Finding studies
Finding studies
Take this into the appointment.
Saves the questions and what to expect into your notes, next to the visit they belong to.
Sergio I Valdés-Ferrer, MD, PhD
CONTACT
Juan Sierra-Madero, MD
CONTACT
Lead
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
The study will be divided into two phases, each with different variables to evaluate, as described below: The primary objective of the first phase (proof-of-concept) will be to evaluate the effect of pyridostigmine on the serum level of interleukin (IL)-6 as an indicator of severe inflammation, as well as its kinetics throughout the days that the patient is hospitalized. In the first phase, we will evaluate the safety and feasibility of the study in a representative sample and we will explore in a preliminary way the magnitude of the effect of the intervention. Safety will be evaluated according to the adverse effects reported in patients with acute intoxication (accidental or in suicide attempt) with pyridostigmine: 1. Abdominal pain/cramps 2. Diarrhea 3. Vomiting, nausea, or both 4. Hypersalivation 5. Urinary incontinence 6. Fasciculations or muscle weakness 7. Blurred vision In the second phase (to be carried out only if the results of the first phase justify it), the primary outcome to be evaluated is mortality, the requirement of invasive or non-invasive mechanical ventilation, or an increase in the SOFA scale ≥2 points. The following secondary outcomes were evaluated: changes in the total SOFA score between study entry and evaluation at 3, 7, and 14 days; the number of days of hospital stay, days of hospitalization in the intensive care unit, and the need (and if applicable, the number of days required) for invasive or non-invasive mechanical ventilation. The variables to measure are sex, age at hospitalization, date of COVID-19 diagnosis, date and SOFA scale measurement, date of hospitalization, date of transfer to the intensive care unit, date of initiation of mechanical ventilation. , date and reason for leaving the intensive care unit.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
