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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
As above
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Subject with antibiotics treatment | Experimental | 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. |
|
| Subjects with no antibiotics treatment | Active Comparator | 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, |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| No use of antibiotics | Other | Subjects will be randomized into antibiotics and no antibiotics groups based on inclusion and exclusion criteria |
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| Measure | Description | Time Frame |
|---|---|---|
| 28-day all-cause mortality. likelihood of infection whether they receive early antibiotic therapy or not. | Primary outcome measure is 28-day all-cause mortality in persons who receive no antibiotics compared with those who receive early antibiotics in OHCA patients. | 28-day |
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Inclusion Criteria:
● Adults aged >18 years, presenting to HGH ED after out-of-hospital cardiac arrest
Exclusion Criteria:
Patients who have clear evidence of infection, as defined by criteria for the study.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Adeel A Butt, MBBS, MS | Contact | +97433311228 | aabutt@hamad.qa |
| Name | Affiliation | Role |
|---|---|---|
| Adeel A Butt, MBBS, MS | Hamad Medical Corporation | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hamad Medical Corporation | Recruiting | Doha | Baladiyat ad Dawhah | Qatar |
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| ID | Term |
|---|---|
| D001424 | Bacterial Infections |
| D058687 | Out-of-Hospital Cardiac Arrest |
| ID | Term |
|---|---|
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| D006323 | Heart Arrest |
| D006331 | Heart Diseases |
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| with antibiotics treatment | Other | with antibiotics treatment |
|
| D002318 |
| Cardiovascular Diseases |