Trials / Completed
CompletedNCT02186951
Antibiotherapy During Therapeutic Hypothermia to Prevent Infectious Complications
Prevention of Early Ventilator-associated Pneumonia With Antibiotic Therapy in Patients Treated With Mild Therapeutic Hypothermia After Cardiac Arrest.
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 197 (actual)
- Sponsor
- University Hospital, Limoges · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
Mild therapeutic hypothermia is currently recommended in management of cardiac arrests with shockable rhythm. In mechanically ventilated patients who were resuscitated after out-of-hospital cardiac arrests, mild therapeutic hypothermia side effects are conductive for infectious complications and especially for ventilator-associated pneumonia (VAP). Despite high incidence of VAP and other infectious complications, it is not currently recommended to use antibiotic prophylaxis on the responsible germs. Yet VAP incidence could be decreased if an antibiotic therapy was systematically given to patient treated with mild therapeutic hypothermia after a cardiac arrest. Several retrospective studies showed less infectious complications but also decreased morbidity and mortality related to these complications when antibiotic therapy was given early to patients treated with therapeutic hypothermia after cardiac arrest.
Detailed description
Multicenter add-on randomized controlled double-blind trial assessing the efficacy of preventive antibiotics amoxicillin-clavulanic acid vs placebo to prevent occurrence of early VAP after out-of-hospital cardiac arrest receiving mild therapeutic hypothermia, in addition to usual VAP prevention measures.
Conditions
- Ventilator-associated Pneumonia
- Cardiac Arrests With Shockable Rhythm
- Mild Therapeutic Hypothermia
- Preventive Antibiotics
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Amoxicillin - clavulanic acid | Amoxicillin-clavulanic acid 1g, three times a day during 2 days, started within one hour after randomization and before the beginning of hypothermia. |
| DRUG | Placebo | Placebo 1g, three times a day during 2 days, started within one hour after randomization and before the beginning of hypothermia. |
Timeline
- Start date
- 2014-08-18
- Primary completion
- 2016-10-27
- Completion
- 2017-09-14
- First posted
- 2014-07-10
- Last updated
- 2020-03-18
Locations
16 sites across 1 country: France
Source: ClinicalTrials.gov record NCT02186951. Inclusion in this directory is not an endorsement.