UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016210 |
|---|---|
| Receipt number | R000018809 |
| Scientific Title | Relationship between slow gait speed and post-operative delirium in elderly patients |
| Date of disclosure of the study information | 2015/01/15 |
| Last modified on | 2021/06/23 08:44:04 |
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Basic information
Public title
Relationship between slow gait speed and post-operative delirium in elderly patients
Acronym
Slow gait speed and post-operative delirium
Scientific Title
Relationship between slow gait speed and post-operative delirium in elderly patients
Scientific Title:Acronym
Slow gait speed and post-operative delirium
Region
| Japan |
Condition
Condition
Urological disease
Classification by specialty
| Urology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To assess whether or not gait parameters in elderly patient is useful tool for prediction of post-operative delirium
Basic objectives2
Others
Basic objectives -Others
Non-interventional trial; evaluation of optimal cut-off value
Trial characteristics_1
Exploratory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
postoperative delirium
Key secondary outcomes
Calculating the cu-off value for postoperative delirium, evaluation of risk factors for postoperative delirium
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
| 20 | years-old | < |
Age-upper limit
| 95 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients who undergo urological surgery
Key exclusion criteria
Patients with walking difficulty, and difficulties in giving fully informed consent
Target sample size
500
Research contact person
Name of lead principal investigator
| 1st name | Shingo |
| Middle name | |
| Last name | Hatakeyama |
Organization
Hirosaki University, Graduate School of Med
Division name
Urology
Zip code
0368562
Address
53 Hontyou, Hirosaki
TEL
0172-39-5091
shingorilla2@gmail.com
Public contact
Name of contact person
| 1st name | Shingo |
| Middle name | |
| Last name | Hatakeyama |
Organization
Hirosaki University, Graduate School of Med
Division name
Urology
Zip code
0368562
Address
53 Hontyou, Hirosaki
TEL
0172-39-5091
Homepage URL
shingorilla2@gmail.com
Sponsor or person
Institute
Hirosaki University, Graduate School of Med
Institute
Department
Personal name
Funding Source
Organization
apan Society for the Promotion of Science
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Hirosaki Universicy IRB
Address
5 Zaifu-chou
Tel
0172395091
rinri@hirosaki-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 | 01 | Month | 15 | Day |
Related information
URL releasing protocol
http://journals.plos.org/plosone/article?id=10.1371%2Fjournal.pone.0153961
Publication of results
Published
Result
URL related to results and publications
http://journals.plos.org/plosone/article?id=10.1371%2Fjournal.pone.0153961
Number of participants that the trial has enrolled
215
Results
Ten patients (4.7%) experienced postoperative delirium. These patients were significantly older, had weak handgrip strength, a higher fall risk assessment score, slow gait speed, and greater renal function decline compared with patients without delirium. Multivariate analysis revealed slow gait speed (>13.0 s) and rapid renal function decline (>30%) were independent risk factors for postoperative delirium.
Results date posted
| 2021 | Year | 06 | Month | 23 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
The median age of this cohort was 67 years.
Participant flow
We prospectively evaluated pre- and postoperative risk factors for postoperative delirium in consecutive 215 patients who received urological surgery between August 2013 and November 2014. Preoperative factors included patient demographics, comorbidities, and frailty assessment. Frailty was measured by handgrip strength, fatigue scale of depression, fall risk assessment, and gait speed (the timed Get-up and Go test). Postoperative factors included types of anesthesia, surgical procedure, renal function and serum albumin decline, blood loss, surgery time, highest body temperature, and complications.
Adverse events
None
Outcome measures
Uni- and multivariate logistic regression analyses were performed to assess pre- and postoperative predictors for the development of postoperative delirium.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2013 | Year | 08 | Month | 19 | Day |
Date of IRB
| 2017 | Year | 01 | Month | 06 | Day |
Anticipated trial start date
| 2017 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
| 2019 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2019 | Year | 03 | Month | 31 | Day |
Other
Other related information
Prospective, single-arm study
Management information
Registered date
| 2015 | Year | 01 | Month | 14 | Day |
Last modified on
| 2021 | Year | 06 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018809
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