Clinical trial NCT04303390: 24 Vs 48 Hours of Cefazolin or Cefuroxime as Prophylaxis
Official title: 24 Versus 48 Hours of First Generation or Second Generation Cephalosporin as Prophylaxis to Reduce Surgical Site Infection in Adult Cardiac Surgery Patients: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Surgical Site Infection
Lead sponsor: Saud Al Babtain Cardiac Center
Sponsor class: OTHER_GOV
First posted: 2020-03-11
Enrollment: 568
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 50% of study patients will be assigned to first generation cephalosporin while the other 50% will be assigned to the second generation cephalosporin. 50% of the entire study participants will be assigned to 24 hour therapy while the other 50% will be assigned to 48 hours
Primary purpose: TREATMENT

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).

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.

Eligibility 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

Primary outcomes:
measure: surgical site infection rate is less with Cefuroxime than Cefazolin
timeFrame: within 3 months from date of surgery
measure: surgical site infection rate is less with 48 hours rather than 24 hours
timeFrame: within 3 months from date of surgery
Secondary outcomes:
measure: Length of actual Hospital Stay in the group assigned to 48 hours of cefuroxime
timeFrame: within 3 months from date of surgery
measure: Length of ICU Stay will be shorter in the group assigned to 48 hours of cefuroxime
timeFrame: within 3 months from date of surgery
measure: rate of infection with a specific organism following each of the antibiotics used
timeFrame: within 3 months from date of surgery
measure: change from baseline of serum creatinine for each antibiotic used
timeFrame: within 3 months from date of surgery
Other outcomes:
Locations:
city: Dammam
country: Saudi Arabia
facility: Saud AlBabtain Cardiac Center
state: Eastern Province
Study officials:
affiliation: Saud AlBabtain Cardiac Center
name: Mohammed S Koudieh, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Saud AlBabtain Cardiac Center
name: Shukri M AlSaif, MD
role: PRINCIPAL_INVESTIGATOR
References: