NCT03408457

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
130

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 17, 2018

Completed
7 days until next milestone

First Posted

Study publicly available on registry

January 24, 2018

Completed
2 months until next milestone

Study Start

First participant enrolled

March 14, 2018

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 4, 2019

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 14, 2019

Completed
Last Updated

May 30, 2019

Status Verified

May 1, 2019

Enrollment Period

1.1 years

First QC Date

January 17, 2018

Last Update Submit

May 28, 2019

Conditions

AntibioticAnti-Bacterial AgentsSurgical Wound Infection

Keywords

Surgical wound infectionantibiotic concentrationblood level

Outcome Measures

Primary Outcomes (1)

  • Serum concentration of antibiotic

    ug/mL

    2 days

Secondary Outcomes (1)

  • Surgical wound infection

    30 days

Interventions

Blood sampling after antibiotic administrationPROCEDURE

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

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Surgical Patients of the University Medical Center Mainz

You may qualify if:

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

You may not qualify if:

  • pregnancy
  • medical emergency
  • participation in another study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical Center of the Johannes Gutenberg-University Mainz

Mainz, Rhineland-Palatinate, 55131, Germany

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood samples

MeSH Terms

Conditions

Surgical Wound Infection

Condition Hierarchy (Ancestors)

Wound InfectionInfectionsPostoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Serge C Thal, MD PhD

    University Medical Center of the Johannes Gutenberg-University Mainz

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 17, 2018

First Posted

January 24, 2018

Study Start

March 14, 2018

Primary Completion

April 4, 2019

Study Completion

May 14, 2019

Last Updated

May 30, 2019

Record last verified: 2019-05

Data Sharing

IPD Sharing
Will not share

Locations

DE(1)