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

NCT ID: NCT03408457

Last Updated: 2019-05-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

130 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-03-14

Study Completion Date

2019-05-14

Brief Summary

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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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Detailed Description

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Conditions

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Antibiotic Anti-Bacterial Agents Surgical Wound Infection

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Interventions

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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

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Johannes Gutenberg University Mainz

OTHER

Sponsor Role lead

Responsible Party

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Dr. Serge Thal

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Serge C Thal, MD PhD

Role: PRINCIPAL_INVESTIGATOR

University Medical Center of the Johannes Gutenberg-University Mainz

Locations

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Medical Center of the Johannes Gutenberg-University Mainz

Mainz, Rhineland-Palatinate, Germany

Site Status

Countries

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Germany

Other Identifiers

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U1111-1207-8265

Identifier Type: REGISTRY

Identifier Source: secondary_id

837.402.17 (11236)

Identifier Type: -

Identifier Source: org_study_id

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