Skip to main content
OpenTrials
Completed

NCT Number: NCT03658902

Retrospective Epidemiological Study on Botulism 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.

Completed

Looking for future studies?

Notify Me

Key information

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • None

Treatment and study plan

Primary outcomes

  1. Survival

    Time frame: 2000 to 2017

    Proportion of patients alive at ICU discharge

Secondary outcomes

  1. Age

    Time frame: 2000 to 2017

    Mean age of recruited patients

  2. Weight

    Time frame: 2000 to 2017

    Mean weight of recruited patients

  3. Height

    Time frame: 2000 to 2017

    Mean Height of recruited patients

  4. History of motor impairment measured by the modified Rankin scale

    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).

  5. History of heart failure measured by the NYHA (New York Health Association) score

    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).

  6. History of chronic respiratory failure: use of daily oxygen therapy AND/OR non invasive ventilation

    Time frame: 2000 to 2017

    Chronic respiratory failure defined by the use of chronic oxygen therapy AND/OR daily non invasive ventilation.

  7. History of chronic kidney disease measured by the glomerular filtration rate.

    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.

  8. History of cirrhosis as measured by the CHILD-PUGH score.

    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%).

  9. Source of the contamination

    Time frame: 2000 to 2017

    Suspected origin of the toxin: food poisoning, dermal wound, intravenous drug use, intestinal colonisation by Clostridium sp. or unknown.

  10. Isolated or multiple cases

    Time frame: 2000 to 2017

    Whether the poisoning is isolated or one of multiple cases originating from the same source.

  11. Botulinum Toxin type if identified

    Time frame: 2000 to 2017

    Botulinum toxin type if identified (A,B,C,D,E,F,G or H type toxin).

  12. Severity at ICU admission

    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%.

  13. Mechanical ventilation requirement

    Time frame: 2000 to 2017

    Whether the patient required or not mechanical ventilation during his ICU stay

  14. Invasive mechanical ventilation requirement

    Time frame: 2000 to 2017

    Whether the patient required or not invasive mechanical ventilation during his ICU stay

  15. Non invasive mechanical ventilation requirement

    Time frame: 2000 to 2017

    Whether the patient required or not non invasive mechanical ventilation during his ICU stay

  16. Whether or not the patient required a tracheotomy during his ICU stay.

    Time frame: 2000 to 2017

    Whether the patient required a tracheotomy during his ICU stay

  17. Enteral or parenteral nutritional support

    Time frame: 2000 to 2017

    Whether the patient required or not enteral or parenteral nutritional support during his ICU stay

  18. Number of days of vasopressor support

    Time frame: 2000 to 2017

    Number of days the patient required vasopressor support during his ICU stay

  19. Acute kidney injury measured by maximum serum creatinine during 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.

  20. Severe liver failure

    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.

  21. Whether or not antitoxin was administered to the patient.

    Time frame: 2000 to 2017

    Whether botulinum antitoxin was administered.

  22. Whether or not guanidine was administered during ICU stay

    Time frame: 2000 to 2017

    Whether guanidine was administered as a treatment for the botulinum poisoning.

  23. Length of stay.

    Time frame: 2000 to 2017

    Number of hospitalisation days in the ICU.

  24. Healthcare acquired infection

    Time frame: 2000 to 2017

    Whether the patient acquired a healthcare related infection during his stay in the ICU.

  25. Mechanical ventilation related complications.

    Time frame: 2000 to 2017

    Whether the patient had any mechanical ventilation related complications during his stay in the ICU.

  26. Bedrest complications: bedsores

    Time frame: 2000 to 2017

    Whether the patient acquired bedsores during his ICU stay.

  27. Bedrest complications: thrombo-embolic complications

    Time frame: 2000 to 2017

    Whether the patient acquired thrombo-embolic complications (deep vein thrombosis or pulmonary embolism) during his ICU stay.

  28. Disability at ICU discharge

    Time frame: 2000 to 2017

    Modified Rankin scale at ICU discharge, from 0 to 6, with 0 being asymptomatic and 6 being death.

  29. Disability at hospital discharge

    Time frame: 2000 to 2017

    Modified Rankin scale at hospital discharge, from 0 to 6, with 0 being asymptomatic and 6 being death.

  30. Last known disability

    Time frame: 2000 to 2017

    Last known modified Rankin scale, from 0 to 6, with 0 being asymptomatic and 6 being death.

  31. Survival at hospital discharge

    Time frame: 2000 to 2017

    Proportion of patients alive at hospital discharge

Sponsors and collaborators

Lead sponsor

Centre Hospitalier le Mans

Other

Registry information

Official study title

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

Acronym: BotuREA

Important dates

Study start
2000
Primary completion
2017
Study completion
2018
First posted
Sep 6, 2018
Registry last updated
Jul 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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.

Published trials that share one or more normalized conditions with this study.