 2017 Mean age of recruited patients
Weight 2000 to 2017 Mean weight of recruited patients
History of heart failure measured by the NYHA (New York Health Association) score 2000 to 2017 History 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 ventilation 2000 to 2017 Chronic 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 2017 History 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 2017 Presence 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 contamination 2000 to 2017 Suspected origin of the toxin: food poisoning, dermal wound, intravenous drug use, intestinal colonisation by Clostridium sp. or unknown.
Isolated or multiple cases 2000 to 2017 Whether the poisoning is isolated or one of multiple cases originating from the same source.
Botulinum Toxin type if identified 2000 to 2017 Botulinum toxin type if identified (A,B,C,D,E,F,G or H type toxin).
Severity at ICU admission 2000 to 2017 Simplified 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 requirement 2000 to 2017 Whether the patient required or not mechanical ventilation during his ICU stay
Invasive mechanical ventilation requirement 2000 to 2017 Whether the patient required or not invasive mechanical ventilation during his ICU stay
Non invasive mechanical ventilation requirement 2000 to 2017 Whether 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 2017 Whether the patient required a tracheotomy during his ICU stay
Enteral or parenteral nutritional support 2000 to 2017 Whether the patient required or not enteral or parenteral nutritional support during his ICU stay
Number of days of vasopressor support 2000 to 2017 Number of days the patient required vasopressor support during his ICU stay
Acute kidney injury measured by maximum serum creatinine during ICU stay. 2000 to 2017 Whether the patient developped an acute kidney injury during his ICU stay: measured by maximum serum creatinine during ICU stay in µmol/L.
Severe liver failure 2000 to 2017 Whether 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 2017 Whether botulinum antitoxin was administered.
Whether or not guanidine was administered during ICU stay 2000 to 2017 Whether guanidine was administered as a treatment for the botulinum poisoning.
Healthcare acquired infection 2000 to 2017 Whether the patient acquired a healthcare related infection during his stay in the ICU.
Mechanical ventilation related complications. 2000 to 2017 Whether the patient had any mechanical ventilation related complications during his stay in the ICU.
Bedrest complications: bedsores 2000 to 2017 Whether the patient acquired bedsores during his ICU stay.
Length of stay. 2000 to 2017 Number of hospitalisation days in the ICU.
Bedrest complications: thrombo-embolic complications 2000 to 2017 Whether the patient acquired thrombo-embolic complications (deep vein thrombosis or pulmonary embolism) during his ICU stay.
Disability at ICU discharge 2000 to 2017 Modified Rankin scale at ICU discharge, from 0 to 6, with 0 being asymptomatic and 6 being death.
Disability at hospital discharge 2000 to 2017 Modified Rankin scale at hospital discharge, from 0 to 6, with 0 being asymptomatic and 6 being death.
Last known disability 2000 to 2017 Last known modified Rankin scale, from 0 to 6, with 0 being asymptomatic and 6 being death.
Survival at hospital discharge 2000 to 2017 Proportion of patients alive at hospital discharge