Prolonged Intravenous Infusion of β-lactam Antibiotics in Early Septic Patients

NCT05024565 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 2600

Last updated 2021-08-27

No results posted yet for this study

Summary

The prolonged β-lactam Antibiotics intravenous infusion strategy has emerged as the standard treatment for sepsis despite its unknown efficacy. The investigators will conduct a prospective, multi-center, cluster randomized controlled clinical trial. The investigators aimed to compare the clinical efficacy and prognosis of prolonged β-lactam antibiotics intravenous infusion versus short-term intravenous infusion in ICU patients with early sepsis. The investigators expect to recruit 40 branch centers and enroll at least 2600 patients with sepsis.

Conditions

Interventions

BEHAVIORAL

prolonged intravenous infusion of β-lactams Antibiotics

(1) Carbapenems: Calculate the daily dose according to the creatinine clearance rate and divide it into 3 times. Each time, the dose is injected intravenously at 1/2 dose for 15 minutes, and the remaining 1/2 dose is injected at a constant rate for 3 hours. (2) Cephalosporins: calculate the allowable daily dose according to the creatinine clearance rate, inject at a uniform rate within 24 hours. (3) β-lactams and β-lactamase inhibitor compound: the daily dose is calculated according to the creatinine clearance rate and injected at a uniform rate within 24 hours.

Sponsors & Collaborators

  • Qilu Hospital of Shandong University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-09-20
Primary Completion
2022-12-31
Completion
2023-09-01

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05024565 on ClinicalTrials.gov