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

Exploratory study on pharmacokinetics of cefmetazole in over-weight or under-weight patients as prophylactic antibiotics for surgical site infection after lower gastrointestinal surgery

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCTs061200055
Enrollment
30
Registered
2021-02-16
Start date
2021-04-27
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Interventions

Cefmetazole is administered intravenously as prophylactic antibiotics. The dose based on recommendation of the guideline. For patients weighing over 80 kg, use a single dose of 2 grams of cefmetazole.
Lower gastrointestinal surgery, surgical site infection, cefmetazole

Sponsors

Ohge Hiroki
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

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

Design outcomes

Primary

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

Contacts

Public ContactUegami Shinnosuke

Hiroshima University graduate school

suegami@hiroshima-u.ac.jp+81-82-257-5216

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026