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

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ClinicalTrials.gov Identifier: NCT03408457
Recruitment Status : Completed
First Posted : January 24, 2018
Last Update Posted : May 30, 2019
Sponsor:
Information provided by (Responsible Party):
Dr. Serge Thal, 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.

Condition or disease Intervention/treatment
Antibiotic Anti-Bacterial Agents Surgical Wound Infection Procedure: Blood sampling after antibiotic administration

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Study Type : Observational
Actual Enrollment : 130 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Influence of Perioperative Fluid Balance on Serum Concentrations of Antibiotics and Surgical Site Infections
Actual Study Start Date : March 14, 2018
Actual Primary Completion Date : April 4, 2019
Actual Study Completion Date : May 14, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Antibiotics


Intervention Details:
  • 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


Primary Outcome Measures :
  1. Serum concentration of antibiotic [ Time Frame: 2 days ]
    ug/mL


Secondary Outcome Measures :
  1. Surgical wound infection [ Time Frame: 30 days ]
    Incidence


Biospecimen Retention:   Samples Without DNA
Blood samples


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Probability Sample
Study Population
Surgical Patients of the University Medical Center Mainz
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03408457


Locations
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Germany
Medical Center of the Johannes Gutenberg-University Mainz
Mainz, Rheinland-Pfalz, Germany, 55131
Sponsors and Collaborators
Johannes Gutenberg University Mainz
Investigators
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Principal Investigator: Serge C Thal, MD PhD University Medical Center of the Johannes Gutenberg-University Mainz

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Responsible Party: Dr. Serge Thal, Principal Investigator, Johannes Gutenberg University Mainz
ClinicalTrials.gov Identifier: NCT03408457     History of Changes
Other Study ID Numbers: 837.402.17 (11236)
U1111-1207-8265 ( Registry Identifier: UTN )
First Posted: January 24, 2018    Key Record Dates
Last Update Posted: May 30, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Dr. Serge Thal, Johannes Gutenberg University Mainz:
Surgical wound infection
antibiotic concentration
blood level

Additional relevant MeSH terms:
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Anti-Bacterial Agents
Antibiotics, Antitubercular
Infection
Communicable Diseases
Surgical Wound Infection
Wound Infection
Surgical Wound
Postoperative Complications
Pathologic Processes
Wounds and Injuries
Anti-Infective Agents
Antitubercular Agents