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NCT03408457 Clinical Trial

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

Surgical Wound Infection Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03408457
Other study ID # 837.402.17 (11236)
Secondary ID U1111-1207-8265
Status Completed
Phase
First received
Last updated
Start date March 14, 2018
Est. completion date May 14, 2019

Study information
Verified date May 2019
Source Johannes Gutenberg University Mainz
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 130
Est. completion date May 14, 2019
Est. primary completion date April 4, 2019
Accepts healthy volunteers
Gender All
Age group 18 Years and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

Procedure:
• Blood sampling after antibiotic administration
Sampling of 6 x 8 mL (in sum 48 mL) via the central venous line (established for the surgical procedure) until postoperative day 2

Locations
Country Name City State
Germany Medical Center of the Johannes Gutenberg-University Mainz Mainz Rheinland-Pfalz

Sponsors (1)
Lead Sponsor Collaborator
Johannes Gutenberg University Mainz

Country where clinical trial is conducted

Germany, 

Outcome
Type Measure Description Time frame Safety issue
Primary Serum concentration of antibiotic ug/mL 2 days
Secondary Surgical wound infection Incidence 30 days
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