Inflammation, Nutrition, Peritoneal Dialysis
Conditions
Brief summary
Patients with end stage renal disease (ESRD) who use peritoneal dialyses with Physioneal(R) (Baxter A/S, Denmark) were allocated to inject either placebo or tinzaparin daily into the morning dialysis bag. Active medication, as well as placebo, was added for three months separated by a one month washout period. At the beginning and end of each treatment period peritoneal equilibrations tests (PE-tests), Kt/V, blood and dialysate samples were analyzed. We, the researchers at Ribe County Hospital, set out to examine inflammation (local and systemic), nutrition and ultrafiltration.
Interventions
DRUGtinzaparin
Sponsors
LEO Pharma
Coloplast A/S
Ribe County Hospital
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* End stage renal disease * Peritoneal dialysis without complication for minimum of three months * 18 years or above * Informed consent
Exclusion criteria
* Known coagulatory defects including anticoagulation therapy * Known bleeding tendency * Peritonitis within two months prior to inclusion * Pregnancy * Breast feeding * Active infection * Non-informed consent * Allergy to heparin or prior heparin induced thrombocytopenia
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Grade of inflammation, local and systemic | — |
Secondary
| Measure | Time frame |
|---|---|
| Vascular compliance | — |
| Nutritional state | — |
| Efficacy of Peritoneal Dialysis | — |
| Change in local cellular distribution | — |
| Change in local and systemic generation of thrombi | — |
Countries
Denmark
Outcome results
None listed