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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000029273
Receipt No. R000032382
Scientific Title Pharmacokinetics of nitroimidazole antibacterial agent Metronidazole as intraoperative prophylaxis for colorectal surgery
Date of disclosure of the study information 2017/09/25
Last modified on 2019/04/01

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Basic information
Public title Pharmacokinetics of nitroimidazole antibacterial agent Metronidazole as intraoperative prophylaxis for colorectal surgery
Acronym Pharmacokinetics of Metronidazole as intraoperative prophylaxis for colorectal surgery
Scientific Title Pharmacokinetics of nitroimidazole antibacterial agent Metronidazole as intraoperative prophylaxis for colorectal surgery
Scientific Title:Acronym Pharmacokinetics of Metronidazole as intraoperative prophylaxis for colorectal surgery
Region
Japan

Condition
Condition colorectal disease with surgical indication (both benign and malignant)
Classification by specialty
Hepato-biliary-pancreatic surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 We measure the transition of blood concentration, ascites concentration, tissue concentration (subcutaneous fat and peritoneum) of Metronidazole when it is administered as antibiotic prophylaxis in patients undergoing elective colorectal surgery.
Subsequently, we examine the relationship between the distribution of Metronidazole during surgery and MIC for anaerobic bacteria, and the necessity of additional administration.
Basic objectives2 PK,PD
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Pharmacokinetic parameters (Cmax, AUC, t1 / 2, tmax) of Metronidazole in blood, ascites and tissue (subcutaneous fat and peritoneum)
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Prevention
Type of intervention
Medicine
Interventions/Control_1 Patients are given intravenous drip infusion of Cefazolin 1 g and Metronidazole 500 mg as intraoperative antibiotic prophylaxis.
Blood (about 2 ml), ascites (about 2 ml), subcutaneous fat (about 4 mm cube) and peritoneum (about 4 mm square) are collected at the beginning of surgery (after laparotomy) and every hour thereafter and at the end of the surgery. Then we measure the Metronidazole concentration of each specimen.
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria ・Patients scheduled for elective colorectal surgery(limited to open surgery cases)
・Inpatients over 20 years old who agree to participate in this study, regardless of gender
・Patients who can give written informed consent to participate in this study
Key exclusion criteria ・Emergency surgical patient
・Patients requiring extensive small intestine resection
・Patients requiring excision of other organs
・Patients with complications leading to a decrease in liver function
・Patients with a history of allergies to Cefazolin or Metronidazole
・Combined use of Cefazolin or Metronidazole caution drug
・Patients who are pregnant or nursing
・Patients with organic diseases in the brain and spinal cord
・Patients judged inappropriate for this study by the researcher
Target sample size 10

Research contact person
Name of lead principal investigator
1st name Hiroki
Middle name
Last name Ohge
Organization Hiroshima University Hospital
Division name Department of Infectious Diseases
Zip code 734-8551
Address 1-2-3,Kasumi, Minami-ku Hiroshima-shi, Hiroshima
TEL 082-257-1613
Email ohge@hiroshima-u.ac.jp

Public contact
Name of contact person
1st name Hiroyuki
Middle name
Last name Taogoshi
Organization Hiroshima University graduate school
Division name Department of Surgery, Applied Life Sciences Institute of Biomedical & Health Sciences
Zip code 734-8551
Address 1-2-3,Kasumi, Minami-ku Hiroshima-shi, Hiroshima
TEL 082-257-5216
Homepage URL
Email d172952@hiroshima-u.ac.jp

Sponsor
Institute Department of Infectious Diseases, Hiroshima University Hospital
Institute
Department

Funding Source
Organization Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Center for integrated medical research, Hiroshima University Hospital
Address 1-2-3,Kasumi, Minami-ku Hiroshima-shi, Hiroshima
Tel 082-257-1752
Email protocol@cimr.hiroshima-u.ac.jp

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2017 Year 09 Month 25 Day

Related information
URL releasing protocol
Publication of results Partially published

Result
URL related to results and publications
Number of participants that the trial has enrolled 10
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status No longer recruiting
Date of protocol fixation
2017 Year 09 Month 25 Day
Date of IRB
2017 Year 09 Month 14 Day
Anticipated trial start date
2017 Year 09 Month 25 Day
Last follow-up date
2018 Year 10 Month 31 Day
Date of closure to data entry
2019 Year 09 Month 30 Day
Date trial data considered complete
2019 Year 09 Month 30 Day
Date analysis concluded
2019 Year 09 Month 30 Day

Other
Other related information

Management information
Registered date
2017 Year 09 Month 25 Day
Last modified on
2019 Year 04 Month 01 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032382

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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