Centre Hospitalier Le Mans
Le Mans, 72000, France
NCT Number: NCT03658902
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.
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Notify Me15 year and older
All sexes
Observational
Le Mans, 72000, France
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: 2000 to 2017
Proportion of patients alive at ICU discharge
Time frame: 2000 to 2017
Mean age of recruited patients
Time frame: 2000 to 2017
Mean weight of recruited patients
Time frame: 2000 to 2017
Mean Height of recruited patients
Time frame: 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).
Time frame: 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).
Time frame: 2000 to 2017
Chronic respiratory failure defined by the use of chronic oxygen therapy AND/OR daily non invasive ventilation.
Time frame: 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.
Time frame: 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%).
Time frame: 2000 to 2017
Suspected origin of the toxin: food poisoning, dermal wound, intravenous drug use, intestinal colonisation by Clostridium sp. or unknown.
Time frame: 2000 to 2017
Whether the poisoning is isolated or one of multiple cases originating from the same source.
Time frame: 2000 to 2017
Botulinum toxin type if identified (A,B,C,D,E,F,G or H type toxin).
Time frame: 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%.
Time frame: 2000 to 2017
Whether the patient required or not mechanical ventilation during his ICU stay
Time frame: 2000 to 2017
Whether the patient required or not invasive mechanical ventilation during his ICU stay
Time frame: 2000 to 2017
Whether the patient required or not non invasive mechanical ventilation during his ICU stay
Time frame: 2000 to 2017
Whether the patient required a tracheotomy during his ICU stay
Time frame: 2000 to 2017
Whether the patient required or not enteral or parenteral nutritional support during his ICU stay
Time frame: 2000 to 2017
Number of days the patient required vasopressor support during his ICU stay
Time frame: 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.
Time frame: 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.
Time frame: 2000 to 2017
Whether botulinum antitoxin was administered.
Time frame: 2000 to 2017
Whether guanidine was administered as a treatment for the botulinum poisoning.
Time frame: 2000 to 2017
Number of hospitalisation days in the ICU.
Time frame: 2000 to 2017
Whether the patient acquired a healthcare related infection during his stay in the ICU.
Time frame: 2000 to 2017
Whether the patient had any mechanical ventilation related complications during his stay in the ICU.
Time frame: 2000 to 2017
Whether the patient acquired bedsores during his ICU stay.
Time frame: 2000 to 2017
Whether the patient acquired thrombo-embolic complications (deep vein thrombosis or pulmonary embolism) during his ICU stay.
Time frame: 2000 to 2017
Modified Rankin scale at ICU discharge, from 0 to 6, with 0 being asymptomatic and 6 being death.
Time frame: 2000 to 2017
Modified Rankin scale at hospital discharge, from 0 to 6, with 0 being asymptomatic and 6 being death.
Time frame: 2000 to 2017
Last known modified Rankin scale, from 0 to 6, with 0 being asymptomatic and 6 being death.
Time frame: 2000 to 2017
Proportion of patients alive at hospital discharge
Centre Hospitalier le Mans
Other
Retrospective Epidemiological Study on Patients Admitted for Botulism Poisoning in Intensive Care Units in France
Acronym: BotuREA
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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