MesoHep II: Intraperitoneal Low Molecular Weight Heparin in Peritoneal Dialysis
Not Applicable
Terminated
- Conditions
- Peritoneal DialysisNutritionInflammation
- Registration Number
- NCT00135863
- Lead Sponsor
- Ribe County Hospital
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 36
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Primary Outcome Measures
Name Time Method Grade of inflammation, local and systemic
- Secondary Outcome Measures
Name Time Method Vascular compliance Change in local cellular distribution Change in local and systemic generation of thrombi Nutritional state Efficacy of Peritoneal Dialysis
Trial Locations
- Locations (1)
Ribe County Hospital
🇩🇰Esbjerg, Ribe, Denmark