Retrospective Epidemiological Study on Botulism in Intensive Care Units in France (BotuREA)

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

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.

Study Overview

• Status: Completed
• Conditions: Botulism; Poisoning

• Study Type: Observational
• Enrollment (Actual): 52

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 15 years and older (ADULT, OLDER_ADULT, CHILD)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

All patients 15 years of age or older with a clinical diagnosis of botulism.

Description

Inclusion Criteria:

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

Exclusion Criteria:

• None

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Survival	Proportion of patients alive at ICU discharge	2000 to 2017

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Age	Mean age of recruited patients	2000 to 2017
Weight	Mean weight of recruited patients	2000 to 2017
Height	Mean Height of recruited patients	2000 to 2017
History of motor impairment measured by the modified Rankin scale	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).	2000 to 2017
History of heart failure measured by the NYHA (New York Health Association) score	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).	2000 to 2017
History of chronic respiratory failure: use of daily oxygen therapy AND/OR non invasive ventilation	Chronic respiratory failure defined by the use of chronic oxygen therapy AND/OR daily non invasive ventilation.	2000 to 2017
History of chronic kidney disease measured by the glomerular filtration rate.	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.	2000 to 2017
History of cirrhosis as measured by the CHILD-PUGH score.	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%).	2000 to 2017
Source of the contamination	Suspected origin of the toxin: food poisoning, dermal wound, intravenous drug use, intestinal colonisation by Clostridium sp. or unknown.	2000 to 2017
Isolated or multiple cases	Whether the poisoning is isolated or one of multiple cases originating from the same source.	2000 to 2017
Botulinum Toxin type if identified	Botulinum toxin type if identified (A,B,C,D,E,F,G or H type toxin).	2000 to 2017
Severity at ICU admission	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%.	2000 to 2017
Mechanical ventilation requirement	Whether the patient required or not mechanical ventilation during his ICU stay	2000 to 2017
Invasive mechanical ventilation requirement	Whether the patient required or not invasive mechanical ventilation during his ICU stay	2000 to 2017
Non invasive mechanical ventilation requirement	Whether the patient required or not non invasive mechanical ventilation during his ICU stay	2000 to 2017
Whether or not the patient required a tracheotomy during his ICU stay.	Whether the patient required a tracheotomy during his ICU stay	2000 to 2017
Enteral or parenteral nutritional support	Whether the patient required or not enteral or parenteral nutritional support during his ICU stay	2000 to 2017
Number of days of vasopressor support	Number of days the patient required vasopressor support during his ICU stay	2000 to 2017
Acute kidney injury measured by maximum serum creatinine during ICU stay.	Whether the patient developped an acute kidney injury during his ICU stay: measured by maximum serum creatinine during ICU stay in µmol/L.	2000 to 2017
Severe liver failure	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.	2000 to 2017
Whether or not antitoxin was administered to the patient.	Whether botulinum antitoxin was administered.	2000 to 2017
Whether or not guanidine was administered during ICU stay	Whether guanidine was administered as a treatment for the botulinum poisoning.	2000 to 2017
Length of stay.	Number of hospitalisation days in the ICU.	2000 to 2017
Healthcare acquired infection	Whether the patient acquired a healthcare related infection during his stay in the ICU.	2000 to 2017
Mechanical ventilation related complications.	Whether the patient had any mechanical ventilation related complications during his stay in the ICU.	2000 to 2017
Bedrest complications: bedsores	Whether the patient acquired bedsores during his ICU stay.	2000 to 2017
Bedrest complications: thrombo-embolic complications	Whether the patient acquired thrombo-embolic complications (deep vein thrombosis or pulmonary embolism) during his ICU stay.	2000 to 2017
Disability at ICU discharge	Modified Rankin scale at ICU discharge, from 0 to 6, with 0 being asymptomatic and 6 being death.	2000 to 2017
Disability at hospital discharge	Modified Rankin scale at hospital discharge, from 0 to 6, with 0 being asymptomatic and 6 being death.	2000 to 2017
Last known disability	Last known modified Rankin scale, from 0 to 6, with 0 being asymptomatic and 6 being death.	2000 to 2017
Survival at hospital discharge	Proportion of patients alive at hospital discharge	2000 to 2017

Collaborators and Investigators

• Sponsor: Centre Hospitalier le Mans
• Investigators: Principal Investigator: Christophe Guitton, MD, Centre Hospitalier Le Mans

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 1, 2000
• Primary Completion (ACTUAL): December 31, 2017
• Study Completion (ACTUAL): August 15, 2018

Study Registration Dates

• First Submitted: August 31, 2018
• First Submitted That Met QC Criteria: September 5, 2018
• First Posted (ACTUAL): September 6, 2018

Study Record Updates

• Last Update Posted (ACTUAL): September 6, 2018
• Last Update Submitted That Met QC Criteria: September 5, 2018
• Last Verified: September 1, 2018

More Information

Terms related to this study

• Keywords: Intensive Care; Botulism
• Additional Relevant MeSH Terms: Chemically-Induced Disorders; Nervous System Diseases; Infections; Neuromuscular Diseases; Foodborne Diseases; Bacterial Infections; Bacterial Infections and Mycoses; Gram-Positive Bacterial Infections; Neuromuscular Junction Diseases; Clostridium Infections; Neurotoxicity Syndromes; Poisoning; Botulism
• Other Study ID Numbers: CHM-2017-538/05

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No