UMIN-CTR Clinical Trial

Basic information
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
Condition	inpatients with rapid response system activation
Classification by specialty	Intensive care medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
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

Assessment
Primary outcomes	activities of rapid response system (location, trigger criteria, and the outcomes of intervention)
Key secondary outcomes

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	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

Research contact person
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

Public contact
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

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

Funding Source
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

Other related organizations
Co-sponsor	In-Hospital Emergency Committee in Japan
Name of secondary funder(s)

IRB Contact (For public release)
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
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	2020 Year 06 Month 27 Day

Related information
URL releasing protocol	https://link.springer.com/article/10.1007/s00540-021-02900-4
Publication of results	Published

Result
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

Progress
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
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.

Management information
Registered date	2020 Year 06 Month 27 Day
Last modified on	2022 Year 01 Month 08 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000046721