AntibioticNCT03408457
Influence of Perioperative Fluid Balance on Serum Concentrations of Antibiotics and Surgical Site Infections
An observational study of Antibiotic and Anti-Bacterial Agents, run by Johannes Gutenberg University Mainz at 1 site in Germany.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Antibiotic, Anti-Bacterial Agents, Surgical Wound Infection
- What is being tested?
- Blood sampling after antibiotic administration
- Type of treatment
- Surgery or procedure
- How many people
- 130 participants
- Where
- 1 siteGermany
- Study dates
- 14 Mar 2018to 14 May 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Study population: Surgical Patients of the University Medical Center Mainz
Who may be able to join
- elective surgery of rectom, esophagus or liver with indication for a central venous catheter
- informed consent
Who cannot join
- pregnancy
- medical emergency
- participation in another study
Trial locations and contacts
1 site in 1 country.
Germany1 site
Medical Center of the Johannes Gutenberg-University Mainz
Mainz, Rhineland-Palatinate, 55131
About this study
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.
- Conditions
- Antibiotic, Anti-Bacterial Agents, Surgical Wound Infection
- Being tested
- Blood sampling after antibiotic administration
- Keywords
- Surgical wound infection, antibiotic concentration, blood level
- Medical subject headings
- Surgical Wound Infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood sampling after antibiotic administrationProcedure or surgery
Sampling of 6 x 8 mL (in sum 48 mL) via the central venous line (established for the surgical procedure) until postoperative day 2
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum concentration of antibiotic
ug/mL
Measured: 2 days
Secondary outcomes (1)
Surgical wound infection
Incidence
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2018
- Study start14 Mar 2018
- Primary completion4 Apr 2019
- Study completion14 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AntibioticStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 130 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johannes Gutenberg University Mainz
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Serge Thal, Johannes Gutenberg University Mainz
- Investigators
- Serge C Thal, MD PhD, Principal investigator, University Medical Center of the Johannes Gutenberg-University Mainz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03408457
- Sponsor's protocol ID
- 837.402.17 (11236)
- Other IDs
- U1111-1207-8265
- Status last verified
- May 2019
- First submitted
- 17 Jan 2018
- Last updated
- 30 May 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Perioperative Fluid Balance on Serum Concentrations of Antibiotics and Surgical Site Infections
- ClinicalTrials.gov ID
- NCT03408457
- Acronym / sponsor ID
- 837.402.17 (11236)
- Conditions
- Antibiotic, Anti-Bacterial Agents, Surgical Wound Infection
- Keywords
- Surgical wound infection, antibiotic concentration, blood level
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 130 participants (actual)
- Lead sponsor
- Johannes Gutenberg University MainzUniversity, hospital or other
- Study start
- 14 Mar 2018 (actual)
- Primary completion
- 4 Apr 2019 (actual)
- Study completion
- 14 May 2019 (actual)
- First posted
- 24 Jan 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Surgical Patients of the University Medical Center Mainz
Key inclusion criteria (2 listed)
- elective surgery of rectom, esophagus or liver with indication for a central venous catheter
- informed consent
Key exclusion criteria (3 listed)
- pregnancy
- medical emergency
- participation in another study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood sampling after antibiotic administrationSampling of 6 x 8 mL (in sum 48 mL) via the central venous line (established for the surgical procedure) until postoperative day 2 | Procedure or surgery | – |
Primary outcome
Serum concentration of antibiotic
Time frame: 2 days
ug/mL
1 secondary outcome
Surgical wound infection
Time frame: 30 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Serge C Thal, MD PhD principal investigator
University Medical Center of the Johannes Gutenberg-University Mainz
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Antibiotic and Anti-Bacterial Agents, run by Johannes Gutenberg University Mainz at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 May 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Serum concentration of antibiotic (time frame: 2 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 May 2019.