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

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

Study information

Study designOpen, controlled, single center, comparative prospective pilot study
Primary study designInterventional
Secondary study designNon randomised controlled trial
Study setting(s)Hospital
Study typeQuality of life
Scientific title
Study objectivesEvaluate 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) studiedESRD - End Stage Renal Disease
InterventionTested 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 typeOther
Primary outcome measurePatient satisfaction on handling by comparing current system with new system, twist.
Secondary outcome measuresCollect safety data on new patient line.
Overall study start date22/01/2007
Completion date10/03/2007

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexNot Specified
Target number of participants5
Key inclusion criteria1. 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 criteria1. 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 enrolment22/01/2007
Date of final enrolment10/03/2007

Locations

Countries of recruitment

  • Italy
  • Sweden

Study participating centre

Gambro
Mölndal
SE-431 37
Sweden

Sponsor information

Gambro (Sweden)
Industry

Clinical Affairs
Emdalavägen 5
P.O. Box 10101
Lund
SE 220 10
Sweden

Website http://www.gambro.com/start.aspx?id=752
ROR logo "ROR" 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 shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan