Impact of Early Antibiotics on Non-Traumatic Out of Hospital Cardiac Arrest (OHCA)

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• ● 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.

Locations
Other Locations
Qatar
Hamad Medical Corporation
RECRUITING
Doha
Contact Information
Primary
Adeel A Butt, MBBS, MS
aabutt@hamad.qa
+97433311228
Time Frame
Start Date: 2023-03-01
Estimated Completion Date: 2025-12-31
Participants
Target number of participants: 1000
Treatments
Experimental: Subject with antibiotics treatment
Individuals with low risk of infection after OHCA will be randomized to either 1) early antibiotics, or 2) no antibiotics.~Experimental arm received antibiotics as per local hospital clinical care pathways and physician choice.
Active_comparator: Subjects with no antibiotics treatment
Individuals with low risk of infection after OHCA will be randomized to either 1) early antibiotics, or 2) no antibiotics.~Active comparator arm will receive no antibiotics,
Related Therapeutic Areas
Sponsors
Leads: Hamad Medical Corporation

This content was sourced from clinicaltrials.gov