Influence of Perioperative Fluid Balance on Serum Concentrations of Antibiotics and Surgical Site Infections

Completed

• Conditions: Anti-Bacterial Agents; Surgical Wound Infection; Antibiotic

• Registration Number: NCT03408457
• Lead Sponsor: Johannes Gutenberg University Mainz

Brief Summary

This study evaluates antibiotic serum concentrations in correlation with perioperative fluid balance. Patients will be recruited in rectum and esophageal surgery (representative for low blood loss and restrictive fluid management) and in liver surgery (representative for high blood loss and liberal fluid management). The hypothesis is that high blood loss and liberal fluid management dilute antibiotic serum concentrations thereby potentially increasing surgical site infections.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-01-17
• Study First Submitted QC: 2018-01-17
• Study First Posted: 2018-01-24
• Study Start: 2018-03-14
• Primary Completion: 2019-04-04
• Status Verified: 2019-05
• Study Completion: 2019-05-14
• Last Update Submitted: 2019-05-28
• Last Update Posted: 2019-05-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 130

Inclusion Criteria

• elective surgery of rectom, esophagus or liver with indication for a central venous catheter
• informed consent

Exclusion Criteria

• pregnancy
• medical emergency
• participation in another study

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Serum concentration of antibiotic	2 days	ug/mL

Secondary Outcome Measures

Name	Time	Method
Surgical wound infection	30 days	Incidence

Trial Locations

Locations (1)

Medical Center of the Johannes Gutenberg-University Mainz; 🇩🇪 Mainz, Rheinland-Pfalz, Germany