Elimination of Protein-bound Uremic Retention Solutes by Prometheus Artificial Hepatic System Versus Conventional Dialysis

• Sponsor: University Hospital, Ghent (Other)
• Overall Status: Withdrawn
• CT.gov ID: NCT00262353
• Collaborator: (none)
• Enrollment: 0
• Location: 1

Study Details

Study Description

Brief Summary

Comparison of the efficacy of dialysis by conventional dialysis versus Prometheus artificial hepatic system

Condition or Disease	Intervention/Treatment	Phase
Renal Failure, Chronic	Device: Dialysis with different artificial devices	N/A

Detailed Description

After inclusion, patients will be dialysed with low-flux artificial kidneys. 1 week of dialysis exists of 3 days of dialysis. In week 4, day 2, patients will be treated once with the Prometheus artificial hepatic system or with high-flux dialysis. The other days low-flux kidneys will be used. Week 5 and 6 are a wash-out period. Week 7 is identical to week 4 but the other system than in week 4 is used. Blood samples are taken at regular moments in week 3, week 4 (day 2) and week 7 (day 2).

Study Design

• Study Type: Interventional
• Actual Enrollment: 0 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Elimination of Protein-bound Uremic Retention Solutes by Prometheus Artificial Hepatic System Versus Conventional Dialysis

Outcome Measures

Primary Outcome Measures

1. Determination of the concentration of protein-bound toxins after treatment with different artificial devices []

Secondary Outcome Measures

1. Determination of the kinetics of protein-bound toxins after treatment with different artificial devices []

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Stable patients

• At least 3 months on dialysis

• Arterio-venous fistula

Exclusion Criteria:

• Diabetic patients

• Malignancies

• Acute illnesses

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University Hospital Ghent	Ghent		Belgium	9000

Sponsors and Collaborators

• University Hospital, Ghent

Investigators

• Principal Investigator: Raymond Vanholder, MD, PhD, University Hospital, Ghent

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Website of the University Hospital Ghent

Publications

None provided.

• Responsible Party: University Hospital, Ghent
• ClinicalTrials.gov Identifier: NCT00262353
• Other Study ID Numbers: 2004/416
• First Posted: Dec 6, 2005
• Last Update Posted: Jul 2, 2021
• Last Verified: Jul 1, 2021

• Additional relevant MeSH terms: Kidney Failure, Chronic

Study Results

No Results Posted as of Jul 2, 2021