Condition category
Circulatory System
Date applied
18/01/2017
Date assigned
22/02/2017
Last edited
30/08/2017
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
A cardiac arrest is a serious medical condition in which the heart suddenly stops beating and is a major cause of death in people across all age groups. An out-of-hospital cardiac arrest (OHCA) is where this happens when a person is not in hospital, and is the most common type of cardiac arrest. OHCA patients have low rates of survival to hospital discharge, between 7.9-21.0% in various regions in North America, with a higher likelihood of survival in those with ventricular fibrillation (a heart rhythm abnormality). Targeted temperature management (TTM) is a treatment which works to achieve a specific body temperature for a specific period of time. It has been found to improve neurological (brain and nervous system) outcomes and reduce death rates, and is widely adopted in international guidelines. Although TTM has been found to improve long-term outcomes, recent studies report that it could be related to the development of infections. The aim of this study is to find out whether giving patients antibiotics before they have TTM can reduce rates of infections, time of breathing machines, the length of stay in the intensive care unit and hospital as a whole and death rates.

Who can participate?
Adults who have had an out of hospital cardiac arrest who are suitable for treatment with TTM.

What does the study involve?
All participants receive standard care for out of hospital cardiac arrest management while they are in hospital, including heart monitoring, help with breathing using a breathing machine and TTM. Participants are randomly allocated to one of two groups. Those in the first group take antibiotics for three days, and those in the second group take a placebo (dummy drug) for three days. Participants in both groups are monitored until they are discharged from hospital and have their medical notes regularly reviewed in order to monitor infections, survival and length of time in hospital.

What are the possible benefits and risks of participating?
Participants may benefit from an improved outcome after their cardiac arrest. There is a small risk of diarrhea from the antibiotics used in this study.

Where is the study run from?
University Health Network (Canada)

When is the study starting and how long is it expected to run for?
February 2016 to December 2021

Who is funding the study?
University Health Network (Canada)

Who is the main contact?
Dr Christopher Overgaard
Chris.Overgaard@uhn.ca

Trial website

Contact information

Type

Scientific

Primary contact

Dr Christopher Overgaard

ORCID ID

Contact details

UHN - Toronto General Hospital
6EN Room 232
200 Elizabeth Street
Toronto ON
M5G 2C4
Canada
+1 416 340-4800 Ext. 6265
Chris.Overgaard@uhn.ca

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

2017-001

Study information

Scientific title

A randomized controlled study to evaluate the effect of prophylactic antibiotics in the prevention of early CCU complications in post-cardiac arrest survivors receiving targeted temperature management

Acronym

Study hypothesis

The aim of this study is to determine if prophylactic antibiotics is associated with a reduction in early post-hospitalization adverse outcomes, in duration of mechanical ventilation, as well as ICU and hospital LOS.

Ethics approval

University Health Network Research Ethics Board, 10/05/2017, ref: 16-5632-B

Study design

Single-centre randomized controlled trial

Primary study design

Interventional

Secondary study design

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Out of hospital cardiac arrest

Intervention

Participants are randomized 1:1 to one of two groups.

Intervention group: Participants receive 3 doses of Ceftriazone every 24 hours. The first dose will be at time of randomization.

Control group: Participants receive 3 doses of placebo (D5W without antibiotics) every 24 hours. The first dose will be at time of randomization.

Intervention type

Drug

Phase

Not Applicable

Drug names

Ceftriaxone

Primary outcome measures

1. Incidence of VAP/HAP (within 7 days) is measured using review of patient notes at time of enrollment to 7 days post randomization
2. Incidence of sepsis (within 7 days) is measured using review of patient notes at time of enrollment to 7 days post randomization
3. In-hospital mortality (all cause) is measured using review of patient notes at time of enrollment to day of discharge from hospital

Secondary outcome measures

1. CCU LOS (hours) is measured by reviewing patient notes at the time of admission up to time of discharge from CCU
2. Hospital LOS (days) is measured by reviewing patient notes at time of admission up to time of discharge from hospital
3. Neurologic outcome at time of discharge is measured by categorising patients by cerebral performance category, CPC 1-2 or 3-5 at the time of discharge from hospital
4. Complications of antibiotic use (C. difficile, thrush, other nosocomial infection) is measured by reviewing patient notes during their hospital stay
5. Necessity for re-intubation is measured by reviewing patient notes at the time of admission up to discharge from hospitalization

Overall trial start date

01/02/2016

Overall trial end date

31/12/2020

Reason abandoned

Eligibility

Participant inclusion criteria

1. Age >18 years
2. Out-of-hospital cardiac arrest with ROSC
3. Glasgow coma scale <8 at time of hospital admission
4. Treated with TTM 32-34 degrees Celsius
5. Delay from ROSC to randomization <6 hours
6. Consent from substitute decision maker (SDM)

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

50

Participant exclusion criteria

1. In hospital cardiac arrest
2. Ongoing antibiotic use for other infection prior to hospitalization (up to 1 week prior)
3. Diagnosis of pneumonia or sepsis prior to hospitalization
4. Non-cardiac illness that is immediate threat to life (i.e. intracranial hemorrhage, perforated viscus etc.).
5. Pregnancy
6. Known anaphylactic reaction to antibiotic used in study

Recruitment start date

01/03/2017

Recruitment end date

01/03/2020

Locations

Countries of recruitment

Canada

Trial participating centre

University Health Network
200 Elizabeth St.
Toronto, ON
M5G 2C4
Canada

Sponsor information

Organisation

University Health Network

Sponsor details

200 Elizabeth Street
Toronto
M5G 2C4
Canada

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Hospital/treatment centre

Funder name

University Health Network

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Results will be presented at the Cardiology audit meeting and submitted for publication once completed.

IPD Sharing plan:
The datasets generated during and/or analysed during the current study are/will be available upon request from Dr. Chris Overgaard (Chris.Overgaard@uhn.ca)

Intention to publish date

31/12/2021

Participant level data

Available on request

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

30/08/2017: Ethics approval has been added.