Ventilator Associated Pneumonia
Conditions
Keywords
Ventilator associated pneumonia, Coma, Brain Injuries, Intensive care units, antibiotic prophylaxis
Brief summary
This study seeks to assess whether coma patients really benefit from the use of antibiotics as a prophylactic for reducing the incidence of early ventilator-associated pneumonia in this population group. For this we consider the use of ampicillin sulbactam antibiotic which has a low ability to induce resistance, efficacy and safety observed during the time that has been used, even in patients with neurosurgical pathology, and to be broadly available in our environment. Our hypothesis is that neurological patients in coma state, requiring mechanical ventilation, the application of antibiotic prophylaxis compared with placebo reduces the incidence of early ventilator-associated pneumonia.
Detailed description
Ventilator-associated pneumonia (VAP) is one of the most common nosocomial infections occur in intensive care units, with frequencies ranging between 15% and 45%, which determine an attributable mortality of 25% to 27% Patients with compromised state of consciousness brought to mechanical ventilation, have a much higher reported incidence that patients without neurological involvement, reaches between 44 and 70%. These data have led to plan the implementation of strategies to reduce the incidence of early pneumonia in this population group, to thereby favorably influence the high rates of mortality, morbidity and costs that arise. Then we design this study to assess whether these patients really benefit from the use of antibiotics as a prophylactic, considering also the high impact that this would have given the high incidence of early ventilator-associated pneumonia in this population group.
Interventions
DRUGSultamicillin
Ampoules per 1.5 grams, three grams intravenously every 6 hours for 4 doses diluted in physiologic Sodium Chloride Solution
Sponsors
Hospital Pablo Tobón Uribe
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* All patients admitted to intensive care units,with score in the Glasgow Coma scale less than nine. * Requiring mechanical ventilation for more than 48 hours * Includes all patients with structural or metabolic coma
Exclusion criteria
* Pregnant women * History of allergic reactions to ampicillin sulbactam * Patients admitted as potential organ donors * Patients with an indication of antibiotic therapy, or who have received more than 2 doses of any antibiotic previously. * Hospital stay for more than 48 hours before intubation.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Impact of prophylaxis with ampicillin sulbactam versus placebo on the incidence of early ventilator-associated pneumonia | 2 years | To determine the impact of prophylaxis with ampicillin sulbactam versus placebo on the incidence of early ventilator-associated pneumonia in patients with altered level of consciousness with a score on the Glasgow Coma Scale less than or equal to 8 and requiring mechanical ventilation for more than 48 hours |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Effect of antibiotic prophylaxis versus placebo on the incidence of other infections | 2 years | Compare the effect of antibiotic prophylaxis versus placebo on the incidence of later ventilator-associated pneumonia, as well as in other non-pulmonary infections (catheter sepsis, bacteremia, meningitis, urinary tract infection). |
Countries
Colombia
Outcome results
None listed