Antibiotherapy During Therapeutic Hypothermia to Prevent Infectious Complications

• Status: Completed
• Trial end date: 2017-09-14
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Hospital, Limoges
• Treatments: Amoxicillin; Amoxicillin-Potassium Clavulanate Combination; Clavulanic Acid; Clavulanic Acids

Criteria

Inclusion Criteria:

• Older than 18 years-old, intubated and mechanically ventilated after out-of-hospital resuscitated cardiac arrest secondary to shockable rhythm

• Hospitalized in an ICU

• Mild therapeutic hypothermia procedure (32° to 35°C) scheduled (24 to 36 hours)

• Delay from ROSC to randomisation < 6 hours

• Consent from family members or emergency consent

Exclusion Criteria:

• Pregnancy

• Out-of-hospital cardiac arrest secondary to non shockable rhythm and In-hospital cardiac arrest

• Need for cardiac support by cardiopulmonary bypass

• Ongoing antibiotic therapy or during the week before

• Ongoing or concomitant pneumonia

• Known chronic colonization with MRB

• Hypersensitivity to the active substances, to any of the penicillins or to any of the excipients.

• History of a severe immediate hypersensitivity reaction (e.g. anaphylaxis) to another beta-lactam agent (e.g. a cephalosporin, carbapenem or monobactam).

• History of jaundice/hepatic impairment due to amoxicillin/clavulanic acid, according to the latest version of the SmPC.

• Previous lung disease

• Predictable decision of early care limitation

• Patient under guardianship or curatorship

• Moribund patient

• Participation to another trial within 30 days