Title

Antibiotic Prophylaxis for Early Ventilator-associated Pneumonia in Neurological Patients
Antibiotic Prophylaxis for Early Ventilator-associated Pneumonia in Neurological Patients: A Randomized Trial
  • Phase

    Phase 4
  • Study Type

    Interventional
  • Status

    Withdrawn
  • Study Participants

    0
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.
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.
Study Started
Mar 31
2011
Primary Completion
Mar 31
2011
Study Completion
Mar 31
2011
Last Update
May 24
2016
Estimate

Drug Sultamicillin

Ampoules per 1.5 grams, three grams intravenously every 6 hours for 4 doses diluted in physiologic Sodium Chloride Solution

  • Other names: Sulbactam Ampicillin, Unasyn

Sultamicillin, Antibiotic Prophylaxis Experimental

Sultamicillin, Antibiotic Prophylaxis

Placebo Placebo Comparator

Physiologic Sodium Chloride Solution

Criteria

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.
No Results Posted