UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019136 |
|---|---|
| Receipt number | R000022126 |
| Scientific Title | Procalcitonin (PCT) levels and postoperative complications in the scheduled surgery patients; a prospective observational study |
| Date of disclosure of the study information | 2015/10/01 |
| Last modified on | 2024/05/19 19:48:34 |
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Basic information
Public title
Procalcitonin (PCT) levels and postoperative complications in the scheduled surgery patients; a prospective observational study
Acronym
Procalcitonin (PCT) levels in the scheduled surgery patients
Scientific Title
Procalcitonin (PCT) levels and postoperative complications in the scheduled surgery patients; a prospective observational study
Scientific Title:Acronym
Procalcitonin (PCT) levels in the scheduled surgery patients
Region
| Japan |
Condition
Condition
Scheduled surgery patients
Classification by specialty
| Surgery in general | Obstetrics and Gynecology | Dermatology |
| Orthopedics | Urology | Anesthesiology |
| Oral surgery | Neurosurgery | Cardiovascular surgery |
| Plastic surgery | Aesthetic surgery | Intensive care medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To detect relation between levels of PCT and postoperative complications in scheduled surgery patients depending on operative procedure
Basic objectives2
Others
Basic objectives -Others
To detect influencing factors of levels of PCT
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Comparison between PCT levels of Day 1 and with or without postoperative complication, depending on operative procedure
Key secondary outcomes
1) Comparison between PCT and other data as for detecting complications
(2) Evaluation of PCT levels according to severity of disease
(3) Analysis of influencing factors of PCT levels
(4) Relation between survival rate (at Day 28, 60, and 90) and PCT level
(5) Time course of changes in PCT levels
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Scheduled surgery patients who candidates surgical ICU admission
Key exclusion criteria
(1) Predict infectious disease before surgery.
(2) Patients who are exposed to infection factor during the operation.
(3) Emergency surgical patients.
(4) Patients who are judged as inappropriate candidates for the trial by the investigators on preoperative anesthetic consultation.
Target sample size
3000
Research contact person
Name of lead principal investigator
| 1st name | Yoshihito |
| Middle name | |
| Last name | Fujita |
Organization
Aichi Medical University School of Medicine
Division name
Department of Anesthesiology
Zip code
480-1195
Address
1-1 Karimata Yazako Nagakute, Aichi, 480-1195, Japan
TEL
+81-561-62-3311
fujita.yoshihito.823@mail.aichi-med-u.ac.jp
Public contact
Name of contact person
| 1st name | Yoshihito |
| Middle name | |
| Last name | Fujita |
Organization
Aichi Medical University School of Medicine
Division name
Department of Anesthesiology
Zip code
480-1195
Address
1-1 Karimata Yazako Nagakute, Aichi, 480-1195, Japan
TEL
+81-561-62-3311
Homepage URL
fujita.yoshihit.823@mail.aichi-med-u.ac.jp
Sponsor or person
Institute
Aichi Medical University School of Medicine, Department of Anesthesiology
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Aichi Medical University IRB
Address
1-1 Karimata Yazako Nagakute, Aichi, 480-1195, Japan
Tel
+81-561-3311
kanrika@aichi-med-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
| 2015 | Year | 10 | Month | 01 | Day |
Related information
URL releasing protocol
https://upload.umin.ac.jp/cgi-bin/icdr/ctr_up_reg_f5.cgi
Publication of results
Unpublished
Result
URL related to results and publications
https://upload.umin.ac.jp/cgi-bin/icdr/ctr_up_reg_f5.cgi
Number of participants that the trial has enrolled
1900
Results
Until now on 24 April 2021, we could show these preliminary outcomes. We tried to show the detail outcomes as soon as possible. As for about 1900 patients, the patients with late complications had higher level of procalcitonin (PCT). In addition, the cutoff of 0.5 ng/ml of PCT was useful for detecting the late complications after non-cardiac surgeries.
Results date posted
| 2021 | Year | 04 | Month | 24 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
The study was designed as a single-center, prospective, cohort, observational study. All patients scheduled for non-cardiac surgery between December 2015 and March 2017 at our University were screened for the participants.
Participant flow
Before starting to gather patients for inclusion, we picked up optimal surgeries for our study because some surgical procedures do not lead increase of PCT . We chose and investigated the patients of general gastroenterological surgery, thoracic surgery, gynecology, and urology. Therefore, the inclusion criterion was elective general gastroenterological surgery, thoracic surgery, gynecology, and urology. Exclusion criteria comprised: age <18 years, refusal to participate, surgeries suspected of infections, the patients who were exposed to infection factor during the surgery, urgent surgeries and the surgeries except for the upper inclusion surgeries such as cardiac surgery, brain surgery, orthopedic surgery, vascular surgery, breast surgery, cesarean section, endocrine surgery, plastic surgery, ear, nose and throat surgery, and kidney transplant surgery.
Adverse events
This is an observational study. Adverse events were none.
Outcome measures
Until now on 24 April 2021, we could show these preliminary outcomes, briefly. We tried to show the detail outcomes as soon as possible. As for about 1900 patients, the patients with late complications had higher level of procalcitonin (PCT). In addition, the cutoff of 0.5 ng/ml of PCT was useful for detecting the late complications after non-cardiac surgeries.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
No longer recruiting
Date of protocol fixation
| 2015 | Year | 09 | Month | 28 | Day |
Date of IRB
| 2015 | Year | 11 | Month | 24 | Day |
Anticipated trial start date
| 2015 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2019 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
| 2019 | Year | 12 | Month | 31 | Day |
Date analysis concluded
| 2022 | Year | 12 | Month | 31 | Day |
Other
Other related information
Cohort study
Recruitment: all eligible post-operative patients who were sequentially admitted to the general ICU of Aichi Medical University Hospital for 12 months, from January 2016 to December 2016.
Measurement item: PCT,CRP, WBC, body temperature, postoperative complication and so on.
Management information
Registered date
| 2015 | Year | 09 | Month | 28 | Day |
Last modified on
| 2024 | Year | 05 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022126
