The comparison between short and long infusion of Ampicillin-Sulbactam in patients with sepsis and severe sepsis in the intensive care unit of Namazee and shahid Rajaee hospital in Shiraz.
Phase 3
Recruiting
- Conditions
- Condition 1: Severe Sepsis. Condition 2: Sepsis.Severe sepsisSepsis, unspecified organismR65.2A41.9
- Registration Number
- IRCT20190425043368N1
- Lead Sponsor
- Shiraz University of Medical Sciences
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 136
Inclusion Criteria
More than 18 years old
Diagnosis of sepsis and severe sepsis based on qSOFA criteria
Taking Ampicillin- Sulbactam at least for three days
Exclusion Criteria
Pregnancy
Sensitivity to Ampicillin- Sulbactam
Receiving Ampicillin- Sulbactam more than 24 hours during 1 week before being admitted to the intensive care unit
Patients with GFR<10 ml/min or hemodialysis
Patients with Pseudomonas, penicillin-resistant staph aureus (MRSA), or stenotrophomonas
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Clinical cure (resolution of signs and symptoms related to the infection, including hypothermia or hyperthermia, low platelet count, high heart rate, high respiratory rate or low PaCO2, abnormal white blood cell count and positive microbial culture. Timepoint: At the end of therapy and 14 days after cessation of antibiotic. Method of measurement: Individual examination, measuring temperature by thermometer, complete blood count and determination of platelet and white blood cell count, measurement of heart rate and respiratory rate, analysis of blood gases, microbial culture.
- Secondary Outcome Measures
Name Time Method