Clinical trial NCT02899507: Prophylactic Antibiotics in Comatose Survivors of Out-of-hospital Cardiac Arrest
Official title: Prophylactic Versus Clinically-driven Antibiotics in Comatose Survivors of Out-of-hospital Cardiac Arrest
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Out-of-hospital Cardiac Arrest
Keywords: Out-of-hospital cardiac arrest
Prophylactic antibiotics
Lead sponsor: University Medical Centre Ljubljana
Sponsor class: OTHER
First posted: 2016-09-14
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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.

Eligibility criteria: 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

Primary outcomes:
measure: Value of C-reactive protein (CRP) at day three
timeFrame: Three days after admission to Intensive care unit (ICU)
Secondary outcomes:
measure: Severity of systemic inflammatory response estimated by peak white blood cell count (WBC)
timeFrame: 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
measure: Severity of systemic inflammatory response estimated by peak value of procalcitonin (PCT)
timeFrame: 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
measure: Severity of systemic inflammatory response estimated by peak value of neutrophil Cluster of differentiation 64 (CD 64)
timeFrame: First measurement at admission in hospital and afterwards in 24 hours intervals in the first three days
measure: Appearance of pneumonia on chest X ray
timeFrame: 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
measure: Incidence of positive blind mini bronchoalveolar lavage (Mini-BAL) on day 3
timeFrame: Mini-BAL was performed on the third day after the sudden cardiac arrest
measure: Incidence of positive hemocultures
timeFrame: From the admission until the patient was transferred to the ward. This was always during the ICU stay-one month
measure: Duration of tracheal intubation
timeFrame: From the day of admission until the extubation. This was always during the ICU stay- one month
measure: Duration of mechanical ventilation
timeFrame: From the admission until spontaneous breathing . This was during ICU stay-one month
measure: ICU stay
timeFrame: From the admission until the patient was transferred to ward, usually less than one month
measure: Survival with good neurological outcome
timeFrame: Up to six months after the event
Other outcomes:
Locations:
city: Ljubljana
country: Slovenia
facility: University Medical Centre Ljubljana
Study officials:
affiliation: University Medical Centre Ljubljana
name: Marko Noč, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Woo JH, Lim YS, Yang HJ, Park WB, Cho JS, Kim JJ, Hyun SY, Lee G. Factors associated with pneumonia in post-cardiac arrest patients receiving therapeutic hypothermia. Am J Emerg Med. 2014 Feb;32(2):150-5. doi: 10.1016/j.ajem.2013.10.035. Epub 2013 Oct 26.
citation: Ribaric SF, Turel M, Knafelj R, Gorjup V, Stanic R, Gradisek P, Cerovic O, Mirkovic T, Noc M. Prophylactic versus clinically-driven antibiotics in comatose survivors of out-of-hospital cardiac arrest-A randomized pilot study. Resuscitation. 2017 Feb;111:103-109. doi: 10.1016/j.resuscitation.2016.11.025. Epub 2016 Dec 14.