Clinical Trial: Prophylactic Antibiotics in Comatose Survivors of Out-of-hospital Cardiac Arrest

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Prophylactic Versus Clinically-driven Antibiotics in Comatose Survivors of Out-of-hospital Cardiac Arrest

Brief Summary: 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.

Detailed Summary: 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.
Sponsor: University Medical Centre Ljubljana

Current Primary Outcome: Value of C-reactive protein (CRP) at day three [ Time Frame: Three days after admission to Intensive care unit (ICU) ]

Expressed in milligram/litre (normal <5 mg/L)


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Severity of systemic inflammatory response estimated by peak white blood cell count (WBC) [ 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 ]
    Expressed in number of white blood cells x 109 per litre (L)
  • Severity of systemic inflammatory response estimated by peak value of procalcitonin (PCT) [ 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 ]
    Expressed in microgram/litre (normal <0.5 microgram/L)
  • Severity of systemic inflammatory response estimated by peak value of neutrophil Cluster of differentiation 64 (CD 64) [ Time Frame: First measurement at admission in hospital and afterwards in 24 hours intervals in the first three days ]
    Neutrophil CD 64 expression was used as an index of sepsis with >1.2 indicating greater likelihood of sepsis
  • 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 [ 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 [ Time Frame: From the day of admission until the extubation. This was always during the ICU stay- one month ]
    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
  • Duration of mechanical ventilation [ Time Frame: From the admission until spontaneous breathing . This was during ICU stay-one month ]
    Duration of mechanical ventilation was expressed as days the patient needed the mechanical support for breathing regardless of mode of support
  • ICU stay [ Time Frame: From the admission until the patient was transferred to ward, usually less than one month ]
  • Survival with good neurological outcome [ Time Frame: Up to six months after the event ]
    Good neurological outcome was characterised using cerebral performance category (CPC) with 1-2 indicating good neurological recovery.


Original Secondary Outcome: Same as current

Information By: University Medical Centre Ljubljana

Dates:
Date Received: June 30, 2016
Date Started: September 2013
Date Completion:
Last Updated: September 8, 2016
Last Verified: August 2016