Prophylactic Antibiotics in Comatose Survivors of Out-of-hospital Cardiac Arrest

University Medical Centre Ljubljana

Status and phase: Completed; Phase 4

Conditions: Out-of-hospital Cardiac Arrest

Treatments: Drug: Amoxicillin-Clavulanic acid

Study type: Interventional

Funder types: Other

Identifiers

NCT02899507

P3-0331

Details and patient eligibility

About

The purpose of this study is to determine whether there is potential benefits of prophylactic antibiotic treatment in comatose survivors of out-of-hospital cardiac arrest (OHCA) treated in intensive care unit with therapeutic hypothermia.

Full description

Postresuscitation management of comatose survivors of out-of-hospital cardiac arrest (OHCA) significantly improved and "bundle of care" including therapeutic hypothermia, immediate coronary angiography, percutaneous coronary intervention (PCI) and contemporary intensive care nowadays leads to survival with good neurological recovery. Benefit of prophylactic antibiotics, which may suppress development of postresuscitation infection and especially early onset pneumonia and thereby decrease the severity of postresuscitation systemic inflammatory response, is controversial. Because of these uncertainties, the investigators performed a single-center randomized clinical trial comparing prophylactic versus clinically-driven administration of antibiotics in comatose survivors of OHCA. The investigators hypothesized that prophylactic antibiotics may decrease the severity of postresuscitation systemic inflammatory response by reducing the incidence of postresuscitation infection and especially pneumonia which was further addressed by repeat microbiological sampling.

Enrollment: 60 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Female and male over 18 years old
• Comatose survivors of out-of-hospital cardiac arrest treated in intensive care unit with therapeutic hypothermia

Exclusion criteria

• Suspected or confirmed pregnancy
• Allergy to amoxicillin-clavulanic acid
• Tracheobronchial aspiration
• Antibiotic therapy before cardiac arrest
• Need of antibiotics due to other causes
• Candidates for immediate veno-arterial extracorporeal membrane oxygenation (VA ECMO)
• Patients in whom no active treatment was decided on admission

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

Prophylactic antibiotic

Experimental group

Description:

Amoxicillin-Clavulanic acid 1.2g every 8h

Treatment:

Drug: Amoxicillin-Clavulanic acid

Clinically-driven antibiotics

No Intervention group

Description:

Administration of antibiotics in clinically-driven group was at the discretion of attending intensivist. Selection of antibiotic in clinically-driven group was empirical or based on the results of bacterial cultures if already available.