Impact of Early Antibiotics on Non-Traumatic Out of Hospital Cardiac Arrest (OHCA)
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorHamad Medical Corporation
About this trial
Specific Aim : The specific aim is to conduct a randomized prospective clinical trial to determine whether no antibiotics in OHCA patients in the ED with very low likelihood of infection is non-inferior to early antibiotic treatment. Hypothesis a: 28-day all-cause mortality will be non-inferior in OHCA patients with very low likelihood of infection who do not receive antibiotic therapy compared with those who receive early antibiotic therapy Hypothesis b: There will be no difference in subsequent incidence of proven infections in the no antibiotics vs, early antibiotics groups Hypothesis c: There will be no difference in the length of ICU stay and overall hospital stay in the early antibiotics vs. no antibiotics groups
Eligibility criteria
Qualifiers
● Adults aged >18 years, presenting to HGH ED after out-of-hospital cardiac arrest
Patients with low likelihood of infection as per the definitions provided above
Ability to obtain informed consent from the subjects or their next of kin/family member/legal surrogate in case of incapacitation due to sedation, mechanical ventilation, etc. In case the next of kin is not available, an independent physician who is not a part of the investigative team will complete and sign the checklist as per HMC Policy "RES 11026_Appendix 6.5". (see section 4.1.3 for details) A member of the investigative team and a witness will also sign this form before the potential subject is enrolled in the study.
Disqualifiers
Patients who have clear evidence of infection, as defined by criteria for the study.
Patients who have received antibiotics within the last 1 week prior to admission.
Patients with malignancy, except those who have been cured or in complete remission.
Females with known pregnancy.
Trial design
Treatments tested in this trial
- No use of antibiotics
- with antibiotics treatment
Treatment groups
1,000 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov