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Adequacy of Perioperative Cefuroxime Dosage According to the BMI

Primary Purpose

Obesity; Drug

Status

Completed

Phase

Phase 4

Locations

Germany

Study Type

Interventional

Intervention

Cefuroxime 1,5g

Cefuroxime 3g

Cefuroxime 4,5g

About this trial

This is an interventional prevention trial for Obesity; Drug focused on measuring Surgery, Obesity, Drug, Antibiotics, Cefuroxime

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

elective laparoscopic Intervention
BMI < 90 kg/m*m
age: 18-85 years

Exclusion Criteria:

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

Sites / Locations

University Hospital Hamburg-Eppendorf

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Other

Arm Label

Cefuroxime 1,5g

Cefuroxime 3g

Cefuroxime 4,5g

Arm Description

BMI <30kg/m*m

BMI 30-50kg/m*m

BMI >50kg/m*m

Outcomes

Primary Outcome Measures

Serum level of Cefuroxime

Drug Serum Level at skin cut

Serum level of Cefuroxime

Drug Serum Level 45 minutes after skin cut

Serum level of Cefuroxime

Drug Serum Level at the end of surgery

Tissue level of Cefuroxime

Drug Tissue Level at skin cut

Tissue level of Cefuroxime

Drug Tissue Level 45 minutes after skin cut

Tissue level of Cefuroxime

Drug Tissue Level at the end of surgery

Secondary Outcome Measures

Surgical site infections

Incidence of surgical site infections

Hospital Retention period

Length of stay in hospital

Full Information

NCT ID

NCT03141476

First Posted

March 21, 2017

Last Updated

February 19, 2018

Sponsor

Universitätsklinikum Hamburg-Eppendorf

1. Study Identification

Unique Protocol Identification Number

NCT03141476

Brief Title

Adequacy of Perioperative Cefuroxime Dosage According to the BMI

Official Title

Perioperative Cefuroxime in Obese Patients: Dosage According to the BMI

Study Type

Interventional

2. Study Status

Record Verification Date

February 2018

Overall Recruitment Status

Completed

Study Start Date

March 1, 2017 (Actual)

Primary Completion Date

November 12, 2017 (Actual)

Study Completion Date

December 12, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Universitätsklinikum Hamburg-Eppendorf

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

5. Study Description

Brief 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Obesity; Drug

Keywords

Surgery, Obesity, Drug, Antibiotics, Cefuroxime

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Model Description

BMI: <30kg/m*m: 1,5g, 31-50kg/m*m: 3,0g, >50kg/m*m: 4,5g

Masking

None (Open Label)

Allocation

Randomized

Enrollment

60 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Cefuroxime 1,5g

Arm Type

Other

Arm Description

BMI <30kg/m*m

Arm Title

Cefuroxime 3g

Arm Type

Other

Arm Description

BMI 30-50kg/m*m

Arm Title

Cefuroxime 4,5g

Arm Type

Other

Arm Description

BMI >50kg/m*m

Intervention Type

Drug

Intervention Name(s)

Cefuroxime 1,5g

Intervention Description

Patients with BMI of <30kg/m*m: 1,5 g Cefuroxime

Intervention Type

Drug

Intervention Name(s)

Cefuroxime 3g

Intervention Description

Patients with BMI of 30-50kg/m*m: 3g Cefuroxime

Intervention Type

Drug

Intervention Name(s)

Cefuroxime 4,5g

Intervention Description

Patients with BMI of >50kg/m*m: 4,5 g Cefuroxime

Primary Outcome Measure Information:

Title

Serum level of Cefuroxime

Description

Drug Serum Level at skin cut

Time Frame

30-60 minutes after application of cefuroxime

Title

Serum level of Cefuroxime

Description

Drug Serum Level 45 minutes after skin cut

Time Frame

75-105 minutes after application of cefuroxime

Title

Serum level of Cefuroxime

Description

Drug Serum Level at the end of surgery

Time Frame

up to 150 minutes after application of cefuroxime

Title

Tissue level of Cefuroxime

Description

Drug Tissue Level at skin cut

Time Frame

30-60 minutes after application of cefuroxime

Title

Tissue level of Cefuroxime

Description

Drug Tissue Level 45 minutes after skin cut

Time Frame

75-105 minutes after application of cefuroxime

Title

Tissue level of Cefuroxime

Description

Drug Tissue Level at the end of surgery

Time Frame

up to 150 minutes after application of cefuroxime

Secondary Outcome Measure Information:

Title

Surgical site infections

Description

Incidence of surgical site infections

Time Frame

Time until hospital discharge, estimated time period: up to two weeks

Title

Hospital Retention period

Description

Length of stay in hospital

Time Frame

Time until hospital discharge, estimated time period: 5-7 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

85 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: elective laparoscopic Intervention BMI < 90 kg/m*m age: 18-85 years Exclusion Criteria: 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

Facility Information:

Facility Name

University Hospital Hamburg-Eppendorf

City

Hamburg

ZIP/Postal Code

20246

Country

Germany

12. IPD Sharing Statement

Plan to Share IPD

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Adequacy of Perioperative Cefuroxime Dosage According to the BMI

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