Evaluating comfort and handling of new patient extension line and bag connector for Peritoneal Dialysis (PD). A short-term, open controlled study.
ISRCTN | ISRCTN03187943 |
---|---|
DOI | https://doi.org/10.1186/ISRCTN03187943 |
Secondary identifying numbers | 1443 |
- Submission date
- 11/01/2007
- Registration date
- 25/01/2007
- Last edited
- 25/01/2007
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Urological and Genital Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Mrs Christina Schönborg
Scientific
Scientific
Gambro
Clinical Affairs
Krokslätts Fabriker 32
Mölndal
SE-431 37
Sweden
Study information
Study design | Open, controlled, single center, comparative prospective pilot study |
---|---|
Primary study design | Interventional |
Secondary study design | Non randomised controlled trial |
Study setting(s) | Hospital |
Study type | Quality of life |
Scientific title | |
Study objectives | Evaluate patient satisfaction in a first filed utilisation before final desicion on product design. |
Ethics approval(s) | Ethics Committee at San Marino University Hospital in Genova , approved on 19/07/2006, ref: 0037753/06 |
Health condition(s) or problem(s) studied | ESRD - End Stage Renal Disease |
Intervention | Tested products: twist extension line combined with twist female connector on Gambrosol trio. Reference products: current patient line (PDL 1201-8) and current Gambro CAPD system. All patients will be treated in a CAPD program exchangning Gambrosol trio GEM 20U03 Ca 2,5 with twist for 3 to 5 exchanges/day following their physician's prescription on glucose concentration to be used. Evaluation on patient satisfaction will be done with a questionnaire at three times: before switch to twist, after two weeks on twist and at four weeks on tested products (end of study). |
Intervention type | Other |
Primary outcome measure | Patient satisfaction on handling by comparing current system with new system, twist. |
Secondary outcome measures | Collect safety data on new patient line. |
Overall study start date | 22/01/2007 |
Completion date | 10/03/2007 |
Eligibility
Participant type(s) | Patient |
---|---|
Age group | Adult |
Lower age limit | 18 Years |
Sex | Not Specified |
Target number of participants | 5 |
Key inclusion criteria | 1. Patients suffering from chronic renal failure 2. Age 18 years or older 3. Treated in a Continuous Ambulatory Peritoneal Dialysis (CAPD) program with Gambrosol trio (GEM 20U03 Ca 2,5) 4. Treated on CAPD for at least 24 months 5. Signed written informed consent to participate in the study |
Key exclusion criteria | 1. Pregnancy 2. HIV 3. Hepatitis 4. Participation in other studies during the study period if considered to cause interference with either of the studies 5. Treated in a haemodialysis program, patients with diagnosed abdominal pain not related with PD solution 6. Patients on night Automated Peritoneal Dialysis (APD) 7. Peritonitis within one month prior to the study 8. Presence of exit-site/tunnel infection or ongoing peritonitis 9. Impaired and /or disabled patients |
Date of first enrolment | 22/01/2007 |
Date of final enrolment | 10/03/2007 |
Locations
Countries of recruitment
- Italy
- Sweden
Study participating centre
Gambro
Mölndal
SE-431 37
Sweden
SE-431 37
Sweden
Sponsor information
Gambro (Sweden)
Industry
Industry
Clinical Affairs
Emdalavägen 5
P.O. Box 10101
Lund
SE 220 10
Sweden
Website | http://www.gambro.com/start.aspx?id=752 |
---|---|
https://ror.org/05mw5ed57 |
Funders
Funder type
Industry
Gambro (Sweden)
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 |
IPD sharing plan |