UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039042 |
|---|---|
| Receipt number | R000044435 |
| Scientific Title | The suppressive effect of shivering during targeted temperature management with skin counter warming limited to extremities |
| Date of disclosure of the study information | 2020/01/06 |
| Last modified on | 2025/02/11 06:19:34 |
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Basic information
Public title
The suppressive effect of shivering during targeted temperature management with skin counter warming limited to extremities
Acronym
The suppressive effect of shivering during targeted temperature management with skin counter warming limited to extremities
Scientific Title
The suppressive effect of shivering during targeted temperature management with skin counter warming limited to extremities
Scientific Title:Acronym
The suppressive effect of shivering during targeted temperature management with skin counter warming limited to extremities
Region
| Japan |
Condition
Condition
Patients after cardiac arrest, traumatic brain injury or cerebrovascular accident
Classification by specialty
| Emergency medicine | Intensive care medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The efficacy of skin counter warming limited to extremities for shivering during targeted temperature management
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The frequency and the degree of shivering during targeted temperature management
Key secondary outcomes
The change of Bedside Shivering Assessment Scale every hour
The dosage of sedatives, analgesics and neuromuscular blockers
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Warming blankets were put on all of eligible patients after the ICU admission. The following interventions continue until finishing targeted temperature management.
Group A: inflating the blanket with air heated to 43 degrees Celsius
Interventions/Control_2
Group B: inflating the blanket with room-temperature air
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients undergoing targeted temperature management with ECMO or intravascular cooling device
Key exclusion criteria
Under 18 year old
Patients who do not get consent or withdraw consent
Patients who are out of drug administration protocol
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Eichi |
| Middle name | |
| Last name | Narimatsu |
Organization
Sapporo medical university
Division name
Emergency medicine
Zip code
0608543
Address
291 South 1 West 16, Chuo-Ku, Sapporo, Hokkaido, Japan
TEL
011-611-2111
enarimat@sapmed.ac.jp
Public contact
Name of contact person
| 1st name | Ryuichiro |
| Middle name | |
| Last name | Kakizaki |
Organization
Sapporo medical university
Division name
Emergency medicine
Zip code
0608543
Address
291 South 1 West 16, Chuo-Ku, Sapporo, Hokkaido, Japan
TEL
011-611-2111
Homepage URL
r.kakizaki@sapmed.ac.jp
Sponsor or person
Institute
Sapporo medical university
Div. of Emergency medicine
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Sapporo medical university
Address
291 South 1 West 16, Chuo-Ku, Sapporo, Hokkaido, Japan
Tel
011-611-2111
r.kakizaki@sapmed.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
札幌医科大学附属病院高度救命救急センター
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 01 | Month | 06 | Day |
Related information
URL releasing protocol
https://www.jstage.jst.go.jp/article/jsicm/31/6/31_31_575/_article/-char/ja
Publication of results
Published
Result
URL related to results and publications
https://www.jstage.jst.go.jp/article/jsicm/31/6/31_31_575/_article/-char/ja
Number of participants that the trial has enrolled
43
Results
Thirty-nine patients were included in the analysis (20 and 19 in SCW and non-SCW group, respectively). Skin temperature at all extremities was significantly increased 8 hours after initiation of SCW; however, no differences were observed in the number of shivering for 24 hours after initiating SCW. Moreover, there was no change in the number of shivering and the Bedside Shivering Assessment Scale for every 8 hours, and in total 24-hour doses of sedatives and opioid in both groups.
Results date posted
| 2025 | Year | 02 | Month | 11 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Patients aged 18 years or older who underwent targeted temperature management using extracorporeal membrane oxygenation or an intravascular cooling device due to post-cardiac arrest syndrome or severe brain injury between January 2020 and March 2022.
Participant flow
After the eligible patients were identified, informed consent was obtained from their relatives, and they were randomly assigned to two groups.
Adverse events
None.
Outcome measures
The number of shivering for 24 hours after initiating skin counter warming.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2019 | Year | 12 | Month | 12 | Day |
Date of IRB
| 2019 | Year | 12 | Month | 12 | Day |
Anticipated trial start date
| 2020 | Year | 01 | Month | 20 | Day |
Last follow-up date
| 2022 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2022 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2022 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2022 | Year | 10 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2020 | Year | 01 | Month | 02 | Day |
Last modified on
| 2025 | Year | 02 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044435
