UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029273 |
|---|---|
| Receipt number | 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 | 2019/08/01 18:23:52 |
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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
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
d172952@hiroshima-u.ac.jp
Sponsor or person
Institute
Department of Infectious Diseases, Hiroshima University Hospital
Institute
Department
Personal name
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
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
Completed
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 | 09 | Month | 30 | Day |
Date of closure to data entry
| 2020 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2020 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2020 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2017 | Year | 09 | Month | 25 | Day |
Last modified on
| 2019 | Year | 08 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032382
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| Registered date | File name |
| Research case data | |
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