Study on pharmacokinetics of cefmetazole for over-weight or under-weight patients

Not Applicable

Recruiting

• Conditions: lower gastrointestinal disease with surgical indication (regardless of benign or malignant); Lower gastrointestinal surgery, surgical site infection

• Registration Number: JPRN-jRCTs061200055
• Lead Sponsor: Ohge Hiroki

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-02-16
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

1 Patients scheduled for elective lower gastrointestinal surgery (regardless of open surgery or laparoscopic surgery)
2 Patients weight over 80 kg and BMI 25 kg/m2 or weight less than 40kg and BMI 18.5 kg/m2 or patients excluding weight and BMI already shown.
3 Patients over 20 years old, regardless of gender
4 Patients who can give written informed consent to participate in this study

Exclusion Criteria

1 Patients with a history of allergies to Cefmetazole
2 Patients with a history of allergies to cephems
3 Patients who take drugs require caution in combination use
4 Patients who are pregnant or nursing
5 Patients with diseases in the brain and spinal cord
6 Patients with renal dysfunction who have creatinine clearance less than 50 ml / min estimated by Cockcroft-Gault equation (Use ideal body weight for patients weighing over 80kg)
7 Patients judged inappropriate for this study by the researcher

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Pharmacokinetic parameters (Cmax, AUC, T1/2, Tmax) of drug in plasma, peritoneal fluid and abdominal tissues (peritoneum and subcutaneous adipose tissue)