MesoHep II: Intraperitoneal Low Molecular Weight Heparin in Peritoneal Dialysis

Sponsor

Ribe County Hospital (Other)

Overall Status

Terminated

CT.gov ID

NCT00135863

Collaborator

LEO Pharma (Industry), Coloplast A/S (Industry)

Enrollment

Location

Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Inflammation Nutrition Peritoneal Dialysis	Drug: tinzaparin	N/A

Study Design

Study Type:

Interventional

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

Double

Official Title:

Intraperitoneal Low Molecular Weight Heparin in Peritoneal Dialysis

Study Start Date :

May 1, 2004

Study Completion Date :

May 1, 2005

Outcome Measures

Primary Outcome Measures

Grade of inflammation, local and systemic []

Secondary Outcome Measures

Vascular compliance []
Nutritional state []
Efficacy of Peritoneal Dialysis []
Change in local cellular distribution []
Change in local and systemic generation of thrombi []

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Ribe County Hospital	Esbjerg	Ribe	Denmark	DK-6700

Sponsors and Collaborators

Ribe County Hospital
LEO Pharma
Coloplast A/S

Investigators

Study Chair: Robert S Petersen, MD, Ribe County Hospital, Department of Nephrology
Principal Investigator: Mikkel B Rasmussen, MD, Ribe County Hospital, Department of Nephrology