Effect of early antibiotics on patients with out-of-hospital cardiac arrest

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

This study is testing if not giving antibiotics to adults who have had a cardiac arrest outside the hospital is just as safe and effective as giving them early antibiotic treatment.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 1000 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Hamad Medical Corporation (Industry-sponsored)
• Drugs / interventions: prednisone
• Locations: 1 site (Doha, Baladiyat ad Dawhah)
• Trial ID: NCT05914779 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to evaluate whether not administering antibiotics to out-of-hospital cardiac arrest (OHCA) patients with a very low likelihood of infection is as effective as providing early antibiotic treatment. It will compare 28-day all-cause mortality rates, incidence of proven infections, and lengths of ICU and overall hospital stays between the two groups. The study will involve adults over 18 years old who present to the emergency department after OHCA. Participants will be randomly assigned to receive either no antibiotics or early antibiotic therapy.

Who should consider this trial

Good fit: Ideal candidates are adults over 18 years old who have experienced out-of-hospital cardiac arrest and have a very low likelihood of infection.

Not a fit: Patients with clear evidence of infection or those who have received antibiotics within the past week will not benefit from this study.

Why it matters

Potential benefit: If successful, this study could help refine treatment protocols for OHCA patients, potentially reducing unnecessary antibiotic use.

How similar studies have performed: Other studies have explored antibiotic use in similar contexts, but this specific approach is relatively novel.

Eligibility criteria

Inclusion Criteria:

* ● 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.

Exclusion Criteria:

* 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.
  * Known immunocompromised states (including HIV/AIDS, transplant recipients on immunosuppressant drugs, long-term \[\> 3 weeks of prednisone \>5mg/day equivalent\] steroid therapy).
  * Patients on immunologic disease modifying agents (commonly known as "biologics")
  * Patients considered "brain-dead" or "vegetative state"
  * Patients transferred from another hospital, long term care facility or institution
  * Neutropenia (total WBC \<1,500/mm3 or absolute neutrophil count of \<1,000/mm3)

Where this trial is running

Doha, Baladiyat ad Dawhah

• Hamad Medical Corporation — Doha, Baladiyat ad Dawhah, Qatar (Recruiting)

Study contacts

• Principal investigator: Adeel A Butt, MBBS, MS — Hamad Medical Corporation
• Study coordinator: Adeel A Butt, MBBS, MS

Conditions Infection, Bacterial; Out-Of-Hospital Cardiac Arrest