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

NCT ID: NCT02899507

Last Updated: 2016-09-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-09-30
• Study Completion Date: 2015-04-30

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.

Conditions

Out-of-hospital Cardiac Arrest

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Prophylactic antibiotic

Amoxicillin-Clavulanic acid 1.2g every 8h

Group Type: EXPERIMENTAL

Amoxicillin-Clavulanic acid

Intervention Type: DRUG

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

Clinically-driven antibiotics

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Amoxicillin-Clavulanic acid

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

Intervention Type: DRUG

Other Intervention Names

Amoksiklav, Augmentin

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Medical Centre Ljubljana

OTHER

Sponsor Role: lead

Responsible Party

Marko Noc

MD, PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Marko Noč, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University Medical Centre Ljubljana

Locations

University Medical Centre Ljubljana

Ljubljana, , Slovenia

Countries

Slovenia

References

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Reference Type: BACKGROUND

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Reference Type: BACKGROUND

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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.

Reference Type: DERIVED

PMID: 27987397 (View on PubMed)

Other Identifiers

P3-0331

Identifier Type: -

Identifier Source: org_study_id