UMIN-CTR Clinical Trial

Public title

Characteristics, treatment, and outcomes of postoperative patients who required rapid response system intervention: A nationwide database analysis

Acronym

Characteristics, treatment, and outcomes of postoperative patients who required rapid response system intervention: A nationwide database analysis

Scientific Title

Characteristics, treatment, and outcomes of postoperative patients who required rapid response system intervention: A nationwide database analysis

Scientific Title:Acronym

Characteristics, treatment, and outcomes of postoperative patients who required rapid response system intervention: A nationwide database analysis

Region

Japan

Condition

inpatients with rapid response system activation

Classification by specialty

Intensive care medicine

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

To investigate postoperative patients managed by a rapid response system

Basic objectives2

Others

Basic objectives -Others

characteristics, treatment ,outcomes

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

activities of rapid response system (location, trigger criteria, and the outcomes of intervention)

Key secondary outcomes

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

Not applicable

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

All inpatients with rapid response system activation at each institution.

Key exclusion criteria

1) cases registered from long-term care facilities (because of differences in the patient population); 2) outpatients (because of differences in the patient population); 3) cases in which their status was unclear regarding postoperative or non-postoperative grouping.

Target sample size

6784

Name of lead principal investigator

1st name	Yoshiki
Middle name
Last name	SENTO

Organization

Nagoya City University Graduate School of Medical Sciences

Division name

Department of Anesthesiology and Intensive Care Medicine

Zip code

467-8601

Address

1 Kawasumi, Mizuho-cho, Mizuho-ku, Nagoya-city, Aichi, 467-8601, Japan

TEL

0528515511

Email

sentoy@med.nagoya-cu.ac.jp

Name of contact person

1st name	Yoshiki
Middle name
Last name	SENTO

Organization

Nagoya City University Graduate School of Medical Sciences

Division name

Department of Anesthesiology and Intensive Care Medicine

Zip code

467-8601

Address

1 Kawasumi, Mizuho-cho, Mizuho-ku, Nagoya-city, Aichi, 467-8601, Japan

TEL

0528515511

Homepage URL

Email

sentoy@med.nagoya-cu.ac.jp

Institute

Department of Anesthesiology and Intensive Care Medicine, Nagoya City University Graduate School of Medical Sciences

Institute

Department

Personal name

Organization

the Japan Society for the Promotion of Science KAKENHI, the Japanese Society of Intensive Care Medicine and the Japanese Society of Emergency Medicine.

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization

Co-sponsor

In-Hospital Emergency Committee in Japan

Name of secondary funder(s)

Organization

Clinical Research Management Center, Nagoya City University Hospital

Address

1 Kawasumi, Mizuho-cho, Mizuho-ku, Nagoya-city, Aichi, 467-8601, Japan

Tel

0528515511

Email

clinical_research@med.nagoya-cu.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

2020

Year

06

Month

27

Day

URL releasing protocol

https://link.springer.com/article/10.1007/s00540-021-02900-4

Publication of results

Published

URL related to results and publications

https://link.springer.com/article/10.1007/s00540-021-02900-4

Number of participants that the trial has enrolled

4812

Results

There were 609 (12.7%) postoperative patients among the total patients in the registry. The major criteria were staff concerns (30.2%) and low oxygen saturation (29.7%). Hypotension, tachycardia, and inability to contact physicians were observed as triggers significantly more frequently in postoperative patients when compared with non-postoperative patients.

Results date posted

2021

Year

06

Month

29

Day

Results Delayed

Results Delay Reason

Date of the first journal publication of results

Baseline Characteristics

Demographic data were compared between the postoperative and non-postoperative patients (Table 1). The sex ratios were similar between the two groups, but the postoperative patients were significantly older. There was also a significant difference between the two groups in the code status at RRS intervention (p<0.001). According to the residual analysis (performed as a post hoc analysis), in postoperative patients, the rate of full resuscitation was significantly higher (80.1% vs. 71.1%) and that of DNAR was significantly lower (3.3% vs. 9.2%) in comparison to non-postoperative patients (Supplementary Table 1).

Participant flow

A total of 6,784 patients from 35 participating hospitals were reported to the IHER-J from January 2014 to March 2018. In total, 1,972 cases were excluded from the analysis, including 900 cases that were registered from one specific facility equipped with long-term care beds, 682 cases in which the RSS was activated in an outpatient clinic, 329 cases in which the RSS was activated in an ICU, HCU, other subspecialized care unit, or operation room, and 61 cases that were registered as postoperative patients in the database but where other registered data suggested that eight or more days had lapsed since surgery, which resulted in uncertainty regarding postoperative or non-postoperative grouping. Thus, among the total of 4,812 patients from 34 participating hospitals, there were 609 (12.7%) postoperative patients and 4,203 (87.3%) non-postoperative patients (Fig. 1).

Adverse events

none

Outcome measures

Demographic data (sex, age), the code status at the RRS intervention, and details of the RRS activities (trigger criteria, interventions performed by the response team, and the outcomes of RRS intervention)

Plan to share IPD

IPD sharing Plan description

Recruitment status

Completed

Date of protocol fixation

2020

Year

06

Month

27

Day

Date of IRB

2020

Year

07

Month

13

Day

Anticipated trial start date

2020

Year

06

Month

27

Day

Last follow-up date

2020

Year

06

Month

27

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Data on the postoperative period and surgical procedures were collected for postoperative patients where available. Demographics (sex, age), pre-existing code status at the RRS intervention, details regarding the RRS trigger criteria, location of activation of RRS, intervention, and the outcomes of RRS intervention were collected.

Registered date

2020

Year

06

Month

27

Day

Last modified on

2022

Year

01

Month

08

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046721