Continuous Ambulatory Peritoneal Dialysis, End Stage Renal Disease
Conditions
Brief summary
Phase IV post-marketing study to evaluate the effect of Extraneal on the HOMA index in non-diabetic CAPD patients over the long-dwell exchange. The purpose of the study is to investigate if the use of Extraneal (which is a mixture of high weight glucose polymers), instead of glucose-based solutions such as Dianeal is going to lower the HOMA index in non-diabetic CAPD patients.
Interventions
PROCEDUREBlood samples
Samples taken monthly
PROCEDUREMeasure of peritoneal ultrafiltrates
Measured by the investigators intermittently and by the patients themselves on a monthly basis
Sponsors
Baxter Healthcare Corporation
Vantive Health LLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* must be over 18-years old and under 75-years old * Peritoneal Equilibration Test (PET) result of high, high average or low average transport * non-diabetic patient * be in Continuous Ambulatory Peritoneal Dialysis (CAPD) * prevalent patients that have been in peritoneal dialysis at least 30 days * wish to participate
Exclusion criteria
* Have a Charlson score of \>7 and have a life expectancy of less than 12 months * HIV positive * present with peritonitis in the month prior to randomisation * present with cardiovascular, metabolic or infection complications that have required hospitalisation in the month prior to the randomisation * have active cancer * pregnant women * patients with known allergy to starch-based polymer * patients who have a significant psychiatric disorder or mental disability that could interfere with the patient´s ability to provide Informed Consent and comply with the protocol procedures * women incapable of maintaining an effective and accepted contraception method
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| HOMA index | 4 months | Measure the changes in the levels of the HOMA index when Extraneal (7.5%) is being administered in the long-dwell exchange and compare these levels to the HOMA index resulting when using Dianeal 2.5% in the long-dwell exchange in non-diabetic CAPD patients. This outcome will be evaluated by measurements taken monthly over a period of 4 months. |
Secondary
| Measure | Time frame |
|---|---|
| Ultrafiltration of long-dwell exchange | 12 months |
| Blood pressure | 12 months |
| Quality of life | 12 months |
| HbA1c | 12 months |
| Time during hospitalization | 12 months |
| Incidence of Adverse Events | 12 months |
| Hospitalization rate | 12 months |
Countries
Colombia
Outcome results
None listed