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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
60
Patients without evidence of tracheobronchial aspiration were randomized to immediate prophylactic Amoxicillin-Clavulanic acid 1,2 gr/8h
University Medical Centre Ljubljana
Ljubljana, Slovenia
Value of C-reactive protein (CRP) at day three
Expressed in milligram/litre (normal \<5 mg/L)
Time frame: Three days after admission to Intensive care unit (ICU)
Severity of systemic inflammatory response estimated by peak white blood cell count (WBC)
Expressed in number of white blood cells x 109 per litre (L)
Time frame: First measurement at admission in hospital and afterwards in 24 hours intervals during stay in the intensive care unite (ICU) but not longer then first seven days
Severity of systemic inflammatory response estimated by peak value of procalcitonin (PCT)
Expressed in microgram/litre (normal \<0.5 microgram/L)
Time frame: First measurement at admission in hospital and afterwards in 24 hours intervals during stay in the intensive care unite (ICU) but not longer then first seven days
Severity of systemic inflammatory response estimated by peak value of neutrophil Cluster of differentiation 64 (CD 64)
Neutrophil CD 64 expression was used as an index of sepsis with \>1.2 indicating greater likelihood of sepsis
Time frame: First measurement at admission in hospital and afterwards in 24 hours intervals in the first three days
Appearance of pneumonia on chest X ray
Time frame: Chest X ray was taken on admission and afterwards on daily basis during the stay in the intensive care unite but not longer than first week
Incidence of positive blind mini bronchoalveolar lavage (Mini-BAL) on day 3
Time frame: Mini-BAL was performed on the third day after the sudden cardiac arrest
Incidence of positive hemocultures
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Time frame: From the admission until the patient was transferred to the ward. This was always during the ICU stay-one month
Duration of tracheal intubation
Duration of intubation was expressed as days of intubation started with admission until the extubation. Because this is being done in intensive care unite, the time frame is duration of ICU stay
Time frame: From the day of admission until the extubation. This was always during the ICU stay- one month
Duration of mechanical ventilation
Duration of mechanical ventilation was expressed as days the patient needed the mechanical support for breathing regardless of mode of support
Time frame: From the admission until spontaneous breathing . This was during ICU stay-one month
ICU stay
Time frame: From the admission until the patient was transferred to ward, usually less than one month
Survival with good neurological outcome
Good neurological outcome was characterised using cerebral performance category (CPC) with 1-2 indicating good neurological recovery.
Time frame: Up to six months after the event