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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01548365
Other study ID # ITNE01
Secondary ID
Status Completed
Phase N/A
First received March 5, 2012
Last updated September 20, 2013
Start date March 2012
Est. completion date December 2012

Study information

Verified date September 2013
Source Basque Health Service
Contact n/a
Is FDA regulated No
Health authority Spain: Ethics Committee
Study type Interventional

Clinical Trial Summary

The purpose of this study is to determine whether an infusion therapy nursing expert service is effective in decreasing hospital length of stay, improving the clinical results of venous access devices and increasing patient satisfaction with venous access.


Recruitment information / eligibility

Status Completed
Enrollment 82
Est. completion date December 2012
Est. primary completion date September 2012
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Require an estimated long prescription of intravenous treatment. These treatments may be of fluid therapy, pharmacological, nutritional or hemotherapy.

- Estimation of 7 days or more of continuous intravenous therapy.

- Estimation of an intermittent intravenous therapy of less than a week, but on a monthly basis or less and a total estimated duration superior to 3 months.

- Be patient at Araba University Hospital

Exclusion Criteria:

- To have a central venous catheter indwelled

- MRSA (Methicillin Resistant Staphylococcus Aureus)

- Younger than 18 years old

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Health Services Research


Related Conditions & MeSH terms

  • Patients With Prolonged Intravenous Therapy

Intervention

Other:
Infusion therapy nursing expert service
The ITNE will assess the patient and treatment characteristics and use an evidence based decision making algorithm for the selection of the most suitable VAD. If the VAD needed is a PICC or a midline ITNE will place it following hospital's protocols. If needed, ITNE will also educate and support patients and next of keens in the maintenance of the device at home. If other devices such as peripheral catheters, central venous catheters (jugular or subclavian) or venous subcutaneous reservoirs are the preferable VADs for patients and treatment conditions, ITNE will work together with health professionals in charge of patients to activate the usual procedures to place the according device.

Locations

Country Name City State
Spain Araba University Hospital Vitoria-Gasteiz Araba

Sponsors (2)

Lead Sponsor Collaborator
Basque Health Service KRONIKGUNE Cronicity Research Centre

Country where clinical trial is conducted

Spain, 

Outcome

Type Measure Description Time frame Safety issue
Primary Hospital Length of Stay 3 months Yes
Secondary Venous Access Devices reaching end of treatment 3 months Yes
Secondary Incidence of complications derived from VAD 3 months Yes
Secondary Patients receiving intravenous therapy at home 3 months Yes
Secondary Patient satisfaction with VAD 3 months No