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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04931914
Other study ID # 203
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 4, 2020
Est. completion date December 25, 2020

Study information

Verified date November 2022
Source University of Alexandria
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

adding pharmaceutical services to patient care and changing the professional activity of pharmacists from drug-focused to patient-oriented care,in the current study, clinical pharmacists will be assigned to monitor pharmacotherapy regimens, participate in patient care, and cooperate in educating the staff and evaluating care.


Description:

During the intervention period, the pharmacist attended daily unit rounds with ICU intensivist with a focus on optimization of antibiotic regimens. Pharmacist consultative services were also available by phone calls 24 hours x 7 days if needed. For every patient surgical prophylactic antibiotic initiated immediately before surgery and continued for 48 hours following surgery. Antibiotic therapy had given as either directed or empiric. Directed therapy was defined as treatment of a documented infection based on culture and sensitivity. Empiric therapy was defined as any antibiotic therapy administered when no documented infection was present, and the patient had clinically suspected infection following surgery. Empiric antibiotic administration was required in majority of our SICU patients. Antibiotics had given after exclusion of allergy by history and intradermal sensitivity test.


Recruitment information / eligibility

Status Completed
Enrollment 300
Est. completion date December 25, 2020
Est. primary completion date December 5, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years to 80 Years
Eligibility Inclusion Criteria: - all admitted patients to the ICU between age 18-80 years old Exclusion Criteria: - Patient admitted for less than 24 hours (including deaths and transfers) will be excluded from the study. Pediatric patients weighted less than kilograms.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Clinical pharmacy sharing in the patient care regimen
antibiotic regimens will be directed by a trained clinical pharmacist recommendation and supported by intensivist.

Locations

Country Name City State
Egypt Alexandria university Alexandria

Sponsors (1)

Lead Sponsor Collaborator
University of Alexandria

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary Antibiotics consumption consumption will be counted as number of defined daily doses (DDD), expressed as DDD per 100 patient-days 1 year
Primary Average length of stay the average number of days that patients spent in SICU. 1 year
Primary Mortality rate The number of deaths of patients admitted to SICU, divided by the number of admissions. 1 year
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