Removal of Protein Bound Uremic Toxins by Modified Plasma Separation and Adsorption Combined With Hemodialysis

• Sponsor: Rigshospitalet, Denmark (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT00375635
• Collaborator: (none)
• Enrollment: 10
• Location: 1
• Duration (Months): 7
• Patients Per Site Per Month: 1.4

Study Details

Study Description

Brief Summary

The aim of this study is to examine removal of protein bound uremic substances by mFPSA in chronic hemodialysis patients. mFPSA is an extracorporal blood purification system developed for detoxification in acute liver failure by removal of protein bound as well as water soluble substances.

Condition or Disease	Intervention/Treatment	Phase
Uremia	Procedure: mFPSA treatment	N/A

Detailed Description

Measurements of uremic protein bound substances before and after mFPSA and a preceding routine hemodialysis session.

Study Design

• Study Type: Interventional
• Allocation: Non-Randomized
• Intervention Model: Crossover Assignment
• Masking: None (Open Label)
• Primary Purpose: Diagnostic
• Official Title: Removal of Protein Bound Uremic Toxins in Chronic Hemodialysis Patients by Modified Plasma Separation and Adsorption Combined With Hemodialysis
• Study Start Date: Mar 1, 2006
• Study Completion Date: Oct 1, 2006

Outcome Measures

Primary Outcome Measures

1. Blood pressure []

2. Safety serological parameters []

3. Concentrations of protein bound uremic toxins []

Secondary Outcome Measures

1. Bleeding episodes []

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 70 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Over the age of 18

• Anuria

• Chronic hemodialysis dependence

Exclusion Criteria:

• No present history of bleeding episodes

• Cardiac diseases

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Rigshospitalet	Copenhagen		Denmark	2200

Sponsors and Collaborators

• Rigshospitalet, Denmark

Investigators

• Principal Investigator: Mette B Damholt, MD,Ph.d., Rigshospitalet P2132
• Principal Investigator: Soren D Ladefoged, MD, Rigshospitalet, Denmark

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00375635
• Other Study ID Numbers: MBD2006
• First Posted: Sep 13, 2006
• Last Update Posted: Sep 13, 2006
• Last Verified: Sep 1, 2006

• Keywords provided by , ,: mFPSA; Uremic toxins; Protein bound toxins; Uremia; Chronic hemodialysis
• Additional relevant MeSH terms: Uremia

Study Results

No Results Posted as of Sep 13, 2006