Botulism; Poisoning Clinical Trial
— BotuREAOfficial title:
Retrospective Epidemiological Study on Patients Admitted for Botulism Poisoning in Intensive Care Units in France
| Verified date | September 2018 |
| Source | Centre Hospitalier le Mans |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
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.
| Status | Completed |
| Enrollment | 52 |
| Est. completion date | August 15, 2018 |
| Est. primary completion date | December 31, 2017 |
| Accepts healthy volunteers | |
| Gender | All |
| Age group | 15 Years and older |
| Eligibility |
Inclusion Criteria: - Clinical diagnosis of botulism - Admission in an intensive care or high dependancy unit Exclusion Criteria: |
| Country | Name | City | State |
|---|---|---|---|
| n/a | |||
| Lead Sponsor | Collaborator |
|---|---|
| Centre Hospitalier le Mans |
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Survival | Proportion of patients alive at ICU discharge | 2000 to 2017 | |
| Secondary | Age | Mean age of recruited patients | 2000 to 2017 | |
| Secondary | Weight | Mean weight of recruited patients | 2000 to 2017 | |
| Secondary | Height | Mean Height of recruited patients | 2000 to 2017 | |
| Secondary | 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 | |
| Secondary | 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 | |
| Secondary | 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 | |
| Secondary | 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 | |
| Secondary | 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 | |
| Secondary | 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 | |
| Secondary | Isolated or multiple cases | Whether the poisoning is isolated or one of multiple cases originating from the same source. | 2000 to 2017 | |
| Secondary | Botulinum Toxin type if identified | Botulinum toxin type if identified (A,B,C,D,E,F,G or H type toxin). | 2000 to 2017 | |
| Secondary | 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 | |
| Secondary | Mechanical ventilation requirement | Whether the patient required or not mechanical ventilation during his ICU stay | 2000 to 2017 | |
| Secondary | Invasive mechanical ventilation requirement | Whether the patient required or not invasive mechanical ventilation during his ICU stay | 2000 to 2017 | |
| Secondary | Non invasive mechanical ventilation requirement | Whether the patient required or not non invasive mechanical ventilation during his ICU stay | 2000 to 2017 | |
| Secondary | 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 | |
| Secondary | Enteral or parenteral nutritional support | Whether the patient required or not enteral or parenteral nutritional support during his ICU stay | 2000 to 2017 | |
| Secondary | Number of days of vasopressor support | Number of days the patient required vasopressor support during his ICU stay | 2000 to 2017 | |
| Secondary | 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 | |
| Secondary | 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 | |
| Secondary | Whether or not antitoxin was administered to the patient. | Whether botulinum antitoxin was administered. | 2000 to 2017 | |
| Secondary | Whether or not guanidine was administered during ICU stay | Whether guanidine was administered as a treatment for the botulinum poisoning. | 2000 to 2017 | |
| Secondary | Length of stay. | Number of hospitalisation days in the ICU. | 2000 to 2017 | |
| Secondary | Healthcare acquired infection | Whether the patient acquired a healthcare related infection during his stay in the ICU. | 2000 to 2017 | |
| Secondary | Mechanical ventilation related complications. | Whether the patient had any mechanical ventilation related complications during his stay in the ICU. | 2000 to 2017 | |
| Secondary | Bedrest complications: bedsores | Whether the patient acquired bedsores during his ICU stay. | 2000 to 2017 | |
| Secondary | 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 | |
| Secondary | 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 | |
| Secondary | 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 | |
| Secondary | Last known disability | Last known modified Rankin scale, from 0 to 6, with 0 being asymptomatic and 6 being death. | 2000 to 2017 | |
| Secondary | Survival at hospital discharge | Proportion of patients alive at hospital discharge | 2000 to 2017 |