Empiric Antibiotic Treatment for Septic Patients in the Intensive Care Unit

Recruiting

• Conditions: Septic Patients Admitted to the ICU
• Interventions: Other: empiric antibiotic therapy

• Registration Number: NCT05924126
• Lead Sponsor: Meir Medical Center

Brief Summary

Sepsis is one of the most common causes of ICU admission. About 5-15% of patients admitted to the hospital with an infection will have sepsis, and about 30-40% of them will have septic shock. About 34% of septic patients and about 53% of patients with septic shock will die within 28 days of admission. Broad-spectrum empiric antibiotic treatment (depending on the source of infection and patient risk factors) is one of the cornerstones of sepsis management. According to the recommendations of the surviving sepsis campaign, empiric antibiotic treatment should be given within one hour of the patient's arrival for patients with sepsis or septic shock. Administration of inappropriate antibiotics in the first 24 hours of admission was found in 34% of septic patients in various studies, and administration of inappropriate antibiotics (or when administered in delay) was found to be associated with increased morbidity and mortality.

In this study, we will assess the proportion of patients who were admitted to the ICU due to sepsis or septic shock and received empiric antibiotic treatment which, in retrospect, according to the growth in the cultures later on, was inappropriate. We will also assess the therapeutic results in these patients - mainly significant morbidity and mortality within 28 days, and compare them to the group of patients who received appropriate antibiotic therapy. We would also like to assess what were the possible reasons for inappropriate empiric antibiotic treatment, in order to draw conclusions to reduce the rate of these cases.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-06-20
• Study First Submitted QC: 2023-06-20
• Study First Posted: 2023-06-29
• Study Start: 2024-01-01
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-13
• Last Update Posted: 2024-03-15
• Primary Completion: 2025-09
• Study Completion: 2025-09

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 155

Inclusion Criteria

• All patients admitted to the general ICU due to sepsis or septic shock between 1/1/20 and 31/12/20

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Exclusion Criteria

Patients who were admitted due to other non-infectious etiologies

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
septic patients who recieved appropriate empiric antibiotics	empiric antibiotic therapy	-

Primary Outcome Measures

Name	Time	Method
Proportion of septic patients who recieved inappropriate empiric antibiotic therapy	January 2020-December 2020	Proportion of septic patients who recieved inappropriate empiric antibiotic therapy

Trial Locations

Locations (1)

Meir Medical Center; 🇮🇱 Kfar Saba, Israel