UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000025080
Receipt number R000028576
Scientific Title Novel preparation method of intravenous infusion therapy of treprostinil in pulmonary arterial hypertension
Date of disclosure of the study information 2016/11/30
Last modified on 2017/08/28 18:32:19

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Basic information

Public title

Novel preparation method of intravenous infusion therapy of treprostinil in pulmonary arterial hypertension

Acronym

Novel preparation method of intravenous infusion therapy of treprostinil in PAH

Scientific Title

Novel preparation method of intravenous infusion therapy of treprostinil in pulmonary arterial hypertension

Scientific Title:Acronym

Novel preparation method of intravenous infusion therapy of treprostinil in PAH

Region

Japan


Condition

Condition

pulmonary arterial hypertension

Classification by specialty

Cardiology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Using glucose,compare work time and work process of Standard method(S) and New method(N) which is treprostinil preparation method.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Adjustment time, adjustment error due to difference in preparation method

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Cross-over

Randomization

Randomized

Randomization unit

Individual

Blinding

Single blind -participants are blinded

Control

Placebo

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Educational,Counseling,Training

Type of intervention

Maneuver

Interventions/Control_1

Perform two different procedures

Interventions/Control_2

Perform two different procedures

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

60 years-old >

Gender

Male and Female

Key inclusion criteria

2nursing nurses with clinical experience.
Nursing student aged20years and over and taking all injection lectures.
When participating in this research, after having received sufficient explanation, those who fully understand the contents of the research and obtained document consent by the target person's free will

Key exclusion criteria

Nurse undergoing work restrictions.
Lecture on injection technique Students who have not taken exercise.

Target sample size

30


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Sachiko Igawa

Organization

Nagasaki University Hospital

Division name

Nursing department

Zip code


Address

1-7-1 Sakamoto Nagasaki City

TEL

095-819-7468

Email

igasachi@nagasaki-u.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Sachiko Igawa

Organization

Nagasaki University Hospital

Division name

Outpatient department (2nd floor)

Zip code


Address

1-7-1 Sakamoto Nagasaki City

TEL

095-819-7468

Homepage URL


Email

igasachi@nagasaki-u.ac.jp


Sponsor or person

Institute

Nagasaki University Hospital Nursing department

Institute

Department

Personal name



Funding Source

Organization

Nagasaki University Hospital

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


Address


Tel


Email



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

2016 Year 11 Month 30 Day


Related information

URL releasing protocol


Publication of results

Published


Result

URL related to results and publications


Number of participants that the trial has enrolled


Results

METHODS: The survey was conducted on two groups of nurses and students. The target was the name.30 nurse workers (average age 37.0 years old) with university hospital clinical experience of 1 year or more who conducts the injection procedure on a daily basis, 21students (average age 21.2 years old) who took lectures on injection at the nursing college To prepare the diluent, physiological saline was used as a solvent, and a 5% dextrose solution was substituted for Treprostinil injection solution. For the survey, diluent preparation was carried out 5 times for S method and N dilution preparation respectively, and the preparation time for each test was measured. As a diluent concentration measurement, a blood sugar measuring device was used. Evaluation items were "dispersion of concentration of diluent", "time required for preparation", "degree of difficulty of preparation" of each nurse / student.
RESULTS: There were no significant differences in dilution concentration between nurses and students, but there was a tendency for variation to be large for nursing practitioner N law and student S law. The total time taken for 5 preparations was short for both nurses and students (p <0.001), and preparation difficulty was easy for both nurses and students (p <0.001).
Conclusion: The method N is simple and easy to prepare in a short time without any problems in the preparation of the diluent, and it can be proposed as one of the methods for preparing the treprostinil diluent by the patient himself.

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

Completed

Date of protocol fixation

2016 Year 09 Month 15 Day

Date of IRB


Anticipated trial start date

2016 Year 11 Month 01 Day

Last follow-up date

2017 Year 02 Month 10 Day

Date of closure to data entry

2017 Year 02 Month 15 Day

Date trial data considered complete

2017 Year 03 Month 16 Day

Date analysis concluded

2017 Year 03 Month 16 Day


Other

Other related information



Management information

Registered date

2016 Year 11 Month 30 Day

Last modified on

2017 Year 08 Month 28 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028576


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name