Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
1443
Study information
Scientific title
Acronym
Study hypothesis
Evaluate patient satisfaction in a first filed utilisation before final desicion on product design.
Ethics approval
Ethics Committee at San Marino University Hospital in Genova , approved on 19/07/2006, ref: 0037753/06
Study design
Open, controlled, single center, comparative prospective pilot study
Primary study design
Interventional
Secondary study design
Non randomised controlled trial
Trial setting
Hospitals
Trial type
Quality of life
Patient information sheet
Condition
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
Phase
Not Specified
Drug names
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 trial start date
22/01/2007
Overall trial end date
10/03/2007
Reason abandoned (if study stopped)
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Not Specified
Target number of participants
5
Participant 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
Recruitment start date
22/01/2007
Recruitment end date
10/03/2007
Locations
Countries of recruitment
Italy
Trial participating centre
Gambro
Mölndal
SE-431 37
Sweden
Sponsor information
Organisation
Gambro (Sweden)
Sponsor details
Clinical Affairs
Emdalavägen 5
P.O. Box 10101
Lund
SE 220 10
Sweden
Sponsor type
Industry
Website
Funders
Funder type
Industry
Funder name
Gambro (Sweden)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list