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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Samples taken monthly
Measured by the investigators intermittently and by the patients themselves on a monthly basis
Unnamed facility
Bogotá, Colombia
HOMA index
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.
Time frame: 4 months
HbA1c
Time frame: 12 months
Ultrafiltration of long-dwell exchange
Time frame: 12 months
Blood pressure
Time frame: 12 months
Quality of life
Time frame: 12 months
Hospitalization rate
Time frame: 12 months
Time during hospitalization
Time frame: 12 months
Incidence of Adverse Events
Time frame: 12 months
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