Evaluating comfort and handling of new patient extension line and bag connector for Peritoneal Dialysis (PD). A short-term, open controlled study.

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

Mrs Christina Schönborg
Scientific

Gambro
Clinical Affairs
Krokslätts Fabriker 32
Mölndal
SE-431 37
Sweden

Primary study design	Interventional
Study design	Open, controlled, single center, comparative prospective pilot study
Secondary study design	Non randomised controlled trial
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(s)	Patient satisfaction on handling by comparing current system with new system, twist.
Key secondary outcome measure(s)	Collect safety data on new patient line.
Completion date	10/03/2007

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Not Specified
Target sample size at registration	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

Gambro

Mölndal
SE-431 37
Sweden

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan