UMIN-CTR Clinical Trial

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

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

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

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

Study type

Observational

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

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

Email

fujita.yoshihito.823@mail.aichi-med-u.ac.jp

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

Email

fujita.yoshihit.823@mail.aichi-med-u.ac.jp

Institute

Aichi Medical University School of Medicine, Department of Anesthesiology

Institute

Department

Personal name

Organization

None

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Aichi Medical University IRB

Address

1-1 Karimata Yazako Nagakute, Aichi, 480-1195, Japan

Tel

+81-561-3311

Email

kanrika@aichi-med-u.ac.jp

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2015

Year

10

Month

01

Day

URL releasing protocol

https://upload.umin.ac.jp/cgi-bin/icdr/ctr_up_reg_f5.cgi

Publication of results

Unpublished

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

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

Date trial data considered complete

Date analysis concluded

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.

Registered date

2015

Year

09

Month

28

Day

Last modified on

2021

Year

04

Month

24

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022126