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Completed

NCT Number: NCT02899507

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

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.

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Key information

Conditions

Out-Of-Hospital Cardiac Arrest Cardiovascular Diseases Heart Arrest Heart Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

University Medical Centre Ljubljana

Ljubljana, 1000, Slovenia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Amoxicillin-clavulanic acid

Drug

Patients without evidence of tracheobronchial aspiration were randomized to immediate prophylactic Amoxicillin-Clavulanic acid 1,2 gr/8h

Other names: Amoksiklav, Augmentin

Primary outcomes

  1. 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)

Secondary outcomes

  1. 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)

  2. 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)

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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

  9. ICU stay

    Time frame: From the admission until the patient was transferred to ward, usually less than one month

  10. 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.

Sponsors and collaborators

Lead sponsor

University Medical Centre Ljubljana

Other

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Sep 14, 2016
Registry last updated
Sep 14, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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