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Completed

NCT Number: NCT03141476

Adequacy of Perioperative Cefuroxime 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.

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Key information

Conditions

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

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

University Hospital Hamburg-Eppendorf

Hamburg, 20246, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cefuroxime 1,5g

Drug

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

Cefuroxime 3g

Drug

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

Cefuroxime 4,5g

Drug

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

Primary outcomes

  1. Serum level of Cefuroxime

    Time frame: 30-60 minutes after application of cefuroxime

    Drug Serum Level at skin cut

  2. Serum level of Cefuroxime

    Time frame: 75-105 minutes after application of cefuroxime

    Drug Serum Level 45 minutes after skin cut

  3. Serum level of Cefuroxime

    Time frame: up to 150 minutes after application of cefuroxime

    Drug Serum Level at the end of surgery

  4. Tissue level of Cefuroxime

    Time frame: 30-60 minutes after application of cefuroxime

    Drug Tissue Level at skin cut

  5. Tissue level of Cefuroxime

    Time frame: 75-105 minutes after application of cefuroxime

    Drug Tissue Level 45 minutes after skin cut

  6. Tissue level of Cefuroxime

    Time frame: up to 150 minutes after application of cefuroxime

    Drug Tissue Level at the end of surgery

Secondary outcomes

  1. Surgical site infections

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

    Incidence of surgical site infections

  2. Hospital Retention period

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

    Length of stay in hospital

Sponsors and collaborators

Lead sponsor

Universitätsklinikum Hamburg-Eppendorf

Other

Registry information

Official study title

Perioperative Cefuroxime in Obese Patients: Dosage According to the BMI

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
May 5, 2017
Registry last updated
Feb 20, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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