MesoHep II: Intraperitoneal Low Molecular Weight Heparin in Peritoneal Dialysis

Ribe County Hospital36 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Masking

DOUBLE

Enrollment

Conditions

Inflammation Nutrition Peritoneal Dialysis

Interventions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Grade of inflammation, local and systemic

Secondary Outcomes

Vascular compliance

Nutritional state

Efficacy of Peritoneal Dialysis

Change in local cellular distribution

Change in local and systemic generation of thrombi