AzTrials
AzTrials

IV InjectionNCT04523259

Compatibility Problems and Prescribing Pattern of Injectable Drugs at the Hospital

An observational study of IV Injection, run by National Taiwan University Hospital.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

Drug safety is always a national, as well as international, patient safety goal. Administration of injection, especially intravenous infusion, is an extremely complicated and dangerous process, which includes reconstitution, dilution, selection of diluent and volume, verification of concentration of final solution… Read more about this study

Who is it for?
Ages 20 to 65 yearsHealthy volunteers can take part
Conditions the study is for
IV Injection
How many people
127 participants
Where
No sites listed yet
Study dates
9 Nov 2009to 4 Nov 2013
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 to 65 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Study population: nurse in ICU

Who may be able to join

  • nurses

Who cannot join

  • not nurses

About this study

Drug safety is always a national, as well as international, patient safety goal. Administration of injection, especially intravenous infusion, is an extremely complicated and dangerous process, which includes reconstitution, dilution, selection of diluent and volume, verification of concentration of final solution, check for stability, sterility and compatibilities, and the selection of intravenous (IV) set, peripheral or central route, and the rate of infusion. Due to its inherent complexity, errors occur easily during these procedures. Literatures indicated that the incidence of injection administration errors ranged from 13% to 84%, which included errors in dosage, diluents, and volumes; excessive administration rate; and incompatible IV admixture.

In the U.S.A., pharmacists provide comprehensive clinical services. They ensure the appropriateness of every step in the process from prescription and dosage verification, drug reconstitution and dilution, selection of diluents and concentration, to the rate of administration. Even more, they provide the final IV products that are ready to administer to the patients (IV admixture services). Therefore, many common administration errors can be avoided. In Taiwan, nevertheless, pharmacists have limited role in IV services due to our health-care system. There are no studies on the administration pattern of injections. There is still room for improvement in the assurance of injection safety.

Read more

To ensure the safety of injection, we not only have to oversee the accuracy of drugs and dosage, but also take the compatibilities among drugs and diluents seriously.

Because diluent is not a mandatory claim data, the National Health Insurance data base cannot provide the related information for drug compatibility epidemiology study. The application for reimbursement of injections is based on total amount used instead of daily usage; it is therefore difficult to find drug incompatibility problems in this data base. Hospital data base analysis, questionnaire survey and chart review are more feasible for such study.

This study will analyze the prescriptions of IV injection in the intensive-care units and pediatric units to determine the prescribing pattern. High risk IV admixtures and Y-site administrations will be explored by questionnaire survey and literature review. Laboratory experiments will be done on some indicator drugs to find the reasons, categories and severities of the compatibilities. A list of incompatible drugs shall be generated for computerized intervention. We hope the results of the study can be used as a reference for guideline, policy and procedure for health care system and government.

Conditions
IV Injection
Keywords
Drug incompatibility; injections; infusion, intravenous; medication errors

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Drug incompatibility assessed by questionnaire survey

    IV admixture

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Aug 2020
  2. Study start9 Nov 2009
  3. Primary completion1 Jul 2010
  4. Study completion4 Nov 2013

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Retrospective
Enrolment
127 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04523259
Sponsor's protocol ID
200911016R
Status last verified
Aug 2020
First submitted
19 Aug 2020
Last updated
21 Aug 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

An observational study of IV Injection, run by National Taiwan University Hospital.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Drug incompatibility assessed by questionnaire survey (time frame: 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Aug 2020.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in