24 Vs 48 Hours of Cefazolin or Cefuroxime as Prophylaxis
Study Details
Study Description
Brief Summary
A randomized control trial studying the effect of prophylactic antibiotics to reduce surgical site infections following cardiac surgery in adults using 1st generation cephalosporin (Cefazolin) or 2nd generation cephalosporin (Cefuroxime).
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 4 |
Detailed Description
A prospective randomized controlled patient blinded study with 2x2 factional design. It aims to study optimal duration of antibiotic to reduce surgical site infections following cardiac surgery in adults 24 or 48 hours using 1st generation cephalosporin (Cefazolin) or 2nd generation cephalosporin (Cefuroxime). Patients shall remain on either medicines for 24 or 48 hours. The primary endpoints of the study are:(1) 48 hours antibiotic prophylaxis is superior to 24 hours in adult cardiac surgery (2) Cefuroxime is superior to Cafazolin as a prophylactic antibiotic in adult cardiac surgery. Secondary endpoints include; organisms causing surgical site infections, length of hospital and ICU stay, and worsening in renal function.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: 24 hour Cefuroxime arm 25% of the entire study participants are assigned to 24 hours and second generation cephalosporin |
Drug: Cefuroxime
second generation cephalosporin
Other: 24 hours
Duration of antibiotic therapy
|
| Active Comparator: 24 hour Cefazolin arm 25% of the entire study participants are assigned to 24 hours and first generation cephalosporin |
Drug: Cefazolin
First generation cephalosporin
Other: 24 hours
Duration of antibiotic therapy
|
| Active Comparator: 48 hour Cefuroxime arm 25% of the entire study participants are assigned to 48 hours and second generation cephalosporin |
Drug: Cefuroxime
second generation cephalosporin
Other: 48 hours
Duration of antibiotic therapy
|
| Active Comparator: 48 hour Cefazolin arm 25% of the entire study participants are assigned to 48 hours and first generation cephalosporin |
Drug: Cefazolin
First generation cephalosporin
Other: 48 hours
Duration of antibiotic therapy
|
Outcome Measures
Primary Outcome Measures
- surgical site infection rate is less with Cefuroxime than Cefazolin [within 3 months from date of surgery]
that Second Generation Cefalosporin is superior to first generation
- surgical site infection rate is less with 48 hours rather than 24 hours [within 3 months from date of surgery]
That Longer duration of prophylaxis is better than shorter duration
Secondary Outcome Measures
- Length of actual Hospital Stay in the group assigned to 48 hours of cefuroxime [within 3 months from date of surgery]
that 48 hours of cefuroxime will reduce hospital stay
- Length of ICU Stay will be shorter in the group assigned to 48 hours of cefuroxime [within 3 months from date of surgery]
that 48 hours of cefuroxime will reduce ICU stay
- rate of infection with a specific organism following each of the antibiotics used [within 3 months from date of surgery]
type of organism following each type of antibiotic used
- change from baseline of serum creatinine for each antibiotic used [within 3 months from date of surgery]
that 48 hours of cefuroxime will not worsen renal function
- Mortality rate associated with use of each antibiotic used [within 3 months from date of surgery]
that 48 hours of cefuroxime might reduce mortality
- rate of infection other than surgical site following each of the antibiotics used [within 3 months from date of surgery]
that this will not be affected by the antibiotic used
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Ability to provide informed consent
-
Planned to undergo a cardiac surgical procedure
Exclusion Criteria:
-
Patients on antibiotics on the day of surgery or those who received any within 7 days for any reason
-
Patients taken to operating room as salvage
-
Patients who are allergic to either cefuroxime or cefazolin
-
Patients for LVAD or ECMO
-
Patients who are known MRSA carriers
-
Patients receiving steroid therapy
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Saud AlBabtain Cardiac Center | Dammam | Eastern Province | Saudi Arabia | 31463 |
Sponsors and Collaborators
- Saud Al Babtain Cardiac Center
Investigators
- Principal Investigator: Mohammed S Koudieh, MD, Saud AlBabtain Cardiac Center
- Principal Investigator: Shukri M AlSaif, MD, Saud AlBabtain Cardiac Center
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- SBCC-2017-14