Adequacy of Perioperative Cefuroxime Dosage According to the BMI

NCT03141476 | Completed Phase 4

• 1 other identifier: AntibioticsCefuroximePV5153
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity; Drug

Keywords

Surgery; Obesity; Drug; Antibiotics; Cefuroxime

Outcome Measures

Primary Outcomes (6)

• Serum level of Cefuroxime

  Drug Serum Level at skin cut

  30-60 minutes after application of cefuroxime

• Serum level of Cefuroxime

  Drug Serum Level 45 minutes after skin cut

  75-105 minutes after application of cefuroxime

• Serum level of Cefuroxime

  Drug Serum Level at the end of surgery

  up to 150 minutes after application of cefuroxime

• Tissue level of Cefuroxime

  Drug Tissue Level at skin cut

  30-60 minutes after application of cefuroxime

• Tissue level of Cefuroxime

  Drug Tissue Level 45 minutes after skin cut

  75-105 minutes after application of cefuroxime

• Tissue level of Cefuroxime

  Drug Tissue Level at the end of surgery

  up to 150 minutes after application of cefuroxime

Secondary Outcomes (2)

• Surgical site infections

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

• Hospital Retention period

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

Study Arms (3)

Cefuroxime 1,5g

OTHER

BMI \<30kg/m\*m

Drug: Cefuroxime 1,5g

Cefuroxime 3g

OTHER

BMI 30-50kg/m\*m

Drug: Cefuroxime 3g

Cefuroxime 4,5g

OTHER

BMI \>50kg/m\*m

Drug: Cefuroxime 4,5g

Interventions

Cefuroxime 1,5g DRUG

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

Cefuroxime 1,5g

Cefuroxime 3g DRUG

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

Cefuroxime 3g

Cefuroxime 4,5g DRUG

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

Cefuroxime 4,5g

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Universitätsklinikum Hamburg-Eppendorf: lead

Study Sites (1)

University Hospital Hamburg-Eppendorf

Hamburg, 20246, Germany

Location

MeSH Terms

Conditions

Obesity

Interventions

Cefuroxime

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cephalosporins; beta-Lactams; Lactams; Amides; Organic Chemicals; Thiazines; Sulfur Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Physician

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

Study Record Dates

• First Submitted: March 21, 2017
• First Posted: May 5, 2017
• Study Start: March 1, 2017
• Primary Completion: November 12, 2017
• Study Completion: December 12, 2017
• Last Updated: February 20, 2018

Record last verified: 2018-02

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)