UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000061285 |
|---|---|
| Receipt number | R000068857 |
| Scientific Title | Effectiveness of Warm Infusion Fluids in Preventing Complications During Peripheral Venous Catheter Cannulation |
| Date of disclosure of the study information | 2026/04/20 |
| Last modified on | 2026/04/17 11:25:44 |
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Basic information
Public title
Effectiveness of Warm Infusion Fluids in Preventing Complications During Peripheral Venous Catheter Cannulation
Acronym
Warm-IV Study
Scientific Title
Effectiveness of Warm Infusion Fluids in Preventing Complications During Peripheral Venous Catheter Cannulation
Scientific Title:Acronym
Warm-IV Study
Region
| Japan |
Condition
Condition
Peripheral intravenous catheter related complications and associated issues
Classification by specialty
| Nursing |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We focused on exploring the effectiveness of warm infusion fluids in preventing complications during peripheral venous catheter cannulation.
Basic objectives2
Others
Basic objectives -Others
The study objectives are as follows:
1.Compared with the administration of room temperature intravenous fluids, do warmed intravenous fluids induce vasodilation? If so, does this effect persist, and does it improve the catheter to vessel ratio?
2.Compared with room temperature intravenous fluids, how does the temperature of the tissues surrounding the cannulated vein change during the administration of warmed intravenous fluids?
3.Compared with the administration of room temperature intravenous fluids, are there any changes in subjective symptoms during the administration of warmed intravenous fluids?
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Vascular diameter (5, 15, and 30 minutes after administration)
Key secondary outcomes
Temperature distribution around cannulated blood vessels and subjective reports (e.g. sensation of coolness, pain or heaviness in the arm).
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Other |
Interventions/Control_1
Intervention 1, Number of procedures 1
After 15 minutes of bed rest, administer 200 ml of Solita T3 maintenance infusion solution stored at 25 degree Celsius in a cool incubator at a rate of 60 ml/h for 30 minutes.
Interventions/Control_2
Intervention 2, Number of procedures 1
After 15 minutes of bed rest, administer 200 mL of Solita T3 maintenance infusion warmed to 39 degree Celsius using an automatic warmer at a rate of 60 mL/h for 30 minutes.
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
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Healthcare professionals aged 65 or under, in good health, who have agreed to participate in the study.
Key exclusion criteria
Individuals currently experiencing any illness, regardless of whether they are receiving medication; those who have had an illness within the past month; and those with a history of malignant neoplasms, heart disease, kidney disease, endocrine disorders, metabolic disorders, neurological disorders, or other conditions who have been deemed unsuitable by a physician.
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Motoko |
| Middle name | |
| Last name | Kitada |
Organization
Josai International University
Division name
Faculty of Health Sciences
Zip code
283-8555
Address
1 Gumyo, Togane, Chiba
TEL
0475557046
mhorii@jiu.ac.jp
Public contact
Name of contact person
| 1st name | Motoko |
| Middle name | |
| Last name | Kitada |
Organization
Josai International University
Division name
Faculty of Health Sciences
Zip code
283-8555
Address
1 Gumyo, Togane, Chiba
TEL
0475-55-7046
Homepage URL
mhorii@jiu.ac.jp
Sponsor or person
Institute
Josai International University
Institute
Department
Personal name
Motoko Kitada
Funding Source
Organization
Japan Society for the Promotion of Science (JSPS)
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
Josai International University Committee for Medical and Life Science Research on Human Subjects
Address
1 Gumyo, Togane, Chiba
Tel
0475-55-7832
research-c@jiu.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
| 2026 | Year | 04 | Month | 20 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Preinitiation
Date of protocol fixation
| 2026 | Year | 06 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2029 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2026 | Year | 04 | Month | 17 | Day |
Last modified on
| 2026 | Year | 04 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068857
