UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040917 |
|---|---|
| Receipt number | R000046721 |
| Scientific Title | Characteristics, treatment, and outcomes of postoperative patients who required rapid response system intervention: A nationwide database analysis |
| Date of disclosure of the study information | 2020/06/27 |
| Last modified on | 2022/01/08 16:40:56 |
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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
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
sentoy@med.nagoya-cu.ac.jp
Sponsor or person
Institute
Department of Anesthesiology and Intensive Care Medicine, Nagoya City University Graduate School of Medical Sciences
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046721
