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CompletedNCT03408457Updated May 30, 2019

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

An observational study in Antibiotic, Anti-Bacterial Agents and Surgical Wound Infection, sponsored by Johannes Gutenberg University Mainz. Completed at 1 site in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-05-30.

Sponsored by Johannes Gutenberg University Mainz · Observational

Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
130
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Antibiotic
  • Anti-Bacterial Agents
  • Surgical Wound Infection

Keywords

  • Surgical wound infection
  • antibiotic concentration
  • blood level
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Sampling method
Probability sample

Study population

Surgical Patients of the University Medical Center Mainz

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • pregnancy
  • medical emergency
  • participation in another study
04

Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
130 participants (actual)
Patient registry
No
Biospecimen retention
Samples without dna

Interventions

  • ProcedureBlood 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

05

What researchers measure

Primary outcomes

  1. Serum concentration of antibiotic

    ug/mL

    Time frame: 2 days

Secondary outcomes

  1. Surgical wound infection

    Incidence

    Time frame: 30 days

06

Study locations

1 site
  • Medical Center of the Johannes Gutenberg-University Mainz
    Mainz, Rheinland-Pfalz 55131, Germany
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT03408457
Lead sponsor
Johannes Gutenberg University Mainz
Responsible party
Dr. Serge Thal (Principal Investigator, Johannes Gutenberg University Mainz) — Principal investigator
First posted
Jan 24, 2018
Start date
Mar 14, 2018
Primary completion
Apr 4, 2019
Completion
May 14, 2019
Last update
May 30, 2019

Study contacts

Serge C Thal, MD PhD
principal investigator · University Medical Center of the Johannes Gutenberg-University Mainz

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2019. You cannot join it, but the record below documents what was studied.

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