Obesity; DrugPhase 4NCT03141476
Adequacy of Perioperative Cefuroxime Dosage According to the BMI
A Phase 4 study testing Cefuroxime 1,5g, Cefuroxime 3g and Cefuroxime 4,5g in people with Obesity; Drug, run by Universitätsklinikum Hamburg-Eppendorf at 1 site in Germany.
Trial summary
This study evaluates the dosage of perioperative cefuroxime for obese patients. Dosage was increased if the BMI was over 30kg/m*m and as well over 50kg/m*m. Drug levels were measured in blood and tissue. Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity; Drug
- What is being tested?
- Cefuroxime 1,5g, Cefuroxime 3g and Cefuroxime 4,5g
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteGermany
- Study dates
- 1 Mar 2017to 12 Dec 2017
- Phase
- Phase 4
- 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 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- elective laparoscopic Intervention
- BMI < 90 kg/m*m
- age: 18-85 years
Who cannot join
- known history of allergy to cefuroxime or other cephalosporines
- absent consent skill
- elective open surgery
- preoperative therapy with antibiotics
- patient's denial of the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Perioperative Cefuroxime in Obese Patients: Dosage According to the BMI
This study evaluates the dosage of perioperative cefuroxime for obese patients. Dosage was increased if the BMI was over 30kg/m*m and as well over 50kg/m*m. Drug levels were measured in blood and tissue.
Read the detailed description
Cefuroxime is an often used antibiotic for surgery antibiotic prophylaxis to avoid surgical wound infection. In this study the dosage of cefuroxime was adjusted to the BMI:
less than 30kg/m*m: 1,5g 31-50kg/m*m: 3,0g more than 50kg/m*m: 4,5g
Cefuroxime was applicated 30 to 60 minutes before the begin of surgery. Drug Levels in blood and fat tissue were measured at skin cut (30-60 minutes after application of Cefuroxime), 45 minutes after skin cut (75-105 minutes after minutes after application of Cefuroxime) and at the end of surgery (up to 150 minutes after application of Cefuroxime) .
The hypothesis of this study is that adequate drug levels are reached in all groups.
- Conditions
- Obesity; Drug
- Being tested
- Cefuroxime 1,5g, Cefuroxime 3g, Cefuroxime 4,5g
- Keywords
- Surgery, Obesity, Drug, Antibiotics, Cefuroxime
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cefuroxime 1,5gDrug
Patients with BMI of <30kg/m*m: 1,5 g Cefuroxime
Cefuroxime 3gDrug
Patients with BMI of 30-50kg/m*m: 3g Cefuroxime
Cefuroxime 4,5gDrug
Patients with BMI of >50kg/m*m: 4,5 g Cefuroxime
| Study group | Role | What they receive |
|---|---|---|
| Cefuroxime 1,5g | Other | BMI <30kg/m*m Receives: Drug: Cefuroxime 1,5g |
| Cefuroxime 3g | Other | BMI 30-50kg/m*m Receives: Drug: Cefuroxime 3g |
| Cefuroxime 4,5g | Other | BMI >50kg/m*m Receives: Drug: Cefuroxime 4,5g |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum level of Cefuroxime
Drug Serum Level at skin cut
Measured: 30-60 minutes after application of cefuroxime
Serum level of Cefuroxime
Drug Serum Level 45 minutes after skin cut
Measured: 75-105 minutes after application of cefuroxime
Serum level of Cefuroxime
Drug Serum Level at the end of surgery
Measured: up to 150 minutes after application of cefuroxime
Tissue level of Cefuroxime
Drug Tissue Level at skin cut
Measured: 30-60 minutes after application of cefuroxime
Tissue level of Cefuroxime
Drug Tissue Level 45 minutes after skin cut
Measured: 75-105 minutes after application of cefuroxime
Tissue level of Cefuroxime
Drug Tissue Level at the end of surgery
Measured: up to 150 minutes after application of cefuroxime
Secondary outcomes (2)
Surgical site infections
Incidence of surgical site infections
Measured: Time until hospital discharge, estimated time period: up to two weeks
Hospital Retention period
Length of stay in hospital
Measured: Time until hospital discharge, estimated time period: 5-7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2017
- Study start1 Mar 2017
- Primary completion12 Nov 2017
- Study completion12 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obesity; DrugStudies of the same condition, open and under way.
- More trials run by Universitätsklinikum Hamburg-EppendorfThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- BMI: \<30kg/m\*m: 1,5g, 31-50kg/m\*m: 3,0g, \>50kg/m\*m: 4,5g
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitätsklinikum Hamburg-Eppendorf
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. med. Jakob Mueller, Universitätsklinikum Hamburg-Eppendorf
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03141476
- Sponsor's protocol ID
- AntibioticsCefuroximePV5153
- Status last verified
- Feb 2018
- First submitted
- 21 Mar 2017
- Last updated
- 20 Feb 2018
- 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 20 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Perioperative Cefuroxime in Obese Patients: Dosage According to the BMI
- ClinicalTrials.gov ID
- NCT03141476
- Acronym / sponsor ID
- AntibioticsCefuroximePV5153
- Conditions
- Obesity; Drug
- Keywords
- Surgery, Obesity, Drug, Antibiotics, Cefuroxime
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Universitätsklinikum Hamburg-EppendorfUniversity, hospital or other
- Study start
- 1 Mar 2017 (actual)
- Primary completion
- 12 Nov 2017 (actual)
- Study completion
- 12 Dec 2017 (actual)
- First posted
- 5 May 2017 (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 the dosage of perioperative cefuroxime for obese patients. Dosage was increased if the BMI was over 30kg/m*m and as well over 50kg/m*m. Drug levels were measured in blood and tissue.
Detailed description
Cefuroxime is an often used antibiotic for surgery antibiotic prophylaxis to avoid surgical wound infection. In this study the dosage of cefuroxime was adjusted to the BMI:
less than 30kg/m*m: 1,5g 31-50kg/m*m: 3,0g more than 50kg/m*m: 4,5g
Cefuroxime was applicated 30 to 60 minutes before the begin of surgery. Drug Levels in blood and fat tissue were measured at skin cut (30-60 minutes after application of Cefuroxime), 45 minutes after skin cut (75-105 minutes after minutes after application of Cefuroxime) and at the end of surgery (up to 150 minutes after application of Cefuroxime) .
The hypothesis of this study is that adequate drug levels are reached in all groups.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- BMI: <30kg/m*m: 1,5g, 31-50kg/m*m: 3,0g, >50kg/m*m: 4,5g
| Arm | Type | Receives |
|---|---|---|
| Cefuroxime 1,5g | Other | Drug: Cefuroxime 1,5gBMI <30kg/m*m |
| Cefuroxime 3g | Other | Drug: Cefuroxime 3gBMI 30-50kg/m*m |
| Cefuroxime 4,5g | Other | Drug: Cefuroxime 4,5gBMI >50kg/m*m |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- elective laparoscopic Intervention
- BMI < 90 kg/m*m
- age: 18-85 years
Key exclusion criteria (5 listed)
- known history of allergy to cefuroxime or other cephalosporines
- absent consent skill
- elective open surgery
- preoperative therapy with antibiotics
- patient's denial of the 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 |
|---|---|---|
| Cefuroxime 1,5gPatients with BMI of <30kg/m*m: 1,5 g Cefuroxime | Drug | Cefuroxime 1,5g |
| Cefuroxime 3gPatients with BMI of 30-50kg/m*m: 3g Cefuroxime | Drug | Cefuroxime 3g |
| Cefuroxime 4,5gPatients with BMI of >50kg/m*m: 4,5 g Cefuroxime | Drug | Cefuroxime 4,5g |
Primary outcome
Serum level of Cefuroxime
Time frame: 30-60 minutes after application of cefuroxime
Drug Serum Level at skin cut
Serum level of Cefuroxime
Time frame: 75-105 minutes after application of cefuroxime
Drug Serum Level 45 minutes after skin cut
Serum level of Cefuroxime
Time frame: up to 150 minutes after application of cefuroxime
Drug Serum Level at the end of surgery
Tissue level of Cefuroxime
Time frame: 30-60 minutes after application of cefuroxime
Drug Tissue Level at skin cut
Tissue level of Cefuroxime
Time frame: 75-105 minutes after application of cefuroxime
Drug Tissue Level 45 minutes after skin cut
Tissue level of Cefuroxime
Time frame: up to 150 minutes after application of cefuroxime
Drug Tissue Level at the end of surgery
2 secondary outcomes
Surgical site infections
Time frame: Time until hospital discharge, estimated time period: up to two weeks
Hospital Retention period
Time frame: Time until hospital discharge, estimated time period: 5-7 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 20 Feb 2018.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Cefuroxime 1,5g, Cefuroxime 3g and Cefuroxime 4,5g in people with Obesity; Drug, run by Universitätsklinikum Hamburg-Eppendorf 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 3 inclusion and 5 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 20 Feb 2018. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 level of Cefuroxime (time frame: 30-60 minutes after application of cefuroxime). The study lists 6 primary outcomes in all. 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 20 Feb 2018.