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OpenTrials
Completed

NCT Number: NCT03408457

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Medical Center of the Johannes Gutenberg-University Mainz

Mainz, Rhineland-Palatinate, 55131, Germany

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Blood sampling after antibiotic administration

Procedure

Sampling of 6 x 8 mL (in sum 48 mL) via the central venous line (established for the surgical procedure) until postoperative day 2

Primary outcomes

  1. Serum concentration of antibiotic

    Time frame: 2 days

    ug/mL

Secondary outcomes

  1. Surgical wound infection

    Time frame: 30 days

    Incidence

Sponsors and collaborators

Lead sponsor

Johannes Gutenberg University Mainz

Other

Registry information

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Jan 24, 2018
Registry last updated
May 30, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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