A trial comparing central venous catheter (CVC) and peripherally inserted central venous catheter (PICC) line central venous catheter
| ISRCTN | ISRCTN70648637 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN70648637 |
| Secondary identifying numbers | N/A |
- Submission date
- 13/03/2013
- Registration date
- 16/05/2013
- Last edited
- 22/02/2019
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Other
Plain English summary of protocol
Background and study aims
This study aims to compare two kinds of catheters (thin tubes inserted into the body for treatment or surgery): a central venous catheter (CVC) and peripherally inserted central venous catheter (PICC) which is inserted in a vein in the arm instead of a vein in the neck or chest.
Who can participate?
Both male and female patients, who are over 18 years of age, in need of a central venous catheter, who have received information on the study and have given the consent for this study.
What does the study involve?
In-patients and out-patients who are referred to the department for gastrointestinal cancer treatment in Sahlgrenska University Hospital (Sweden).
What are the possible benefits and risks of participating?
There are no known risks. The treatment with these catheters is well documented and well known.
Where is the study run from?
Sahlgrenska University Hospital, Gothenburg, Sweden
When is the study starting and how long is it expected to run for?
The study takes place between January 2013 and December 2015.
Who is funding the study?
Scholarships
Who is the main contact?
Dr Cecilia Engström
cecilia.engstrom@surgery.gu.se
Contact information
Scientific
Sahlgrensk University Hostpital/SS
Goteborg
41345
Sweden
| cecilia.engstrom@surgery.gu.se |
Study information
| Study design | Randomised clinical trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | Randomised clinical trial on venous access comparing central venous catheter and peripher inserted central venous catheter |
| Study acronym | CVC, PICC |
| Study objectives | PICC line use is more safe, with less side-effects and adverse events and perhaps also less expensive and easier to use both for patients and medical personal. |
| Ethics approval(s) | Board of Ethics in Goteborg, 2011-09-11, ref: Dnr 492-11 |
| Health condition(s) or problem(s) studied | Upper GI disease |
| Intervention | Patients are enrolled as indoor and outdoor patients and randomised in a way approved before and after patients consent. The specific catheter is inserted by either a specialised nurse or doctor. Arm 1: CVC treatment Arm 2: PICC line |
| Intervention type | Other |
| Primary outcome measure | Catheter treatment period: measured in 2014/15 approximately |
| Secondary outcome measures | Side effects such as thrombosis, thromophlebitis, pneumothorax, hemothorax, deep and surface infections: measured in 2014/15 approximately |
| Overall study start date | 01/01/2013 |
| Completion date | 31/12/2015 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | Approximately 250 patients |
| Key inclusion criteria | 1. Male or Female over 18 yrs in need of a central line 2. Patient has received information of the study and consent is given |
| Key exclusion criteria | Patient who has no need of central venous access |
| Date of first enrolment | 01/01/2013 |
| Date of final enrolment | 31/12/2015 |
Locations
Countries of recruitment
- Sweden
Study participating centre
41345
Sweden
Sponsor information
Hospital/treatment centre
Sahlgrenska University Hospital/SS
Goteborg
41345
Sweden
| cecilia.engstrom@surgery.gu.se | |
"ROR" |
https://ror.org/04vgqjj36 |
Funders
Funder type
University/education
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration 2017 poster presented at Euroanaesthesia 2017 https://www.morressier.com/article/comparison-peripherally-inserted-central-venous-catheter-picc-versus-central-venous-catheter-cvc--consecutive-selection-study/58f5b033d462b80296c9ddb8 |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Abstract results | results presented at Euroanaesthesia | 03/06/2017 | No | No |
Editorial Notes
22/02/2019: The following changes have been made:
1. Publication reference added.
2. Conference poster link added to publication and dissemination plan.
